21 CFR 886.1380 - Diagnostic condensing lens.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Diagnostic condensing lens. 886.1380 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1380 Diagnostic condensing lens. (a) Identification. A diagnostic condensing lens is a device used in binocular indirect ophthalmoscopy (a procedure...

21 CFR 886.1390 - Flexible diagnostic Fresnel lens.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Flexible diagnostic Fresnel lens. 886.1390 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1390 Flexible diagnostic Fresnel lens. (a) Identification. A flexible diagnostic Fresnel lens is a device that is a very thin lens which has...

21 CFR 886.1390 - Flexible diagnostic Fresnel lens.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1390 Flexible diagnostic Fresnel lens. (a) Identification. A flexible diagnostic Fresnel lens is a device that is a very thin lens which has its surface a concentric series of increasingly refractive zones. The device is intended to be applied...

21 CFR 874.1925 - Toynbee diagnostic tube.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Toynbee diagnostic tube. 874.1925 Section 874.1925...) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Diagnostic Devices § 874.1925 Toynbee diagnostic tube. (a) Identification. The toynbee diagnostic tube is a listening device intended to determine the degree of openness of...

21 CFR 874.1925 - Toynbee diagnostic tube.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Toynbee diagnostic tube. 874.1925 Section 874.1925...) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Diagnostic Devices § 874.1925 Toynbee diagnostic tube. (a) Identification. The toynbee diagnostic tube is a listening device intended to determine the degree of openness of...

21 CFR 886.1395 - Diagnostic Hruby fundus lens.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Diagnostic Hruby fundus lens. 886.1395 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1395 Diagnostic Hruby fundus lens. (a) Identification. A diagnostic Hruby fundus lens is a device that is a 55 diopter lens intended for use in the...

21 CFR 892.1700 - Diagnostic x-ray high voltage generator.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Diagnostic x-ray high voltage generator. 892.1700... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1700 Diagnostic x-ray high voltage generator. (a) Identification. A diagnostic x-ray high voltage generator is a device that is intended to...

21 CFR 892.1700 - Diagnostic x-ray high voltage generator.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Diagnostic x-ray high voltage generator. 892.1700... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1700 Diagnostic x-ray high voltage generator. (a) Identification. A diagnostic x-ray high voltage generator is a device that is intended to...

21 CFR 892.1700 - Diagnostic x-ray high voltage generator.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Diagnostic x-ray high voltage generator. 892.1700... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1700 Diagnostic x-ray high voltage generator. (a) Identification. A diagnostic x-ray high voltage generator is a device that is intended to...

21 CFR 892.1700 - Diagnostic x-ray high voltage generator.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Diagnostic x-ray high voltage generator. 892.1700... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1700 Diagnostic x-ray high voltage generator. (a) Identification. A diagnostic x-ray high voltage generator is a device that is intended to...

21 CFR 892.1700 - Diagnostic x-ray high voltage generator.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Diagnostic x-ray high voltage generator. 892.1700... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1700 Diagnostic x-ray high voltage generator. (a) Identification. A diagnostic x-ray high voltage generator is a device that is intended to...

78 FR 27404 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-10

...; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are... on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are... submitted a proposed collection of information entitled ``Guidance on Informed Consent for In Vitro...

75 FR 25268 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-07

...; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are... on Informed Consent For In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are...-796-5156, email: [email protected] . SUPPLEMENTARY INFORMATION: In the Federal Register of...

21 CFR 886.1395 - Diagnostic Hruby fundus lens.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1395 Diagnostic Hruby fundus lens. (a) Identification. A diagnostic Hruby fundus lens is a device that is a 55 diopter lens intended for use in the examination of the vitreous body and the fundus of the eye under slitlamp illumination and magnification. (b...

78 FR 9395 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0560... Request; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human... Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not...

Diagnostic devices for isothermal nucleic acid amplification.

PubMed

Chang, Chia-Chen; Chen, Chien-Cheng; Wei, Shih-Chung; Lu, Hui-Hsin; Liang, Yang-Hung; Lin, Chii-Wann

2012-01-01

Since the development of the polymerase chain reaction (PCR) technique, genomic information has been retrievable from lesser amounts of DNA than previously possible. PCR-based amplifications require high-precision instruments to perform temperature cycling reactions; further, they are cumbersome for routine clinical use. However, the use of isothermal approaches can eliminate many complications associated with thermocycling. The application of diagnostic devices for isothermal DNA amplification has recently been studied extensively. In this paper, we describe the basic concepts of several isothermal amplification approaches and review recent progress in diagnostic device development.

Diagnostic Devices for Isothermal Nucleic Acid Amplification

PubMed Central

Chang, Chia-Chen; Chen, Chien-Cheng; Wei, Shih-Chung; Lu, Hui-Hsin; Liang, Yang-Hung; Lin, Chii-Wann

2012-01-01

Since the development of the polymerase chain reaction (PCR) technique, genomic information has been retrievable from lesser amounts of DNA than previously possible. PCR-based amplifications require high-precision instruments to perform temperature cycling reactions; further, they are cumbersome for routine clinical use. However, the use of isothermal approaches can eliminate many complications associated with thermocycling. The application of diagnostic devices for isothermal DNA amplification has recently been studied extensively. In this paper, we describe the basic concepts of several isothermal amplification approaches and review recent progress in diagnostic device development. PMID:22969402

Initial experience with the Cardiva Boomerang vascular closure device in diagnostic catheterization.

PubMed

Doyle, Brendan J; Godfrey, Michael J; Lennon, Ryan J; Ryan, James L; Bresnahan, John F; Rihal, Charanjit S; Ting, Henry H

2007-02-01

The authors studied the safety and efficacy of the Cardiva Boomerang vascular closure device in patients undergoing diagnostic cardiac catheterization. Conventional vascular closure devices (sutures, collagen plugs, or metal clips) have been associated with catastrophic complications including arterial occlusion and foreign body infections; furthermore, they cannot be utilized in patients with peripheral vascular disease or vascular access site in a vessel other than the common femoral artery. The Cardiva Boomerang device facilitates vascular hemostasis without leaving any foreign body behind at the access site, can be used in peripheral vascular disease, and can be used in vessels other than the common femoral artery A total of 96 patients undergoing transfemoral diagnostic cardiac catheterization were included in this study, including 25 (26%) patients with contraindications to conventional closure devices. Femoral angiography was performed prior to deployment of the Cardiva Boomerang closure device. Patients were ambulated at 1 hr after hemostasis was achieved. The device was successfully deployed and hemostasis achieved with the device alone in 95 (99%) patients. The device failed to deploy in 1 (1%) patient and required conversion to standard manual compression. Minor complications were observed in 5 (5%) patients. No patients experienced major complications including femoral hematoma > 4 cm, red blood cell transfusion, retroperitoneal bleed, arteriovenous fistula, pseudoaneurysm, infection, arterial occlusion, or vascular surgery. The Cardiva Boomerang device is safe and effective in patients undergoing diagnostic cardiac catheterization using the transfemoral approach, facilitating early ambulation with low rates of vascular complications. (c) 2006 Wiley-Liss, Inc.

76 FR 69034 - Microbiology Devices; Classification of In Vitro Diagnostic Device for Yersinia Species Detection

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-07

... Drug Administration 21 CFR Part 866 Microbiology Devices; Classification of In Vitro Diagnostic Device... CFR Part 866 [Docket No. FDA-2011-N-0729] Microbiology Devices; Classification of In Vitro Diagnostic... of the Microbiology Devices Advisory Panel (the panel). FDA is publishing in this document the...

21 CFR 892.1760 - Diagnostic x-ray tube housing assembly.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Diagnostic x-ray tube housing assembly. 892.1760... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1760 Diagnostic x-ray tube housing assembly. (a) Identification. A diagnostic x-ray tube housing assembly is an x-ray generating tube encased...

21 CFR 892.1760 - Diagnostic x-ray tube housing assembly.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Diagnostic x-ray tube housing assembly. 892.1760... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1760 Diagnostic x-ray tube housing assembly. (a) Identification. A diagnostic x-ray tube housing assembly is an x-ray generating tube encased...

21 CFR 892.1760 - Diagnostic x-ray tube housing assembly.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Diagnostic x-ray tube housing assembly. 892.1760... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1760 Diagnostic x-ray tube housing assembly. (a) Identification. A diagnostic x-ray tube housing assembly is an x-ray generating tube encased...

21 CFR 892.1760 - Diagnostic x-ray tube housing assembly.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Diagnostic x-ray tube housing assembly. 892.1760... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1760 Diagnostic x-ray tube housing assembly. (a) Identification. A diagnostic x-ray tube housing assembly is an x-ray generating tube encased...

21 CFR 892.1760 - Diagnostic x-ray tube housing assembly.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Diagnostic x-ray tube housing assembly. 892.1760... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1760 Diagnostic x-ray tube housing assembly. (a) Identification. A diagnostic x-ray tube housing assembly is an x-ray generating tube encased...

21 CFR 890.1375 - Diagnostic electromyograph.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Diagnostic Devices § 890.1375 Diagnostic..., and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis...

21 CFR 890.1850 - Diagnostic muscle stimulator.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Diagnostic Devices § 890.1850 Diagnostic... electromyograph machine to initiate muscle activity. It is intended for medical purposes, such as to diagnose...

21 CFR 890.1375 - Diagnostic electromyograph.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Diagnostic electromyograph. 890.1375 Section 890.1375 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Diagnostic Devices § 890.1375 Diagnostic...

21 CFR 890.1375 - Diagnostic electromyograph.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Diagnostic electromyograph. 890.1375 Section 890.1375 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Diagnostic Devices § 890.1375 Diagnostic...

21 CFR 890.1375 - Diagnostic electromyograph.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Diagnostic electromyograph. 890.1375 Section 890.1375 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Diagnostic Devices § 890.1375 Diagnostic...

21 CFR 890.1375 - Diagnostic electromyograph.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Diagnostic electromyograph. 890.1375 Section 890.1375 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Diagnostic Devices § 890.1375 Diagnostic...

21 CFR 892.1570 - Diagnostic ultrasonic transducer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Diagnostic ultrasonic transducer. 892.1570 Section 892.1570 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1570 Diagnostic ultrasonic transducer...

21 CFR 890.1850 - Diagnostic muscle stimulator.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Diagnostic muscle stimulator. 890.1850 Section 890.1850 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Diagnostic Devices § 890.1850 Diagnostic...

21 CFR 890.1850 - Diagnostic muscle stimulator.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Diagnostic muscle stimulator. 890.1850 Section 890.1850 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Diagnostic Devices § 890.1850 Diagnostic...

21 CFR 890.1850 - Diagnostic muscle stimulator.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Diagnostic muscle stimulator. 890.1850 Section 890.1850 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Diagnostic Devices § 890.1850 Diagnostic...

21 CFR 890.1850 - Diagnostic muscle stimulator.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Diagnostic muscle stimulator. 890.1850 Section 890.1850 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Diagnostic Devices § 890.1850 Diagnostic...

Portable Diagnostics and Rapid Germination

DOE Office of Scientific and Technical Information (OSTI.GOV)

Dunn, Zachary Spencer

In the Bioenergy and Defense Department of Sandia National Laboratories, characterization of the BaDx (Bacillus anthracis diagnostic cartridge) was performed and rapid germination chemistry was investigated. BaDx was tested with complex sample matrixes inoculated with Bacillus anthracis, and the trials proved that BaDx will detect Bacillus anthracis in a variety of the medium, such as dirt, serum, blood, milk, and horse fluids. The dimensions of the device were altered to accommodate an E. coli or Listeria lateral flow immunoassay, and using a laser printer, BaDx devices were manufactured to identify E. coli and Listeria. Initial testing with E. coli versionsmore » of BaDx indicate that the device will be viable as a portable diagnostic cartridge. The device would be more effective with faster bacteria germination; hence studies were performed the use of rapid germination chemistry. Trials with calcium dipicolinic acid displayed increased cell germination, as shown by control studies using a microplate reader. Upon lyophilization the rapid germination chemistry failed to change growth patterns, indicating that the calcium dipicolinic acid was not solubilized under the conditions tested. Although incompatible with the portable diagnostic device, the experiments proved that the rapid germination chemistry was effective in increasing cell germination.« less

21 CFR 882.1560 - Skin potential measurement device.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Skin potential measurement device. 882.1560... (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1560 Skin potential measurement device. (a) Identification. A skin potential measurement device is a general diagnostic device...

21 CFR 882.1560 - Skin potential measurement device.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Skin potential measurement device. 882.1560... (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1560 Skin potential measurement device. (a) Identification. A skin potential measurement device is a general diagnostic device...

21 CFR 882.1560 - Skin potential measurement device.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Skin potential measurement device. 882.1560... (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1560 Skin potential measurement device. (a) Identification. A skin potential measurement device is a general diagnostic device...

21 CFR 882.1560 - Skin potential measurement device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Skin potential measurement device. 882.1560... (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1560 Skin potential measurement device. (a) Identification. A skin potential measurement device is a general diagnostic device...

Non- contacting capacitive diagnostic device

DOEpatents

Ellison, Timothy

2005-07-12

A non-contacting capacitive diagnostic device includes a pulsed light source for producing an electric field in a semiconductor or photovoltaic device or material to be evaluated and a circuit responsive to the electric field. The circuit is not in physical contact with the device or material being evaluated and produces an electrical signal characteristic of the electric field produced in the device or material. The diagnostic device permits quality control and evaluation of semiconductor or photovoltaic device properties in continuous manufacturing processes.

Improved cardiovascular diagnostic accuracy by pocket size imaging device in non-cardiologic outpatients: the NaUSiCa (Naples Ultrasound Stethoscope in Cardiology) study

PubMed Central

2010-01-01

Miniaturization has evolved in the creation of a pocket-size imaging device which can be utilized as an ultrasound stethoscope. This study assessed the additional diagnostic power of pocket size device by both experts operators and trainees in comparison with physical examination and its appropriateness of use in comparison with standard echo machine in a non-cardiologic population. Three hundred four consecutive non cardiologic outpatients underwent a sequential assessment including physical examination, pocket size imaging device and standard Doppler-echo exam. Pocket size device was used by both expert operators and trainees (who received specific training before the beginning of the study). All the operators were requested to give only visual, qualitative insights on specific issues. All standard Doppler-echo exams were performed by expert operators. One hundred two pocket size device exams were performed by experts and two hundred two by trainees. The time duration of the pocket size device exam was 304 ± 117 sec. Diagnosis of cardiac abnormalities was made in 38.2% of cases by physical examination and in 69.7% of cases by physical examination + pocket size device (additional diagnostic power = 31.5%, p < 0.0001). The overall K between pocket size device and standard Doppler-echo was 0.67 in the pooled population (0.84 by experts and 0.58 by trainees). K was suboptimal for trainees in the eyeball evaluation of ejection fraction, left atrial dilation and right ventricular dilation. Overall sensitivity was 91% and specificity 76%. Sensitivity and specificity were lower in trainees than in experts. In conclusion, pocket size device showed a relevant additional diagnostic value in comparison with physical examination. Sensitivity and specificity were good in experts and suboptimal in trainees. Specificity was particularly influenced by the level of experience. Training programs are needed for pocket size device users. PMID:21110840

Diagnostic and therapeutic yield of a patient-controlled portable EEG device with dry electrodes for home-monitoring neurological outpatients-rationale and protocol of the HOMEONE pilot study.

PubMed

Neumann, Thomas; Baum, Anne Katrin; Baum, Ulrike; Deike, Renate; Feistner, Helmut; Hinrichs, Hermann; Stokes, Joseph; Robra, Bernt-Peter

2018-01-01

The HOME ONE study is part of the larger HOME project, which aims to provide evidence of diagnostic and therapeutic yield ("change of management") of a patient-controlled portable EEG device with dry electrodes for the purposes of EEG home-monitoring neurological outpatients. The HOME ONE study is the first step in the process of investigating whether outpatient EEG home-monitoring changes the diagnosis and treatment of patients in comparison to conventional EEG ("change of management"). Both EEG devices (conventional and portable) will be systematically compared via a two-phase intra-individual assessment.In the first phase (pilot study phase), both EEG devices will be used within neurologist practices (all other things being equal). This pilot study (involving 130 patients) will evaluate the technical usability and efficacy of the new portable dry electrode EEG recorder in comparison to conventional EEG devices. Judgements will be based on technical assessments and EEG record examinations of private practitioners and two experienced neurologists (percent of concordant readings and kappa values).The second phase (feasibility study phase) aims to assess patients' acceptability and feasibility of the EEG home-monitoring and will provide insights into the extent diagnostic and therapeutic yields can be expected.For this purpose, a conventional EEG will be recorded in neurologist practices. Thereafter, the practice staff will instruct the patients on how the portable EEG device functions. The patients will subsequently use the devices in their home environment.The evaluation will compare the before and after documented diagnostic findings and the therapeutic consequences of the private practitioners with those of two experienced neurologists. To the best of our knowledge, this will be the first study of its kind to examine new approaches to diagnosing unclear consciousness disorders or other disorders of the CNS or the cardiovascular system through the use of a patient-controlled portable EEG device with dry electrodes for the purpose of home-monitoring neurological outpatients. If the two phases of the HOME ONE study provide sufficient evidence of diagnostic and therapeutic yields, this would justify (indication-specific) full-scale randomized controlled trials or observational studies. DRKS DRKS00012685. Registered 9 August 2017, retrospectively registered.

21 CFR 886.1660 - Gonioscopic prism.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1660 Gonioscopic prism. (a) Identification. A gonioscopic prism is a device that is a prism intended to be placed on the eye to study the anterior chamber. The device may have angled mirrors to facilitate visualization of anatomical features. (b...

Fully 3D printed integrated reactor array for point-of-care molecular diagnostics.

PubMed

Kadimisetty, Karteek; Song, Jinzhao; Doto, Aoife M; Hwang, Young; Peng, Jing; Mauk, Michael G; Bushman, Frederic D; Gross, Robert; Jarvis, Joseph N; Liu, Changchun

2018-06-30

Molecular diagnostics that involve nucleic acid amplification tests (NAATs) are crucial for prevention and treatment of infectious diseases. In this study, we developed a simple, inexpensive, disposable, fully 3D printed microfluidic reactor array that is capable of carrying out extraction, concentration and isothermal amplification of nucleic acids in variety of body fluids. The method allows rapid molecular diagnostic tests for infectious diseases at point of care. A simple leak-proof polymerization strategy was developed to integrate flow-through nucleic acid isolation membranes into microfluidic devices, yielding a multifunctional diagnostic platform. Static coating technology was adopted to improve the biocompatibility of our 3D printed device. We demonstrated the suitability of our device for both end-point colorimetric qualitative detection and real-time fluorescence quantitative detection. We applied our diagnostic device to detection of Plasmodium falciparum in plasma samples and Neisseria meningitides in cerebrospinal fluid (CSF) samples by loop-mediated, isothermal amplification (LAMP) within 50 min. The detection limits were 100 fg for P. falciparum and 50 colony-forming unit (CFU) for N. meningitidis per reaction, which are comparable to that of benchtop instruments. This rapid and inexpensive 3D printed device has great potential for point-of-care molecular diagnosis of infectious disease in resource-limited settings. Copyright © 2018 Elsevier B.V. All rights reserved.

Accuracy of point-of-care serum creatinine devices for detecting patients at risk of contrast-induced nephropathy: a critical overview.

PubMed

Martínez Lomakin, Felipe; Tobar, Catalina

2014-12-01

Contrast-induced nephropathy (CIN) is a common event in hospitals, with reported incidences ranging from 1 to 30%. Patients with underlying kidney disease have an increased risk of developing CIN. Point-of-care (POC) creatinine devices are handheld devices capable of providing quantitative data on a patient's kidney function that could be useful in stratifying preventive measures. This overview aims to synthesize the current evidence on diagnostic accuracy and clinical utility of POC creatinine devices in detecting patients at risk of CIN. Five databases were searched for diagnostic accuracy studies or clinical trials that evaluated the usefulness of POC devices in detecting patients at risk of CIN. Selected articles were critically appraised to assess their individual risk of bias by the use of standard criteria; 13 studies were found that addressed the diagnostic accuracy or clinical utility of POC creatinine devices. Most studies incurred a moderate to high risk of bias. Overall concordance between POC devices and reference standards (clinical laboratory procedures) was found to be moderate, with 95% limits of agreement often lying between -35.4 and +35.4 µmol/L (-0.4 and +0.4 mg/dL). Concordance was shown to decrease with worsening kidney function. Data on the clinical utility of these devices were limited, but a significant reduction in time to diagnosis was reported in two studies. Overall, POC creatinine devices showed a moderate concordance with standard clinical laboratory creatinine measurements. Several biases could have induced optimism in these estimations. Results obtained from these devices may be unreliable in cases of severe kidney failure. Randomized trials are needed to address the clinical utility of these devices.

Statistical innovations in the medical device world sparked by the FDA.

PubMed

Campbell, Gregory; Yue, Lilly Q

2016-01-01

The world of medical devices while highly diverse is extremely innovative, and this facilitates the adoption of innovative statistical techniques. Statisticians in the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) have provided leadership in implementing statistical innovations. The innovations discussed include: the incorporation of Bayesian methods in clinical trials, adaptive designs, the use and development of propensity score methodology in the design and analysis of non-randomized observational studies, the use of tipping-point analysis for missing data, techniques for diagnostic test evaluation, bridging studies for companion diagnostic tests, quantitative benefit-risk decisions, and patient preference studies.

21 CFR 890.1385 - Diagnostic electromyograph needle electrode.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Diagnostic electromyograph needle electrode. 890.1385 Section 890.1385 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Diagnostic Devices § 890...

21 CFR 890.1385 - Diagnostic electromyograph needle electrode.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Diagnostic electromyograph needle electrode. 890.1385 Section 890.1385 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Diagnostic Devices § 890...

21 CFR 890.1385 - Diagnostic electromyograph needle electrode.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Diagnostic electromyograph needle electrode. 890.1385 Section 890.1385 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Diagnostic Devices § 890...

21 CFR 890.1385 - Diagnostic electromyograph needle electrode.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Diagnostic electromyograph needle electrode. 890.1385 Section 890.1385 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Diagnostic Devices § 890...

21 CFR 890.1385 - Diagnostic electromyograph needle electrode.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Diagnostic electromyograph needle electrode. 890.1385 Section 890.1385 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Diagnostic Devices § 890...

21 CFR 870.1435 - Single-function, preprogrammed diagnostic computer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Single-function, preprogrammed diagnostic computer. 870.1435 Section 870.1435 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1435...

76 FR 28689 - Microbiology Devices; Classification of In Vitro Diagnostic Device for Bacillus Species Detection

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-18

.... FDA-2011-N-0103] Microbiology Devices; Classification of In Vitro Diagnostic Device for Bacillus... of the Microbiology Devices Advisory Panel (the Panel). In addition, the proposed rule would... in the Federal Register. 1. Transcript of the FDA Microbiology Devices Panel meeting, March 7, 2002...

78 FR 18988 - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-28

...] Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to... announcing the availability of the guidance entitled ``Establishing the Performance Characteristics of In... document entitled ``Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the...

76 FR 27331 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-11

... Characteristics of In Vitro Diagnostic Devices for Chlamydia Trachomatis and/or Neisseria Gonorrhoeae: Screening... entitled ``Establishing the Performance Characteristics of In Vitro Diagnostic Devices for Chlamydia... clinical performance of in vitro diagnostic devices (IVDs) intended for C. trachomatis and/or N...

Image-Directed Fine-needle Aspiration Biopsy of the Thyroid with Safety-engineered Devices

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sibbitt, Randy R., E-mail: THESIBB2@aol.com; Palmer, Dennis J., E-mail: lyonscreek@aol.com; Sibbitt, Wilmer L., E-mail: wsibbitt@salud.unm.edu

2011-10-15

Purpose: The purpose of the present study was to integrate safety-engineered devices into outpatient fine-needle aspiration (FNA) biopsy of the thyroid in an interventional radiology practice. Materials and Methods: The practice center is a tertiary referral center for image-directed FNA thyroid biopsies in difficult patients referred by the primary care physician, endocrinologist, or otolaryngologist. As a departmental quality of care and safety improvement program, we instituted integration of safety devices into our thyroid biopsy procedures and determined the effect on outcome (procedural pain, diagnostic biopsies, inadequate samples, complications, needlesticks to operator, and physician satisfaction) before institution of safety devices (54more » patients) and after institution of safety device implementation (56 patients). Safety devices included a patient safety technology-the mechanical aspirating syringe (reciprocating procedure device), and a health care worker safety technology (antineedlestick safety needle). Results: FNA of thyroid could be readily performed with the safety devices. Safety-engineered devices resulted in a 49% reduction in procedural pain scores (P < 0.0001), a 56% reduction in significant pain (P < 0.002), a 21% increase in operator satisfaction (P < 0.0001), and a 5% increase in diagnostic specimens (P = 0.5). No needlesticks to health care workers or patient injuries occurred during the study. Conclusions: Safety-engineered devices to improve both patient and health care worker safety can be successfully integrated into diagnostic FNA of the thyroid while maintaining outcomes and improving safety.« less

Drug-device trials for infectious diseases: CDRH perspective.

PubMed

Meier, Kristen L; Gitterman, Steven

2011-05-01

Assessing the performance of new diagnostic tests for infectious diseases has traditionally focused on comparing the new assay against a reference standard such as culture. In this paper, we suggest that clinical trial designs with both a diagnostic and therapeutic component may be necessary to evaluate the safety and effectiveness of nonmicrobiologically based assays, with a specific emphasis on the test/marker-stratified design. General design challenges for trials of infectious diseases that simultaneously study both diagnostic and therapeutic components (eg, both devices and drugs) are also discussed.

76 FR 28688 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-18

... Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus Species Detection AGENCY: Food and... Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection.'' This draft guidance document describes means by which in vitro diagnostic devices for Bacillus species (spp.) detection may comply with...

75 FR 24960 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-06

..., to permit the use of investigational in vitro diagnostic devices to identify chemical, biological... consent is required for the use of an investigational in vitro diagnostic device. This exception will apply to those situations in which the in vitro investigational diagnostic device is used to prepare for...

The upgraded Large Plasma Device, a machine for studying frontier basic plasma physics.

PubMed

Gekelman, W; Pribyl, P; Lucky, Z; Drandell, M; Leneman, D; Maggs, J; Vincena, S; Van Compernolle, B; Tripathi, S K P; Morales, G; Carter, T A; Wang, Y; DeHaas, T

2016-02-01

In 1991 a manuscript describing an instrument for studying magnetized plasmas was published in this journal. The Large Plasma Device (LAPD) was upgraded in 2001 and has become a national user facility for the study of basic plasma physics. The upgrade as well as diagnostics introduced since then has significantly changed the capabilities of the device. All references to the machine still quote the original RSI paper, which at this time is not appropriate. In this work, the properties of the updated LAPD are presented. The strategy of the machine construction, the available diagnostics, the parameters available for experiments, as well as illustrations of several experiments are presented here.

New diagnostic pathways urgently needed. Protocol of PET Guidance I pilot study: positron emission tomography in suspected cardiac implantable electronic device-related infection.

PubMed

Marciniak-Emmons, Marta Barbara; Sterliński, Maciej; Syska, Paweł; Maciąg, Aleksander; Farkowski, Michał Mirosław; Firek, Bohdan; Dziuk, Mirosław; Zając, Dariusz; Pytkowski, Mariusz; Szwed, Hanna

2016-01-01

Cardiovascular implantable electronic device (CIED) infection is a complication of increasing incidence. We present a protocol of an observational case control clinical trial "Positron Emission Tomography Combined With Computed Tomography (PET CT) in Suspected Cardiac Implantable Electronic Device Infection, a Pilot Study - PET Guidance I" (NCT02196753). The aim of this observational clinical trial is to assess and standardise diagnostic algorithms for CIED infections (lead-dependent infective endocarditis, generator pocket infection, fever of unknown origin) with PET CT in Poland. Study group will consist of 20 patients with initial diagnosis of CIED-related infection paired with a control group of 20 patients with implanted CIEDs, who underwent PET CT due to other non-infectious indications and have no data for infectious process in follow-up. All patients included in the study will undergo standard diagnostic pro-cess. Conventional/standard diagnostic and therapeutic process will consist of: medical interview, physical examination, laboratory tests, blood cultures; imaging studies: echocardiography: transthoracic (TTE), and, if there are no contraindications transoesophageal, computed tomography scan for pulmonary embolism if indicated; if there are abnormalities in other systems, decisions concerning further diagnostics will be made at the physician's discretion. As well as standard diagnostic procedures, patients will undergo whole body PET CT scan to localise infection or inflammation. Diagnosis and therapeutic decision will be obtained from the Study Committee. Follow-up will be held within six months with control visits at three and six months. During each follow-up visit, all patients will undergo laboratory tests, two blood cultures collected 1 h apart, and TTE. In case of actual clinical suspicion of infective endocarditis or local generator pocket infection, patients will be referred for further diagnostics. Endpoints for the results assessment - primary endpoints are to standardise PET CT in the diagnostic process: sensitivity, specificity, positive predictive value, and negative predictive value of the diagnosis made by PET CT; secondary endpoints are: assessment of usefulness of PET CT for detection of remote infective complications (metastatic abscesses, infected pulmonary emboli), incidence of particular localisations of infection, influence of PET CT on therapeutic decision: confirmation or change of decision based on PET CT, safety and complications of diagnostic process of CIED-related infections with PET CT. Evaluation of PET CT use for device-related infections in a case control study may be conclusive and improve diagnostic pathway.

WE-G-204-08: Optimized Digital Radiographic Technique for Lost Surgical Devices/Needle Identification

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gorman, A; Seabrook, G; Brakken, A

Purpose: Small surgical devices and needles are used in many surgical procedures. Conventionally, an x-ray film is taken to identify missing devices/needles if post procedure count is incorrect. There is no data to indicate smallest surgical devices/needles that can be identified with digital radiography (DR), and its optimized acquisition technique. Methods: In this study, the DR equipment used is a Canon RadPro mobile with CXDI-70c wireless DR plate, and the same DR plate on a fixed Siemens Multix unit. Small surgical devices and needles tested include Rubber Shod, Bulldog, Fogarty Hydrogrip, and needles with sizes 3-0 C-T1 through 8-0 BV175-6.more » They are imaged with PMMA block phantoms with thickness of 2–8 inch, and an abdomen phantom. Various DR techniques are used. Images are reviewed on the portable x-ray acquisition display, a clinical workstation, and a diagnostic workstation. Results: all small surgical devices and needles are visible in portable DR images with 2–8 inch of PMMA. However, when they are imaged with the abdomen phantom plus 2 inch of PMMA, needles smaller than 9.3 mm length can not be visualized at the optimized technique of 81 kV and 16 mAs. There is no significant difference in visualization with various techniques, or between mobile and fixed radiography unit. However, there is noticeable difference in visualizing the smallest needle on a diagnostic reading workstation compared to the acquisition display on a portable x-ray unit. Conclusion: DR images should be reviewed on a diagnostic reading workstation. Using optimized DR techniques, the smallest needle that can be identified on all phantom studies is 9.3 mm. Sample DR images of various small surgical devices/needles available on diagnostic workstation for comparison may improve their identification. Further in vivo study is needed to confirm the optimized digital radiography technique for identification of lost small surgical devices and needles.« less

Paper-based CRP Monitoring Devices

NASA Astrophysics Data System (ADS)

Lin, Shang-Chi; Tseng, Chung-Yuh; Lai, Po-Liang; Hsu, Min-Yen; Chu, Shueh-Yao; Tseng, Fan-Gang; Cheng, Chao-Min

2016-12-01

Here, we discuss the development of a paper-based diagnostic device that is inexpensive, portable, easy-to-use, robust, and capable of running simultaneous tests to monitor a relevant inflammatory protein for clinical diagnoses i.e. C-reactive protein (CRP). In this study, we first attempted to make a paper-based diagnostic device via the wax printing method, a process that was used in previous studies. This device has two distinct advantages: 1) reduced manufacturing and assay costs and operation duration via using wax printing method to define hydrophobic boundaries (for fluidic devices or general POC devices); and, 2) the hydrophilicity of filter paper, which is used to purify and chromatographically correct interference caused by whole blood components with a tiny amount of blood sample (only 5 μL). Diagnosis was based on serum stain length retained inside the paper channels of our device. This is a balanced function between surface tension and chromatographic force following immune reactions (CRP assays) with a paper-embedded biomarker.

76 FR 1169 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-07

... Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use AGENCY: Food and Drug... Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional... required for: (1) In vitro diagnostic devices (IVDs), intended for professional use under 21 CFR 809.10...

Use of diagnostic imaging procedures and fetal monitoring devices in the care of pregnant women.

PubMed

Moore, R M; Jeng, L L; Kaczmarek, R G; Placek, P J

1990-01-01

Medical devices and diagnostic imaging procedures such as ultrasound, X-rays, and electronic fetal monitoring devices are used in the medical care of many pregnant women today. The responsibility for the safety and effectiveness of these diagnostic technologies is shared by a number of Public Health Service agencies, one of which is the Center for Devices and Radiological Health (CDRH), a unit within the Food and Drug Administration. The CDRH collaborated with the National Center for Health Statistics (NCHS) in conducting a study of recent trends in the uses of diagnostic ultrasound, medical X-rays, and electronic fetal monitoring devices in the medical care of pregnant women. This study used data from the 1980 National Natality and Fetal Mortality Surveys and the 1987 pretest to the National Maternal and Infant Health Survey. Hospitals and prenatal care providers of the pregnant women contributed information regarding the use of these medical devices. Between 1980 and 1987, ultrasound use more than doubled, increasing from 33.5 percent of pregnancies in 1980 to 78.8 percent in 1987 (P less than 0.001). More ultrasound examinations were performed earlier in gestation in 1987 than in 1980, with 10.1 percent being performed during the first trimester in 1987, compared with 6.9 percent in 1980 (P less than 0.001). Use of external electronic fetal monitoring devices during delivery also increased significantly between 1980 and 1987, from 33.5 percent to 74.6 percent (P less than 0.001). Use of medical X-rays among women with live births remained relatively unchanged, 15.0 percent in 1980 and 15.3 percent in 1987 (P = .282). The implications of these trends are discussed.

Device for wavelength-selective imaging

DOEpatents

Frangioni, John V.

2010-09-14

An imaging device captures both a visible light image and a diagnostic image, the diagnostic image corresponding to emissions from an imaging medium within the object. The visible light image (which may be color or grayscale) and the diagnostic image may be superimposed to display regions of diagnostic significance within a visible light image. A number of imaging media may be used according to an intended application for the imaging device, and an imaging medium may have wavelengths above, below, or within the visible light spectrum. The devices described herein may be advantageously packaged within a single integrated device or other solid state device, and/or employed in an integrated, single-camera medical imaging system, as well as many non-medical imaging systems that would benefit from simultaneous capture of visible-light wavelength images along with images at other wavelengths.

Optical coherence tomography for glaucoma diagnosis: An evidence based meta-analysis.

PubMed

Kansal, Vinay; Armstrong, James J; Pintwala, Robert; Hutnik, Cindy

2018-01-01

Early detection, monitoring and understanding of changes in the retina are central to the diagnosis of glaucomatous optic neuropathy, and vital to reduce visual loss from this progressive condition. The main objective of this investigation was to compare glaucoma diagnostic accuracy of commercially available optical coherence tomography (OCT) devices (Zeiss Stratus, Zeiss Cirrus, Heidelberg Spectralis and Optovue RTVue, and Topcon 3D-OCT). 16,104 glaucomatous and 11,543 normal eyes reported in 150 studies. Between Jan. 2017 and Feb 2017, MEDLINE®, EMBASE®, CINAHL®, Cochrane Library®, Web of Science®, and BIOSIS® were searched for studies assessing glaucoma diagnostic accuracy of the aforementioned OCT devices. Meta-analysis was performed pooling area under the receiver operating characteristic curve (AUROC) estimates for all devices, stratified by OCT type (RNFL, macula), and area imaged. 150 studies with 16,104 glaucomatous and 11,543 normal control eyes were included. Key findings: AUROC of glaucoma diagnosis for RNFL average for all glaucoma patients was 0.897 (0.887-0.906, n = 16,782 patient eyes), for macula ganglion cell complex (GCC) was 0.885 (0.869-0.901, n = 4841 eyes), for macula ganglion cell inner plexiform layer (GCIPL) was 0.858 (0.835-0.880, n = 4211 eyes), and for total macular thickness was 0.795 (0.754-0.834, n = 1063 eyes). The classification capability was similar across all 5 OCT devices. More diagnostically favorable AUROCs were demonstrated in patients with increased glaucoma severity. Diagnostic accuracy of RNFL and segmented macular regions (GCIPL, GCC) scans were similar and higher than total macular thickness. This study provides a synthesis of contemporary evidence with features of robust inclusion criteria and large sample size. These findings may provide guidance to clinicians when navigating this rapidly evolving diagnostic area characterized by numerous options.

21 CFR 886.1660 - Gonioscopic prism.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Gonioscopic prism. 886.1660 Section 886.1660 Food... DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1660 Gonioscopic prism. (a) Identification. A gonioscopic prism is a device that is a prism intended to be placed on the eye to study the anterior chamber...

21 CFR 886.1660 - Gonioscopic prism.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Gonioscopic prism. 886.1660 Section 886.1660 Food... DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1660 Gonioscopic prism. (a) Identification. A gonioscopic prism is a device that is a prism intended to be placed on the eye to study the anterior chamber...

21 CFR 886.1660 - Gonioscopic prism.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Gonioscopic prism. 886.1660 Section 886.1660 Food... DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1660 Gonioscopic prism. (a) Identification. A gonioscopic prism is a device that is a prism intended to be placed on the eye to study the anterior chamber...

21 CFR 886.1660 - Gonioscopic prism.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Gonioscopic prism. 886.1660 Section 886.1660 Food... DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1660 Gonioscopic prism. (a) Identification. A gonioscopic prism is a device that is a prism intended to be placed on the eye to study the anterior chamber...

CONFERENCE REPORT: Summary of the 16th IAEA Technical Meeting on 'Research using Small Fusion Devices'

NASA Astrophysics Data System (ADS)

Gribkov, V.; Van Oost, G.; Malaquias, A.; Herrera, J.

2006-10-01

Common research topics that are being studied in small, medium and large devices such as H-mode like or improved confinement, turbulence and transport are reported. These included modelling and diagnostic developments for edge and core, to characterize plasma density, temperature, electric potential, plasma flows, turbulence scale, etc. Innovative diagnostic methods were designed and implemented which could be used to develop experiments in small devices (in some cases not possible in large devices due to higher power deposition) to allow a better understanding of plasma edge and core properties. Reports are given addressing research in linear devices that can be used to study particular plasma physics topics relevant for other magnetic confinement devices such as the radial transport and the modelling of self-organized plasma jets involved in spheromak-like plasma formation. Some aspects of the work presented are of interest to the astrophysics community since they are believed to shed light on the basis of the physics of stellar jets. On the dense magnetized plasmas (DMP) topic, the present status of research, operation of new devices, plasma dynamics modelling and diagnostic developments is reported. The main devices presented belong to the class of Z-pinches, mostly plasma foci, and several papers were presented under this topic. The physics of DMP is important both for the main-stream fusion investigations as well as for providing the basis for elaboration of new concepts. New high-current technology introduced in the DMP devices design and construction make these devices nowadays more reliably fitted to various applications and give the possibility to widen the energy range used by them in both directions—to the multi-MJ level facilities and down to miniature plasma focus devices with energy of just a few J.

The Development of a Diagnostic-Prescriptive Tool for Undergraduates Seeking Information for a Social Science/Humanities Assignment. III. Enabling Devices.

ERIC Educational Resources Information Center

Cole, Charles; Cantero, Pablo; Ungar, Andras

2000-01-01

This article focuses on a study of undergraduates writing an essay for a remedial writing course that tested two devices, an uncertainty expansion device and an uncertainty reduction device. Highlights include Kuhlthau's information search process model, and enabling technology devices for the information needs of information retrieval system…

21 CFR 892.1850 - Radiographic film cassette.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Radiographic film cassette. 892.1850 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1850 Radiographic film cassette. (a) Identification. A radiographic film cassette is a device intended for use during diagnostic x-ray procedures to...

21 CFR 892.1850 - Radiographic film cassette.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Radiographic film cassette. 892.1850 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1850 Radiographic film cassette. (a) Identification. A radiographic film cassette is a device intended for use during diagnostic x-ray procedures to...

21 CFR 892.1850 - Radiographic film cassette.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Radiographic film cassette. 892.1850 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1850 Radiographic film cassette. (a) Identification. A radiographic film cassette is a device intended for use during diagnostic x-ray procedures to...

21 CFR 892.1850 - Radiographic film cassette.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Radiographic film cassette. 892.1850 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1850 Radiographic film cassette. (a) Identification. A radiographic film cassette is a device intended for use during diagnostic x-ray procedures to...

78 FR 25273 - Determination and Declaration Regarding Emergency Use of in Vitro Diagnostics for Detection of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-30

... Respiratory Protection Devices, and Respiratory Support Devices signed by then Secretary Michael Leavitt on... Act Declaration for Pandemic Influenza Diagnostics, Personal Respiratory Protection Devices, and Respiratory Support Devices signed by then Secretary Michael Leavitt on December 17, 2008. Notice of the EUAs...

Flexible substrate-based devices for point-of-care diagnostics

PubMed Central

Wang, ShuQi; Chinnasamy, Thiruppathiraja; Lifson, Mark; Inci, Fatih; Demirci, Utkan

2016-01-01

Point-of-care (POC) diagnostics play an important role in delivering healthcare, particularly for clinical management and disease surveillance in both developed and developing countries. Currently, the majority of POC diagnostics utilize paper substrates owing to their affordability, disposability, and mass production capability. Recently, flexible polymer substrates have been investigated due to their enhanced physicochemical properties, potential to be integrated into wearable devices with wireless communications for personalized health monitoring, and ability to be customized for POC diagnostics. Here, we focus on the latest advances in developing flexible substrate-based diagnostic devices, including paper and polymers, and their clinical applications at the POC. PMID:27344425

Flexible Substrate-Based Devices for Point-of-Care Diagnostics.

PubMed

Wang, ShuQi; Chinnasamy, Thiruppathiraja; Lifson, Mark A; Inci, Fatih; Demirci, Utkan

2016-11-01

Point-of-care (POC) diagnostics play an important role in delivering healthcare, particularly for clinical management and disease surveillance in both developed and developing countries. Currently, the majority of POC diagnostics utilize paper substrates owing to affordability, disposability, and mass production capability. Recently, flexible polymer substrates have been investigated due to their enhanced physicochemical properties, potential to be integrated into wearable devices with wireless communications for personalized health monitoring, and ability to be customized for POC diagnostics. Here, we focus on the latest advances in developing flexible substrate-based diagnostic devices, including paper and polymers, and their clinical applications. Copyright © 2016 Elsevier Ltd. All rights reserved.

Food and Drug Administration Regulation of in Vitro Diagnostic Devices

PubMed Central

Mansfield, Elizabeth; O’Leary, Timothy J.; Gutman, Steven I.

2005-01-01

The Food and Drug Administration regulates the sale and distribution of laboratory devices under a statutory and regulatory framework that is unfamiliar to most clinical laboratory scientists. In this article we briefly describe the criteria that are used to classify and review in vitro diagnostic devices. We discuss the similarities and differences between devices that are not subject to premarket review, and those that are required to undergo either a premarket application or premarket notification [510(k)] pathway. We then discuss the methods that the Food and Drug Administration uses to assess the performance of in vitro diagnostic devices in the marketplace as a component of the total life cycle approach to medical device regulation. PMID:15681468

Initial results of the FUSION-X-US prototype combining 3D automated breast ultrasound and digital breast tomosynthesis.

PubMed

Schaefgen, Benedikt; Heil, Joerg; Barr, Richard G; Radicke, Marcus; Harcos, Aba; Gomez, Christina; Stieber, Anne; Hennigs, André; von Au, Alexandra; Spratte, Julia; Rauch, Geraldine; Rom, Joachim; Schütz, Florian; Sohn, Christof; Golatta, Michael

2018-06-01

To determine the feasibility of a prototype device combining 3D-automated breast ultrasound (ABVS) and digital breast tomosynthesis in a single device to detect and characterize breast lesions. In this prospective feasibility study, the FUSION-X-US prototype was used to perform digital breast tomosynthesis and ABVS in 23 patients with an indication for tomosynthesis based on current guidelines after clinical examination and standard imaging. The ABVS and tomosynthesis images of the prototype were interpreted separately by two blinded experts. The study compares the detection and BI-RADS® scores of breast lesions using only the tomosynthesis and ABVS data from the FUSION-X-US prototype to the results of the complete diagnostic workup. Image acquisition and processing by the prototype was fast and accurate, with some limitations in ultrasound coverage and image quality. In the diagnostic workup, 29 solid lesions (23 benign, including three cases with microcalcifications, and six malignant lesions) were identified. Using the prototype, all malignant lesions were detected and classified as malignant or suspicious by both investigators. Solid breast lesions can be localized accurately and fast by the Fusion-X-US system. Technical improvements of the ultrasound image quality and ultrasound coverage are needed to further study this new device. The prototype combines tomosynthesis and automated 3D-ultrasound (ABVS) in one device. It allows accurate detection of malignant lesions, directly correlating tomosynthesis and ABVS data. The diagnostic evaluation of the prototype-acquired data was interpreter-independent. The prototype provides a time-efficient and technically reliable diagnostic procedure. The combination of tomosynthesis and ABVS is a promising diagnostic approach.

Diagnostic accuracy of an iPhone DICOM viewer for the interpretation of magnetic resonance imaging of the knee.

PubMed

De Maio, Peter; White, Lawrence M; Bleakney, Robert; Menezes, Ravi J; Theodoropoulos, John

2014-07-01

To evaluate the diagnostic performance of viewing magnetic resonance (MR) images on a handheld mobile device compared with a conventional radiology workstation for the diagnosis of intra-articular knee pathology. Prospective comparison study. Tertiary care center. Fifty consecutive subjects who had MR imaging of the knee followed by knee arthroscopy were prospectively evaluated. Two musculoskeletal radiologists independently reviewed each MR study using 2 different viewers: the OsiriX DICOM viewer software on an Apple iPhone 3GS device and eFilm Workstation software on a conventional picture archiving and communications system workstation. Sensitivity and specificity of the iPhone and workstation interpretations was performed using knee arthroscopy as the reference standard. Intraobserver concordance and agreement between the iPhone and workstation interpretations were determined. There was no statistically significant difference between the 2 devices for each paired comparison of diagnostic performance. For the iPhone interpretations, sensitivity ranged from 77% (13 of 17) for the lateral meniscus to 100% (17 of 17) for the anterior cruciate ligament. Specificity ranged from 74% (14 of 19) for cartilage to 100% (50 of 50) for the posterior cruciate ligament. There was a very high level of interobserver and intraobserver agreement between devices and readers. The iPhone reads took longer than the corresponding workstation reads, with a significant mean difference between the iPhone and workstation reads of 3.98 minutes (P < 0.001). The diagnostic performance of interpreting MR images on a handheld mobile device for the assessment of intra-articular knee pathology is similar to that of a conventional radiology workstation, however, requires a longer viewing time. Timely and accurate interpretation of complex medical images using mobile device solutions could result in new workflow efficiencies and ultimately improve patient care.

Dichroic beamsplitter for high energy laser diagnostics

DOEpatents

LaFortune, Kai N [Livermore, CA; Hurd, Randall [Tracy, CA; Fochs, Scott N [Livermore, CA; Rotter, Mark D [San Ramon, CA; Hackel, Lloyd [Livermore, CA

2011-08-30

Wavefront control techniques are provided for the alignment and performance optimization of optical devices. A Shack-Hartmann wavefront sensor can be used to measure the wavefront distortion and a control system generates feedback error signal to optics inside the device to correct the wavefront. The system can be calibrated with a low-average-power probe laser. An optical element is provided to couple the optical device to a diagnostic/control package in a way that optimizes both the output power of the optical device and the coupling of the probe light into the diagnostics.

Intraoral fiber-optic-based diagnostic for periodontal disease

NASA Astrophysics Data System (ADS)

Colston, Bill W., Jr.; Gutierrez, Dora M.; Everett, Matthew J.; Brown, Steve B.; Langry, Kevin C.; Cox, Weldon R.; Johnson, Paul W.; Roe, Jeffrey N.

2000-05-01

The purpose of this initial study was to begin development of a new, objective diagnostic instrument that will allow simultaneous quantitation of multiple proteases within a single periodontal pocket using a chemical fiber optic senor. This approach could potentially be adapted to use specific antibodies and chemiluminescence to detect and quantitate virtually any compound and compare concentrations of different compounds within the same periodontal pocket. The device could also be used to assay secretions in salivary ducts or from a variety of wounds. The applicability is, therefore, not solely limited to dentistry and the device would be important both for clinical diagnostics and as a research too.

Radiology diagnostic devices under emergency electric power at disaster base hospitals during the acute phase of the Great East Japan Earthquake: results of a survey of all disaster base hospitals in Miyagi Prefecture.

PubMed

Maezawa, Shota; Kudo, Daisuke; Furukawa, Hajime; Nakagawa, Atsuhiro; Yamanouchi, Satoshi; Matsumura, Takashi; Egawa, Shinichi; Tominaga, Teiji; Kushimoto, Shigeki

2014-12-01

This study aimed to clarify the management of emergency electric power and the operation of radiology diagnostic devices after the Great East Japan Earthquake. Timing of electricity restoration, actual emergency electric power generation, and whether radiology diagnostic devices were operational and the reason if not were investigated through a questionnaire submitted to all 14 disaster base hospitals in Miyagi Prefecture in February and March 2013. Commercial electricity supply resumed within 3 days after the earthquake at 13 of 14 hospitals. Actual emergency electric power generation was lower than pre-disaster estimates at most of the hospitals. Only 4 of 11 hospitals were able to generate 60% of the power normally consumed. Under emergency electric power, conventional X-ray and computed tomography (CT) scanners worked in 9 of 14 (64%) and 8 of 14 (57%) hospitals, respectively. The main reason conventional X-ray and CT scanners did not operate was that hospitals had not planned to use these devices under emergency electric power. Only 2 of the 14 hospitals had a pre-disaster plan to allocate emergency electric power, and all devices operated at these 2 hospitals. Pre-disaster plans to allocate emergency electric power are required for disaster base hospitals to effectively operate radiology diagnostic devices after a disaster. (Disaster Med Public Health Preparedness. 2014;8:548-552).

Determining the Optimal Number of Core Needle Biopsy Passes for Molecular Diagnostics.

PubMed

Hoang, Nam S; Ge, Benjamin H; Pan, Lorraine Y; Ozawa, Michael G; Kong, Christina S; Louie, John D; Shah, Rajesh P

2018-03-01

The number of core biopsy passes required for adequate next-generation sequencing is impacted by needle cut, needle gauge, and the type of tissue involved. This study evaluates diagnostic adequacy of core needle lung biopsies based on number of passes and provides guidelines for other tissues based on simulated biopsies in ex vivo porcine organ tissues. The rate of diagnostic adequacy for pathology and molecular testing from lung biopsy procedures was measured for eight operators pre-implementation (September 2012-October 2013) and post-implementation (December 2013-April 2014) of a standard protocol using 20-gauge side-cut needles for ten core biopsy passes at a single academic hospital. Biopsy pass volume was then estimated in ex vivo porcine muscle, liver, and kidney using side-cut devices at 16, 18, and 20 gauge and end-cut devices at 16 and 18 gauge to estimate minimum number of passes required for adequate molecular testing. Molecular diagnostic adequacy increased from 69% (pre-implementation period) to 92% (post-implementation period) (p < 0.001) for lung biopsies. In porcine models, both 16-gauge end-cut and side-cut devices require one pass to reach the validated volume threshold to ensure 99% adequacy for molecular characterization, while 18- and 20-gauge devices require 2-5 passes depending on needle cut and tissue type. Use of 20-gauge side-cut core biopsy needles requires a significant number of passes to ensure diagnostic adequacy for molecular testing across all tissue types. To ensure diagnostic adequacy for molecular testing, 16- and 18-gauge needles require markedly fewer passes.

Recent advances in low-cost microfluidic platforms for diagnostic applications.

PubMed

Tomazelli Coltro, Wendell Karlos; Cheng, Chao-Min; Carrilho, Emanuel; de Jesus, Dosil Pereira

2014-08-01

The use of inexpensive materials and cost-effective manufacturing processes for mass production of microfluidic devices is very attractive and has spurred a variety of approaches. Such devices are particularly suited for diagnostic applications in limited resource settings. This review describes the recent and remarkable advances in the use of low-cost substrates for the development of microfluidic devices for diagnostics and clinical assays. Thus, a plethora of new and improved fabrication methods, designs, capabilities, detections, and applications of microfluidic devices fabricated with paper, plastic, and threads are covered. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Diagnostic accuracy of imaging devices in glaucoma: A meta-analysis.

PubMed

Fallon, Monica; Valero, Oliver; Pazos, Marta; Antón, Alfonso

Imaging devices such as the Heidelberg retinal tomograph-3 (HRT3), scanning laser polarimetry (GDx), and optical coherence tomography (OCT) play an important role in glaucoma diagnosis. A systematic search for evidence-based data was performed for prospective studies evaluating the diagnostic accuracy of HRT3, GDx, and OCT. The diagnostic odds ratio (DOR) was calculated. To compare the accuracy among instruments and parameters, a meta-analysis considering the hierarchical summary receiver-operating characteristic model was performed. The risk of bias was assessed using quality assessment of diagnostic accuracy studies, version 2. Studies in the context of screening programs were used for qualitative analysis. Eighty-six articles were included. The DOR values were 29.5 for OCT, 18.6 for GDx, and 13.9 for HRT. The heterogeneity analysis demonstrated statistically a significant influence of degree of damage and ethnicity. Studies analyzing patients with earlier glaucoma showed poorer results. The risk of bias was high for patient selection. Screening studies showed lower sensitivity values and similar specificity values when compared with those included in the meta-analysis. The classification capabilities of GDx, HRT, and OCT were high and similar across the 3 instruments. The highest estimated DOR was obtained with OCT. Diagnostic accuracy could be overestimated in studies including prediagnosed groups of subjects. Copyright © 2017 Elsevier Inc. All rights reserved.

Intraoral fiber optic-based diagnostic for periodontal disease

DOE Office of Scientific and Technical Information (OSTI.GOV)

Johnson, P W; Gutierrez, D M; Everett, M J

2000-01-21

The purpose of this initial study was to begin development of a new, objective diagnostic instrument that will allow simultaneous quantitation of multiple proteases within a single periodontal pocket using a chemical fiber optic sensor. This approach could potentially be adapted to use specific antibodies and chemiluminescence to detect and quantitate virtually any compound and compare concentrations of different compounds within the same periodontal pocket. The device could also be used to assay secretions in salivary ducts or from a variety of wounds. The applicability is, therefore, not solely limited to dentistry and the device would be important both formore » clinical diagnostics and as a research tool.« less

Measuring time of flight of fusion products in an inertial electrostatic confinement fusion device for spatial profiling of fusion reactions

DOE Office of Scientific and Technical Information (OSTI.GOV)

Donovan, D. C.; Boris, D. R.; Kulcinski, G. L.

2013-03-15

A new diagnostic has been developed that uses the time of flight (TOF) of the products from a nuclear fusion reaction to determine the location where the fusion reaction occurred. The TOF diagnostic uses charged particle detectors on opposing sides of the inertial electrostatic confinement (IEC) device that are coupled to high resolution timing electronics to measure the spatial profile of fusion reactions occurring between the two charged particle detectors. This diagnostic was constructed and tested by the University of Wisconsin-Madison Inertial Electrostatic Confinement Fusion Group in the IEC device, HOMER, which accelerates deuterium ions to fusion relevant energies inmore » a high voltage ({approx}100 kV), spherically symmetric, electrostatic potential well [J. F. Santarius, G. L. Kulcinski, R. P. Ashley, D. R. Boris, B. B. Cipiti, S. K. Murali, G. R. Piefer, R. F. Radel, T. E. Radel, and A. L. Wehmeyer, Fusion Sci. Technol. 47, 1238 (2005)]. The TOF diagnostic detects the products of D(d,p)T reactions and determines where along a chord through the device the fusion event occurred. The diagnostic is also capable of using charged particle spectroscopy to determine the Doppler shift imparted to the fusion products by the center of mass energy of the fusion reactants. The TOF diagnostic is thus able to collect spatial profiles of the fusion reaction density along a chord through the device, coupled with the center of mass energy of the reactions occurring at each location. This provides levels of diagnostic detail never before achieved on an IEC device.« less

Optical coherence tomography for glaucoma diagnosis: An evidence based meta-analysis

PubMed Central

Armstrong, James J.; Pintwala, Robert; Hutnik, Cindy

2018-01-01

Purpose Early detection, monitoring and understanding of changes in the retina are central to the diagnosis of glaucomatous optic neuropathy, and vital to reduce visual loss from this progressive condition. The main objective of this investigation was to compare glaucoma diagnostic accuracy of commercially available optical coherence tomography (OCT) devices (Zeiss Stratus, Zeiss Cirrus, Heidelberg Spectralis and Optovue RTVue, and Topcon 3D-OCT). Patients 16,104 glaucomatous and 11,543 normal eyes reported in 150 studies. Methods Between Jan. 2017 and Feb 2017, MEDLINE®, EMBASE®, CINAHL®, Cochrane Library®, Web of Science®, and BIOSIS® were searched for studies assessing glaucoma diagnostic accuracy of the aforementioned OCT devices. Meta-analysis was performed pooling area under the receiver operating characteristic curve (AUROC) estimates for all devices, stratified by OCT type (RNFL, macula), and area imaged. Results 150 studies with 16,104 glaucomatous and 11,543 normal control eyes were included. Key findings: AUROC of glaucoma diagnosis for RNFL average for all glaucoma patients was 0.897 (0.887–0.906, n = 16,782 patient eyes), for macula ganglion cell complex (GCC) was 0.885 (0.869–0.901, n = 4841 eyes), for macula ganglion cell inner plexiform layer (GCIPL) was 0.858 (0.835–0.880, n = 4211 eyes), and for total macular thickness was 0.795 (0.754–0.834, n = 1063 eyes). Conclusion The classification capability was similar across all 5 OCT devices. More diagnostically favorable AUROCs were demonstrated in patients with increased glaucoma severity. Diagnostic accuracy of RNFL and segmented macular regions (GCIPL, GCC) scans were similar and higher than total macular thickness. This study provides a synthesis of contemporary evidence with features of robust inclusion criteria and large sample size. These findings may provide guidance to clinicians when navigating this rapidly evolving diagnostic area characterized by numerous options. PMID:29300765

Laser machined plastic laminates. Towards portable diagnostic devices for use in low resource environments

DOE PAGES

Harper, Jason C.; Carson, Bryan D.; Bachand, George D.; ...

2015-07-14

Despite significant progress in development of bioanalytical devices cost, complexity, access to reagents and lack of infrastructure have prevented use of these technologies in resource-limited regions. To provide a sustainable tool in the global effort to combat infectious diseases the diagnostic device must be low cost, simple to operate and read, robust, and have sensitivity and specificity comparable to laboratory analysis. Thus, in this mini-review we describe recent work using laser machined plastic laminates to produce diagnostic devices that are capable of a wide variety of bioanalytical measurements and show great promise towards future use in low-resource environments.

Enhancing the Usability of an Optical Reader System to Support Point-of-Care Rapid Diagnostic Testing: An Iterative Design Approach.

PubMed

Hohenstein, Jess; O'Dell, Dakota; Murnane, Elizabeth L; Lu, Zhengda; Erickson, David; Gay, Geri

2017-11-21

In today's health care environment, increasing costs and inadequate medical resources have created a worldwide need for more affordable diagnostic tools that are also portable, fast, and easy to use. To address this issue, numerous research and commercial efforts have focused on developing rapid diagnostic technologies; however, the efficacy of existing systems has been hindered by usability problems or high production costs, making them infeasible for deployment in at-home, point-of-care (POC), or resource-limited settings. The aim of this study was to create a low-cost optical reader system that integrates with any smart device and accepts any type of rapid diagnostic test strip to provide fast and accurate data collection, sample analysis, and diagnostic result reporting. An iterative design methodology was employed by a multidisciplinary research team to engineer three versions of a portable diagnostic testing device that were evaluated for usability and overall user receptivity. Repeated design critiques and usability studies identified a number of system requirements and considerations (eg, software compatibility, biomatter contamination, and physical footprint) that we worked to incrementally incorporate into successive system variants. Our final design phase culminated in the development of Tidbit, a reader that is compatible with any Wi-Fi-enabled device and test strip format. The Tidbit includes various features that support intuitive operation, including a straightforward test strip insertion point, external indicator lights, concealed electronic components, and an asymmetric shape, which inherently signals correct device orientation. Usability testing of the Tidbit indicates high usability for potential user communities. This study presents the design process, specification, and user reception of the Tidbit, an inexpensive, easy-to-use, portable optical reader for fast, accurate quantification of rapid diagnostic test results. Usability testing suggests that the reader is usable among and can benefit a wide group of potential users, including in POC contexts. Generally, the methodology of this study demonstrates the importance of testing these types of systems with potential users and exemplifies how iterative design processes can be employed by multidisciplinary research teams to produce compelling technological solutions. ©Jess Hohenstein, Dakota O'Dell, Elizabeth L Murnane, Zhengda Lu, David Erickson, Geri Gay. Originally published in JMIR Human Factors (http://humanfactors.jmir.org), 21.11.2017.

A semi-automated, field-portable microscopy platform for clinical diagnostic applications

NASA Astrophysics Data System (ADS)

Jagannadh, Veerendra Kalyan; Srinivasan, Rajesh; Gorthi, Sai Siva

2015-08-01

Clinical microscopy is a versatile diagnostic platform used for diagnosis of a multitude of diseases. In the recent past, many microfluidics based point-of-care diagnostic devices have been developed, which serve as alternatives to microscopy. However, these point-of-care devices are not as multi-functional and versatile as clinical microscopy. With the use of custom designed optics and microfluidics, we have developed a versatile microscopy-based cellular diagnostic platform, which can be used at the point of care. The microscopy platform presented here is capable of detecting infections of very low parasitemia level (in a very small quantity of sample), without the use of any additional computational hardware. Such a cost-effective and portable diagnostic device, would greatly impact the quality of health care available to people living in rural locations of the world. Apart from clinical diagnostics, it's applicability to field research in environmental microbiology has also been outlined.

ICNIRP Statement on Diagnostic Devices Using Non-ionizing Radiation: Existing Regulations and Potential Health Risks.

PubMed

2017-03-01

Use of non-ionizing radiation (NIR) for diagnostic purposes allows non-invasive assessment of the structure and function of the human body and is widely employed in medical care. ICNIRP has published previous statements about the protection of patients during medical magnetic resonance imaging (MRI), but diagnostic methods using other forms of NIR have not been considered. This statement reviews the range of diagnostic NIR devices currently used in clinical settings; documents the relevant regulations and policies covering patients and health care workers; reviews the evidence around potential health risks to patients and health care workers exposed to diagnostic NIR; and identifies situations of high NIR exposure from diagnostic devices in which patients or health care workers might not be adequately protected by current regulations. Diagnostic technologies were classified by the types of NIR that they employ. The aim was to describe the techniques in terms of general device categories which may encompass more specific devices or techniques with similar scientific principles. Relevant legally-binding regulations for protection of patients and workers and organizations responsible for those regulations were summarized. Review of the epidemiological evidence concerning health risks associated with exposure to diagnostic NIR highlighted a lack of data on potential risks to the fetus exposed to MRI during the first trimester, and on long-term health risks in workers exposed to MRI. Most of the relevant epidemiological evidence that is currently available relates to MRI or ultrasound. Exposure limits are needed for exposures from diagnostic technologies using optical radiation within the body. There is a lack of data regarding risk of congenital malformations following exposure to ultrasound in utero in the first trimester and also about the possible health effects of interactions between ultrasound and contrast media.

ICNIRP Statement on Diagnostic Devices Using Non-ionizing Radiation: Existing Regulations and Potential Health Risks

PubMed Central

2017-01-01

Abstract Use of non-ionizing radiation (NIR) for diagnostic purposes allows non-invasive assessment of the structure and function of the human body and is widely employed in medical care. ICNIRP has published previous statements about the protection of patients during medical magnetic resonance imaging (MRI), but diagnostic methods using other forms of NIR have not been considered. This statement reviews the range of diagnostic NIR devices currently used in clinical settings; documents the relevant regulations and policies covering patients and health care workers; reviews the evidence around potential health risks to patients and health care workers exposed to diagnostic NIR; and identifies situations of high NIR exposure from diagnostic devices in which patients or health care workers might not be adequately protected by current regulations. Diagnostic technologies were classified by the types of NIR that they employ. The aim was to describe the techniques in terms of general device categories which may encompass more specific devices or techniques with similar scientific principles. Relevant legally-binding regulations for protection of patients and workers and organizations responsible for those regulations were summarized. Review of the epidemiological evidence concerning health risks associated with exposure to diagnostic NIR highlighted a lack of data on potential risks to the fetus exposed to MRI during the first trimester, and on long-term health risks in workers exposed to MRI. Most of the relevant epidemiological evidence that is currently available relates to MRI or ultrasound. Exposure limits are needed for exposures from diagnostic technologies using optical radiation within the body. There is a lack of data regarding risk of congenital malformations following exposure to ultrasound in utero in the first trimester and also about the possible health effects of interactions between ultrasound and contrast media. PMID:28121732

An eight-year prospective controlled study about the safety and diagnostic value of cardiac and non-cardiac 1.5-T MRI in patients with a conventional pacemaker or a conventional implantable cardioverter defibrillator.

PubMed

Lupo, Pierpaolo; Cappato, Riccardo; Di Leo, Giovanni; Secchi, Francesco; Papini, Giacomo D E; Foresti, Sara; Ali, Hussam; De Ambroggi, Guido M G; Sorgente, Antonio; Epicoco, Gianluca; Cannaò, Paola M; Sardanelli, Francesco

2018-06-01

To investigate safety and diagnostic value of 1.5-T MRI in carriers of conventional pacemaker (cPM) or conventional implantable defibrillator (cICD). We prospectively compared cPM/cICD-carriers undergoing MRI (study group, SG), excluding those device-dependent or implanted <6 weeks before enrolment or prior to 01/01/2000, with cPM/cICD-carriers undergoing chest x-ray, CT or follow-up (reference group, RG). 142 MRI (55 cardiac) were performed in 120 patients with cPM (n=71) or cICD (n=71). In the RG 98 measurements were performed in 95 patients with cPM (n=40) or cICD (n=58). No adverse events were observed. No MRI prolonged/interrupted. All cPM/cICD were correctly reprogrammed after MRI without malfunctions. One temporary communication failure was observed in one cPM-carrier. Immediately after MRI, 12/14 device interrogation parameters did not change significantly (clinically negligible changes of battery voltage and cICD charging time), without significant variations for SG versus RG. Three-12 months after MRI, 9/11 device interrogation parameters did not change significantly (clinically negligible changes of battery impedance/voltage). Non-significant changes of three markers of myocardial necrosis. Non-cardiac MRI: 82/87 diagnostic without artefacts; 4/87 diagnostic with artefacts; 1/87 partially diagnostic. Cardiac MRI: in cPM-carriers, 14/15 diagnostic with artefacts, 1/15 partially diagnostic; in cICD-carriers, 9/40 diagnostic with artefacts, 22 partially diagnostic, nine non-diagnostic. A favourable risk-benefit ratio of 1.5-T MRI in cPM/cICD carriers was reported. • Cooperation between radiologists and cardiac electrophysiologists allowed safe 1.5-T MRI in cPM/cICD-carriers. • No adverse events for 142 MRI in 71 cPM-carriers and 71 cICD-carriers. • Ninety-nine per cent (86/87) of non-cardiac MRI in cPM/cICD-carriers were diagnostic. • All cPM-carrier cardiac MRIs had artefacts, 14 examinations diagnostic, 1 partially diagnostic. • Twenty-three per cent (9/40) of cardiac MRI in cICD-carriers were non-diagnostic.

Paper-based sample-to-answer molecular diagnostic platform for point-of-care diagnostics.

PubMed

Choi, Jane Ru; Tang, Ruihua; Wang, ShuQi; Wan Abas, Wan Abu Bakar; Pingguan-Murphy, Belinda; Xu, Feng

2015-12-15

Nucleic acid testing (NAT), as a molecular diagnostic technique, including nucleic acid extraction, amplification and detection, plays a fundamental role in medical diagnosis for timely medical treatment. However, current NAT technologies require relatively high-end instrumentation, skilled personnel, and are time-consuming. These drawbacks mean conventional NAT becomes impractical in many resource-limited disease-endemic settings, leading to an urgent need to develop a fast and portable NAT diagnostic tool. Paper-based devices are typically robust, cost-effective and user-friendly, holding a great potential for NAT at the point of care. In view of the escalating demand for the low cost diagnostic devices, we highlight the beneficial use of paper as a platform for NAT, the current state of its development, and the existing challenges preventing its widespread use. We suggest a strategy involving integrating all three steps of NAT into one single paper-based sample-to-answer diagnostic device for rapid medical diagnostics in the near future. Copyright © 2015 Elsevier B.V. All rights reserved.

The path to exploring physics in advanced devices with a heavy ion beam probe

NASA Astrophysics Data System (ADS)

Demers, D. R.; Fimognari, P. J.

2012-10-01

The scientific progression of alternative or advanced devices must be met with comparable diagnostic technologies. Heavy ion beam probe innovations from ongoing diagnostic development are meeting this challenge. The diagnostic is uniquely capable of measuring the radial electric field, critically important in stellarators, simultaneously with fluctuations of electron density and electric potential. HIBP measurements can also improve the understanding of edge physics in tokamaks and spherical tori. It can target issues associated with the pedestal region, including the mechanisms underlying the L-H transition, the onset and evolution of ELMs, and the evolution of the electron current density. Beam attenuation (and resulting low signal to noise levels), a challenge to operation on devices with large plasma cross-sections and high ne and Te, can be mitigated with greater beam energies and currents. Other application challenges, such as measurements of plasma fluctuations and profile variations with elevated temporal and spatial resolutions, can be achieved with innovative detectors. The scientific studies motivating the implementation of an HIBP on HSX, ASDEX-U, and W7-X will be presented along with preliminary scoping studies.

The video fluorescent device for diagnostics of cancer of human reproductive system

NASA Astrophysics Data System (ADS)

Brysin, Nickolay N.; Linkov, Kirill G.; Stratonnikov, Alexander A.; Savelieva, Tatiana A.; Loschenov, Victor B.

2008-06-01

Photodynamic therapy (PDT) is one of the advanced methods of treatment of skin cancer and surfaces of internal organs. The basic advantages of PDT are high efficiency and low cost of treatment. PDT technique is needed for providing fluorescent diagnostics. Laser-based systems are widely applied to the fluorescence excitations for diagnostic because of a narrow spectrum of fluorescence excitation and high density of radiation. Application of laser systems for carrying out fluorescent diagnostics gives the image of a tumor distorted by speckles that does not give an opportunity to obtain full information about the form of a tumor quickly. Besides, these laser excitation systems have complicated structure and high cost. As a base for the development and creation of a video fluorescent device one of commercially produced colposcopes was chosen. It allows to decrease cost of the device, and also has enabled to make modernization for already used colposcopes. A LED-based light source was offered to be used for fluorescence excitation in this work. The maximum in a spectrum of radiation of LEDs corresponds to the general spectral maximum of protoporphyrin IX (PPIX) absorption. Irradiance in the center of a light spot is 31 mW/cm2. The receiving optical system of the fluorescent channel is adjusted at 635 nm where a general spectral maximum of fluorescence PPIX is located. Also the device contains a RGB video channel, a white light source and a USB spectrometer LESA-01-BIOSPEC, for measurement of spectra of fluorescence and diffusion reflections in treatment area. The software is developed for maintenance of the device. Some studies on laboratory animals were made. As a result, areas with the increased concentration of a PPIX were correctly detected. At present, the device is used for diagnostics of cancer of female reproductive system in Research Centre for Obstetrics, Gynecology and Perinatology of the Russian Academy of Medical Sciences (Moscow, Russia).

Radiological Medical Device Innovation: Approvals via the Premarket Approval Pathway From 2000 to 2015.

PubMed

Ghobadi, Comeron W; Hayman, Emily L; Finkle, Joshua H; Walter, Jessica R; Xu, Shuai

2017-01-01

The aim of this study was to critically assess the clinical evidence leading to radiologic medical device approvals via the premarket approval pathway from 2000 to 2015. This study used the publically available FDA premarket database for radiologic device approvals over the past 15 years (September 1, 2000, to August 31, 2015). Approval characteristics were collected for each device, and statistical analysis was performed on the data for each pivotal trial. Additionally, methodological quality of the pivotal trial was determined using the Quality Assessment of Diagnostic Accuracy Studies tool. Twenty-three class III radiologic device approvals were identified, with breast imaging accounting for 16 (70%) and computer-aided detection software accounting for 9 (39%) approvals. The median premarket approval time was 475 days (range, 180-1,116). Twenty-one devices were approved on the basis of multireader, multicenter studies, one on the basis of a randomized controlled trial, and one on the basis of a preclinical technical equivalence trial. The median number of patients per pivotal trial was 201 (range, 25-3,946). Twenty-six of the 34 pivotal trials (76%) had at least one methodologic bias. Breast imaging devices had a greater number of patients per pivotal trial (P = .009) and more prospective studies. With regard to all modalities, increased time to device approval correlated with weaker trial quality (r = 0.600, P < .001). Radiologic devices are largely approved by multireader, multicenter studies, the recommended standard for assessing diagnostic technologies. Given that radiologic devices play a key role in modern medicine, further efforts should be made to increase transparency of clinical data leading to approval. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

21 CFR 872.2060 - Jaw tracking device.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.2060 Jaw tracking device. (a) Jaw tracking device... Controls Guidance Document: Dental Sonography and Jaw Tracking Devices.” [68 FR 67367, Dec. 2, 2003] ...

Laboratory development and testing of spacecraft diagnostics

NASA Astrophysics Data System (ADS)

Amatucci, William; Tejero, Erik; Blackwell, Dave; Walker, Dave; Gatling, George; Enloe, Lon; Gillman, Eric

2017-10-01

The Naval Research Laboratory's Space Chamber experiment is a large-scale laboratory device dedicated to the creation of large-volume plasmas with parameters scaled to realistic space plasmas. Such devices make valuable contributions to the investigation of space plasma phenomena under controlled, reproducible conditions, allowing for the validation of theoretical models being applied to space data. However, in addition to investigations such as plasma wave and instability studies, such devices can also make valuable contributions to the development and testing of space plasma diagnostics. One example is the plasma impedance probe developed at NRL. Originally developed as a laboratory diagnostic, the sensor has now been flown on a sounding rocket, is included on a CubeSat experiment, and will be included on the DoD Space Test Program's STP-H6 experiment on the International Space Station. In this talk, we will describe how the laboratory simulation of space plasmas made this development path possible. Work sponsored by the US Naval Research Laboratory Base Program.

Smartphone-Based Fluorescent Diagnostic System for Highly Pathogenic H5N1 Viruses.

PubMed

Yeo, Seon-Ju; Choi, Kyunghan; Cuc, Bui Thi; Hong, Nguyen Ngoc; Bao, Duong Tuan; Ngoc, Nguyen Minh; Le, Mai Quynh; Hang, Nguyen Le Khanh; Thach, Nguyen Co; Mallik, Shyam Kumar; Kim, Hak Sung; Chong, Chom-Kyu; Choi, Hak Soo; Sung, Haan Woo; Yu, Kyoungsik; Park, Hyun

2016-01-01

Field diagnostic tools for avian influenza (AI) are indispensable for the prevention and controlled management of highly pathogenic AI-related diseases. More accurate, faster and networked on-site monitoring is demanded to detect such AI viruses with high sensitivity as well as to maintain up-to-date information about their geographical transmission. In this work, we assessed the clinical and field-level performance of a smartphone-based fluorescent diagnostic device with an efficient reflective light collection module using a coumarin-derived dendrimer-based fluorescent lateral flow immunoassay. By application of an optimized bioconjugate, a smartphone-based diagnostic device had a two-fold higher detectability as compared to that of the table-top fluorescence strip reader for three different AI subtypes (H5N3, H7N1, and H9N2). Additionally, in a clinical study of H5N1-confirmed patients, the smartphone-based diagnostic device showed a sensitivity of 96.55% (28/29) [95% confidence interval (CI): 82.24 to 99.91] and a specificity of 98.55% (68/69) (95% CI: 92.19 to 99.96). The measurement results from the distributed individual smartphones were wirelessly transmitted via short messaging service and collected by a centralized database system for further information processing and data mining. Smartphone-based diagnosis provided highly sensitive measurement results for H5N1 detection within 15 minutes. Because of its high sensitivity, portability and automatic reporting feature, the proposed device will enable agile identification of patients and efficient control of AI dissemination.

Smartphone-Based Fluorescent Diagnostic System for Highly Pathogenic H5N1 Viruses

PubMed Central

Yeo, Seon-Ju; Choi, Kyunghan; Cuc, Bui Thi; Hong, Nguyen Ngoc; Bao, Duong Tuan; Ngoc, Nguyen Minh; Le, Mai Quynh; Hang, Nguyen Le Khanh; Thach, Nguyen Co; Mallik, Shyam Kumar; Kim, Hak Sung; Chong, Chom-Kyu; Choi, Hak Soo; Sung, Haan Woo; Yu, Kyoungsik; Park, Hyun

2016-01-01

Field diagnostic tools for avian influenza (AI) are indispensable for the prevention and controlled management of highly pathogenic AI-related diseases. More accurate, faster and networked on-site monitoring is demanded to detect such AI viruses with high sensitivity as well as to maintain up-to-date information about their geographical transmission. In this work, we assessed the clinical and field-level performance of a smartphone-based fluorescent diagnostic device with an efficient reflective light collection module using a coumarin-derived dendrimer-based fluorescent lateral flow immunoassay. By application of an optimized bioconjugate, a smartphone-based diagnostic device had a two-fold higher detectability as compared to that of the table-top fluorescence strip reader for three different AI subtypes (H5N3, H7N1, and H9N2). Additionally, in a clinical study of H5N1-confirmed patients, the smartphone-based diagnostic device showed a sensitivity of 96.55% (28/29) [95% confidence interval (CI): 82.24 to 99.91] and a specificity of 98.55% (68/69) (95% CI: 92.19 to 99.96). The measurement results from the distributed individual smartphones were wirelessly transmitted via short messaging service and collected by a centralized database system for further information processing and data mining. Smartphone-based diagnosis provided highly sensitive measurement results for H5N1 detection within 15 minutes. Because of its high sensitivity, portability and automatic reporting feature, the proposed device will enable agile identification of patients and efficient control of AI dissemination. PMID:26877781

Patch testers' opinions regarding diagnostic criteria for metal hypersensitivity reactions to metallic implants.

PubMed

Schalock, Peter C; Thyssen, Jacob P

2013-01-01

Metal hypersensitivity reactions to implanted devices remain a challenging and controversial topic. Diagnostic criteria and methods are not well delineated. Diagnostic criteria for hypersensitivity reactions after metallic device implantation are evaluated in this study by a multinational group of patch testers using Thyssen's previously published criteria. A total of 119 dermatologists at the 2012 European Contact Dermatitis Society and 2013 American Contact Dermatitis Society meetings answered a survey regarding their opinions on topics relating to metal hypersensitivity. Four major and 5 minor diagnostic criteria emerged. Approximately 80% of respondents found the following criteria useful (major criteria): chronic dermatitis beginning weeks to months after metallic implantation, eruption overlying the metal implant, positive patch test to a metal component of the implant, and complete clearing after removal of the potentially allergenic implant. Minor criteria (<61% of respondents) were as follows: systemic allergic dermatitis reaction, therapy-resistant dermatitis, morphology consistent with dermatitis, histology consistent with allergic contact dermatitis, and a positive in vitro test to metals (eg, lymphocyte transformation test). In the challenging situation such as a symptomatic or failing orthopedic device, applying these 4 major criteria and the 5 supportive minor criteria may be useful for guiding decision making.

A pilot study using laser-based technique for non-invasive diagnostics of hypertensive conditions in mice

NASA Astrophysics Data System (ADS)

Litvinova, Karina S.; Ahmad, Shakil; Wang, Keqing; Rafailov, Ilya E.; Sokolovski, Sergei G.; Zhang, Lin; Rafailov, Edik U.; Ahmed, Asif

2016-02-01

Endothelial dysfunction is directly linked to preeclampsia, a maternal hypertensive condition that is life threating for both the mother and the baby. Epidemiological studies show that women with a history of pre-eclampsia have an elevated risk for cardiovascular disease. Here we report a new non-invasive diagnostic test for preeclampsia in mice that allows us to non-invasively assess the condition of the animals during the experiment and treatment in established models of preeclampsia. A laser-based multifunctional diagnostics system (LAKK-M) was chosen to carry out non-invasive analysis of multiple parameters. The device was used to simultaneously record the microcirculatory blood flow and oxygen saturation, as well as fluorescence levels of endogenous fluorophores. Preliminary experiments were conducted on adenoviral (Ad-)- mediated overexpression of sFlt-1 (Ad-sFlt-1) to mimic preeclampsialike symptoms in mice. The recorded data displayed the ability of the LAKK-M diagnostics device to detect significant differences in perfusion measurements between the control and Ad-sFlt-1 treatment. Preliminary results provide a potential avenue to employ these diagnostics technology to monitor and aid in maintaining control of live animal conditions throughout the experiment and treatment.

Miniaturized devices towards an integrated lab-on-a-chip platform for DNA diagnostics

NASA Astrophysics Data System (ADS)

Kaprou, G.; Papadakis, G.; Kokkoris, G.; Papadopoulos, V.; Kefala, I.; Papageorgiou, D.; Gizeli, E.; Tserepi, A.

2015-06-01

Microfluidics is an emerging technology enabling the development of Lab-on-a-chip (LOC) systems for clinical diagnostics, drug discovery and screening, food safety and environmental analysis. LOC systems integrate and scale down one or several laboratory functions on a single chip of a few mm2 to cm2 in size, and account for many advantages on biochemical analyses, such as low sample and reagent consumption, low cost, reduced analysis time, portability and point-of-need compatibility. Currently, available nucleic acid diagnostic tests take advantage of Polymerase Chain Reaction (PCR) that allows exponential amplification of portions of nucleic acid sequences that can be used as indicators for the identification of various diseases. Here, we present a comparison between static chamber and continuous flow miniaturized PCR devices, in terms of energy consumption for devices fabricated on the same material stack, with identical sample volume and channel dimensions. The comparison is implemented by a computational study coupling heat transfer in both solid and fluid, mass conservation of species, and joule heating. Based on the conclusions of this study, we develop low-cost and fast DNA amplification devices for both PCR and isothermal amplification, and we implement them in the detection of mutations related to breast cancer. The devices are fabricated by mass production amenable technologies on printed circuit board (PCB) substrates, where copper facilitates the incorporation of on-chip microheaters, defining the thermal zones necessary for PCR or isothermal amplification methods.

Computerized screening devices and performance assessment: development of a policy towards automation. International Academy of Cytology Task Force summary. Diagnostic Cytology Towards the 21st Century: An International Expert Conference and Tutorial.

PubMed

Bartels, P H; Bibbo, M; Hutchinson, M L; Gahm, T; Grohs, H K; Gwi-Mak, E; Kaufman, E A; Kaufman, R H; Knight, B K; Koss, L G; Magruder, L E; Mango, L J; McCallum, S M; Melamed, M R; Peebles, A; Richart, R M; Robinowitz, M; Rosenthal, D L; Sauer, T; Schenck, U; Tanaka, N; Topalidis, T; Verhest, A P; Wertlake, P T; Wilbur, D C

1998-01-01

The extension of automation to the diagnostic assessment of clinical materials raises issues of professional responsibility, on the part of both the medical professional and designer of the device. The International Academy of Cytology (IAC) and other professional cytology societies should develop a policy towards automation in the diagnostic assessment of clinical cytologic materials. The following summarizes the discussion of the initial position statement at the International Expert Conference on Diagnostic Cytology Towards the 21st Century, Hawaii, June 1997. 1. The professional in charge of a clinical cytopathology laboratory continues to bear the ultimate medical responsibility for diagnostic decisions made at the facility, whether automated devices are involved or not. 2. The introduction of automated procedures into clinical cytology should under no circumstances lead to a lowering of standards of performance. A prime objective of any guidelines should be to ensure that an automated procedure, in principle, does not expose any patient to new risks, nor should it increase already-existing, inherent risks. 3. Automated devices should provide capabilities for the medical professional to conduct periodic tests of the appropriate performance of the device. 4. Supervisory personnel should continue visual quality control screening of a certain percentage of slides dismissed at primary screening as within normal limits (WNL), even when automated procedures are employed in the laboratory. 5. Specifications for the design of primary screening devices for the detection of cervical cancer issued by the IAC in 1984 were reaffirmed. 6. The setting of numeric performance criteria is the proper charge of regulatory agencies, which also have the power of enforcement. 7. Human expert verification of results represents the "gold standard" at this time. Performance characteristics of computerized cytology devices should be determined by adherence to defined and well-considered protocols. Manufacturers should not claim a new standard of care; this is the responsibility of the medical community and professional groups. 8. Cytology professionals should support the development of procedures that bring about an improvement in diagnostic decision making. Advances in technology should be adopted if they can help solve problems in clinical cytology. The introduction of automated procedures into diagnostic decision making should take place strictly under the supervision and with the active participation and critical evaluation by the professional cytology community. Guidelines should be developed for the communication of technical information about the performance of automated screening devices by the IAC to governmental agencies and national societies. Also, guidelines are necessary for the official communication of IAC concerns to industry, medicolegal entities and the media. Procedures and guidelines for the evaluation of studies pertaining to the performance of automated devices, performance metrics and definitions for evaluation criteria should be established.

A diagnostic expert system for aircraft generator control unit (GCU)

NASA Astrophysics Data System (ADS)

Ho, Ting-Long; Bayles, Robert A.; Havlicsek, Bruce L.

The modular VSCF (variable-speed constant-frequency) generator families are described as using standard modules to reduce the maintenance cost and to improve the product's testability. A general diagnostic expert system shell that guides troubleshooting of modules or line replaceable units (LRUs) is introduced. An application of the diagnostic system to a particular LRU, the generator control unit (GCU) is reported. The approach to building the diagnostic expert system is first to capture general diagnostic strategy in an expert system shell. This shell can be easily applied to different devices or LRUs by writing rules to capture only additional device-specific diagnostic information from expert repair personnel. The diagnostic system has the necessary knowledge embedded in its programs and exhibits expertise to troubleshoot the GCU.

Power accounting of plasma discharges in the linear device Proto-MPEX

NASA Astrophysics Data System (ADS)

Showers, M.; Piotrowicz, P. A.; Beers, C. J.; Biewer, T. M.; Caneses, J.; Canik, J.; Caughman, J. B. O.; Donovan, D. C.; Goulding, R. H.; Lumsdaine, A.; Kafle, N.; Owen, L. W.; Rapp, J.; Ray, H.

2018-06-01

Plasma material interaction (PMI) studies are crucial to the successful development of future fusion reactors. Prototype Material Plasma Exposure eXperiment (Proto-MPEX) is a prototype design for the MPEX, a steady-state linear device being developed to study PMI. The primary purpose of Proto-MPEX is developing the plasma heating source concepts for MPEX. A power accounting study of Proto-MPEX works to identify machine operating parameters that could improve its performance, thereby increasing its PMI research capabilities, potentially impacting the MPEX design concept. To build a comprehensive power balance, an analysis of the helicon region has been performed implementing a diagnostic suite and software modeling to identify mechanisms and locations of heat loss from the main plasma. Of the 106.3 kW of input power, up to 90.5% of the power has been accounted for in the helicon region. When the analysis was extended to encompass the device to its end plates, 49.2% of the input power was accounted for and verified diagnostically. Areas requiring further diagnostic analysis are identified. The required improvements will be implemented in future work. The data acquisition and analysis processes will be streamlined to form a working model for future power balance studies of Proto-MPEX. ).

75 FR 36425 - Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Studies...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-25

..., International, and Consumer Assistance, Center for Devices and Radiological Health (CDRH), Food and Drug...-addressed adhesive label to assist that office in processing your request, or fax your request to CDRH at... IVD studies. CDRH and CBER both have regulatory oversight of IVD devices. Information in this guidance...

Blister pouches for effective reagent storage and release for low cost point-of-care diagnostic applications

NASA Astrophysics Data System (ADS)

Smith, Suzanne; Sewart, Rene; Land, Kevin; Roux, Pieter; Gärtner, Claudia; Becker, Holger

2016-03-01

Lab-on-a-chip devices are often applied to point-of-care diagnostic solutions as they are low-cost, compact, disposable, and require only small sample volumes. For such devices, various reagents are required for sample preparation and analysis and, for an integrated solution to be realized, on-chip reagent storage and automated introduction are required. This work describes the implementation and characterization of effective liquid reagent storage and release mechanisms utilizing blister pouches applied to various point-of-care diagnostic device applications. The manufacturing aspects as well as performance parameters are evaluated.

Photovoltaic test and demonstration project. [residential energy program

NASA Technical Reports Server (NTRS)

Forestieri, A. F.; Brandhorst, H. W., Jr.; Deyo, J. N.

1976-01-01

The considered project consists of three subprojects related to applications, device performance and diagnostics, and endurance testing. The objectives of the applications subproject include the determination of the operating characteristics for a variety of photovoltaic conversion systems. A system test facility is being constructed in this connection and a prototype residence experiment is to be conducted. Market demand for solar cells is to be stimulated by demonstrating suitability of solar cells for specific near-term applications. Activities conducted in connection with device performance studies and diagnostics are also discussed along with developments in the area of endurance testing.

SPEAR Trial: Smartphone Pediatric ElectrocARdiogram Trial

PubMed Central

Nguyen, Hoang H.; Van Hare, George F.; Rudokas, Michael; Bowman, Tammy; Silva, Jennifer N. A.

2015-01-01

Objectives Smartphone-enabled ECG devices have the potential to improve patient care by enabling remote ECG assessment of patients with potential and diagnosed arrhythmias. This prospective study aimed to assess the usefulness of pediatric ECG tracings generated by the AliveCor device (Oklahoma City, OK) and to assess user satisfaction. Study Design Enrolled pediatric patients with documented paroxysmal arrhythmia used the AliveCor device over a yearlong study period. Pediatric electrophysiologists reviewed all transmitted ECG tracings. Patient completed surveys were analyzed to assess user satisfaction. Results 35 patients were enrolled with the following diagnoses: supraventricular tachycardia (SVT, 57%), atrial fibrillation (AF, 11%), ectopic atrial tachycardia (EAT, 6%), atrial tachycardia (AT, 3%), and ventricular tachycardia (VT, 23%). A total of 238 tracings were received from 20 patients, 96% of which were of diagnostic quality for sinus rhythm, sinus tachycardia, SVT, and AF. 126 patient satisfaction surveys (64% from parents) were completed. 98% of the survey responses indicated that it was easy to obtain tracings, 93% found it easy to transmit the tracings, 98% showed added comfort in managing arrhythmia by having the device, and 93% showed interest in continued use of the device after the study period ended. Conclusions Smartphone-enabled ECG devices can generate tracings of diagnostic quality in children. User satisfaction was extremely positive. Use of the device to manage certain patients with AF and SVT showcases the future role of remote ECGs in the successful outpatient management of arrhythmias in children by potentially reducing Emergency Department visits and healthcare costs. PMID:26295569

In-vivo orthopedic implant diagnostic device for sensing load, wear, and infection

DOEpatents

Evans, III, Boyd McCutchen; Thundat, Thomas G.; Komistek, Richard D.; Dennis, Douglas A.; Mahfouz, Mohamed

2006-08-29

A device for providing in vivo diagnostics of loads, wear, and infection in orthopedic implants having at least one load sensor associated with the implant, at least one temperature sensor associated with the implant, at least one vibration sensor associated with the implant, and at least one signal processing device operatively coupled with the sensors. The signal processing device is operable to receive the output signal from the sensors and transmit a signal corresponding with the output signal.

Microfluidics and Coagulation Biology

PubMed Central

Colace, Thomas V.; Tormoen, Garth W.

2014-01-01

The study of blood ex vivo can occur in closed or open systems, with or without flow. Microfluidic devices facilitate measurements of platelet function, coagulation biology, cellular biorheology, adhesion dynamics, pharmacology, and clinical diagnostics. An experimental session can accommodate 100s to 1000s of unique clotting events. Using microfluidics, thrombotic events can be studied on defined surfaces of biopolymers, matrix proteins, and tissue factor under constant flow rate or constant pressure drop conditions. Distinct shear rates can be created on a device with a single perfusion pump. Microfluidic devices facilitated the determination of intraluminal thrombus permeability and the discovery that platelet contractility can be activated by a sudden decrease in flow. Microfluidics are ideal for multicolor imaging of platelets, fibrin, and phosphatidylserine and provide a human blood analog to the mouse injury models. Overall, microfluidic advances offer many opportunities for research, drug testing under relevant hemodynamic conditions, and clinical diagnostics. PMID:23642241

Smartphone chloridometer for point-of-care applications

NASA Astrophysics Data System (ADS)

Zhang, Chenji; Kim, Jimin P.; Creer, Michael; Yang, Jian; Liu, Zhiwen

2017-08-01

Chloride level in sweat is a major diagnostic criterion for cystic fibrosis (CF) and many other health conditions. In an effort to develop a low cost, point-of-care sweat diagnostics system for chloride concentration measurement, we demonstrated a smartphone-based chloridometer to measure sweat chloride by using our recently developed fluorescence chloride sensor. We characterized the performance of our device to validate its clinical potential. The study indicates that our smartphone-based chloridometer may potentially advance the point-of-care diagnostic system by reducing cost and improving diagnostic accuracy.

Paper-based analytical devices for clinical diagnosis: recent advances in the fabrication techniques and sensing mechanisms

PubMed Central

Sher, Mazhar; Zhuang, Rachel; Demirci, Utkan; Asghar, Waseem

2017-01-01

Introduction There is a significant interest in developing inexpensive portable biosensing platforms for various applications including disease diagnostics, environmental monitoring, food safety, and water testing at the point-of-care (POC) settings. Current diagnostic assays available in the developed world require sophisticated laboratory infrastructure and expensive reagents. Hence, they are not suitable for resource-constrained settings with limited financial resources, basic health infrastructure, and few trained technicians. Cellulose and flexible transparency paper-based analytical devices have demonstrated enormous potential for developing robust, inexpensive and portable devices for disease diagnostics. These devices offer promising solutions to disease management in resource-constrained settings where the vast majority of the population cannot afford expensive and highly sophisticated treatment options. Areas covered In this review, the authors describe currently developed cellulose and flexible transparency paper-based microfluidic devices, device fabrication techniques, and sensing technologies that are integrated with these devices. The authors also discuss the limitations and challenges associated with these devices and their potential in clinical settings. Expert commentary In recent years, cellulose and flexible transparency paper-based microfluidic devices have demonstrated the potential to become future healthcare options despite a few limitations such as low sensitivity and reproducibility. PMID:28103450

Paper-based analytical devices for clinical diagnosis: recent advances in the fabrication techniques and sensing mechanisms.

PubMed

Sher, Mazhar; Zhuang, Rachel; Demirci, Utkan; Asghar, Waseem

2017-04-01

There is a significant interest in developing inexpensive portable biosensing platforms for various applications including disease diagnostics, environmental monitoring, food safety, and water testing at the point-of-care (POC) settings. Current diagnostic assays available in the developed world require sophisticated laboratory infrastructure and expensive reagents. Hence, they are not suitable for resource-constrained settings with limited financial resources, basic health infrastructure, and few trained technicians. Cellulose and flexible transparency paper-based analytical devices have demonstrated enormous potential for developing robust, inexpensive and portable devices for disease diagnostics. These devices offer promising solutions to disease management in resource-constrained settings where the vast majority of the population cannot afford expensive and highly sophisticated treatment options. Areas covered: In this review, the authors describe currently developed cellulose and flexible transparency paper-based microfluidic devices, device fabrication techniques, and sensing technologies that are integrated with these devices. The authors also discuss the limitations and challenges associated with these devices and their potential in clinical settings. Expert commentary: In recent years, cellulose and flexible transparency paper-based microfluidic devices have demonstrated the potential to become future healthcare options despite a few limitations such as low sensitivity and reproducibility.

Medical diagnostics with mobile devices: Comparison of intrinsic and extrinsic sensing.

PubMed

Kwon, L; Long, K D; Wan, Y; Yu, H; Cunningham, B T

2016-01-01

We review the recent development of mobile detection instruments used for medical diagnostics, and consider the relative advantages of approaches that utilize the internal sensing capabilities of commercially available mobile communication devices (such as smartphones and tablet computers) compared to those that utilize a custom external sensor module. In this review, we focus specifically upon mobile medical diagnostic platforms that are being developed to serve the need in global health, personalized medicine, and point-of-care diagnostics. Copyright © 2016 Elsevier Inc. All rights reserved.

Evaluation of the Parasight Platform for Malaria Diagnosis

PubMed Central

Eshel, Yochay; Houri-Yafin, Arnon; Benkuzari, Hagai; Lezmy, Natalie; Soni, Mamta; Charles, Malini; Swaminathan, Jayanthi; Solomon, Hilda; Sampathkumar, Pavithra; Premji, Zul; Mbithi, Caroline; Nneka, Zaitun; Onsongo, Simon; Maina, Daniel; Levy-Schreier, Sarah; Cohen, Caitlin Lee; Gluck, Dan; Pollak, Joseph Joel

2016-01-01

ABSTRACT The World Health Organization estimates that nearly 500 million malaria tests are performed annually. While microscopy and rapid diagnostic tests (RDTs) are the main diagnostic approaches, no single method is inexpensive, rapid, and highly accurate. Two recent studies from our group have demonstrated a prototype computer vision platform that meets those needs. Here we present the results from two clinical studies on the commercially available version of this technology, the Sight Diagnostics Parasight platform, which provides malaria diagnosis, species identification, and parasite quantification. We conducted a multisite trial in Chennai, India (Apollo Hospital [n = 205]), and Nairobi, Kenya (Aga Khan University Hospital [n = 263]), in which we compared the device to microscopy, RDTs, and PCR. For identification of malaria, the device performed similarly well in both contexts (sensitivity of 99% and specificity of 100% at the Indian site and sensitivity of 99.3% and specificity of 98.9% at the Kenyan site, compared to PCR). For species identification, the device correctly identified 100% of samples with Plasmodium vivax and 100% of samples with Plasmodium falciparum in India and 100% of samples with P. vivax and 96.1% of samples with P. falciparum in Kenya, compared to PCR. Lastly, comparisons of the device parasite counts with those of trained microscopists produced average Pearson correlation coefficients of 0.84 at the Indian site and 0.85 at the Kenyan site. PMID:27974542

Horizon 2020 SME-Instrument topic: clinical research for the validation of biomarkers and/or diagnostic medical devices.

PubMed

Sanne, Jean-Luc

2018-06-21

The European Commission released €130 million over 2014, 2015 and 2017 under the EU Framework Program for Research and Innovation, Horizon 2020, to support innovative small and medium-sized enterprises in the diagnostic area. The call topic focused on 'Clinical research for the validation of biomarkers and/or diagnostic medical devices'. It attracted 1194 applicants from all over Europe. The quality of the proposals was high and a large proportion of them were eligible for funding. In the majority, proposals were about in vitro diagnostics and tackled both clinical validation of new biomarkers and device optimization. The proposals dealt with various advanced technologies. One third of the proposers gave priority to the new and promising field of personalized medicine.

Design of practical alignment device in KSTAR Thomson diagnostic

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lee, J. H., E-mail: jhlee@nfri.re.kr; University of Science and Technology; Lee, S. H.

2016-11-15

The precise alignment of the laser path and collection optics in Thomson scattering measurements is essential for accurately determining electron temperature and density in tokamak experiments. For the last five years, during the development stage, the KSTAR tokamak’s Thomson diagnostic system has had alignment fibers installed in its optical collection modules, but these lacked a proper alignment detection system. In order to address these difficulties, an alignment verifying detection device between lasers and an object field of collection optics is developed. The alignment detection device utilizes two types of filters: a narrow laser band wavelength for laser, and a broadmore » wavelength filter for Thomson scattering signal. Four such alignment detection devices have been successfully developed for the KSTAR Thomson scattering system in this year, and these will be tested in KSTAR experiments in 2016. In this paper, we present the newly developed alignment detection device for KSTAR’s Thomson scattering diagnostics.« less

Design of practical alignment device in KSTAR Thomson diagnostic.

PubMed

Lee, J H; Lee, S H; Yamada, I

2016-11-01

The precise alignment of the laser path and collection optics in Thomson scattering measurements is essential for accurately determining electron temperature and density in tokamak experiments. For the last five years, during the development stage, the KSTAR tokamak's Thomson diagnostic system has had alignment fibers installed in its optical collection modules, but these lacked a proper alignment detection system. In order to address these difficulties, an alignment verifying detection device between lasers and an object field of collection optics is developed. The alignment detection device utilizes two types of filters: a narrow laser band wavelength for laser, and a broad wavelength filter for Thomson scattering signal. Four such alignment detection devices have been successfully developed for the KSTAR Thomson scattering system in this year, and these will be tested in KSTAR experiments in 2016. In this paper, we present the newly developed alignment detection device for KSTAR's Thomson scattering diagnostics.

Control of OSA during automatic positive airway pressure titration in a clinical case series: predictors and accuracy of device download data.

PubMed

Huang, Hsin-Chia Carol; Hillman, David R; McArdle, Nigel

2012-09-01

To investigate the factors associated with physiologic control of obstructive sleep apnea (OSA) during automatic positive airway pressure (APAP) titration in a clinical series. To also assess the usefulness of apnea-hypopnea index (AHI) data downloaded from the APAP device (Dev AHI). Retrospective review of a consecutive series of patients with OSA who underwent APAP titration (Autoset Spirit, ResMed, Bella Vista, New South Wales, Australia ) with simultaneous polysomnographic (PSG) monitoring in the sleep laboratory. Tertiary sleep clinic. There were 190 consecutive patients with OSA referred for APAP titration. There were 58% of patients who achieved optimal or good control of OSA (titration PSG AHI < 10, or at least 50% reduction in AHI if diagnostic AHI < 15/hr) during APAP titration. The independent predictors of titration PSG AHI were a history of cardiac disease and elevated central apnea and arousal indices during the diagnostic study. Although the median and interquartile range (IQR) AHI from the device (7.0, 3.9-11.6 events/hr) was only slightly less than the PSG AHI (7.8, 3.9-14.4 events/hr, P = 0.04) during titration, case-by-case agreement between the two measures was poor (chi-square < 0.001). In a clinical sample control of OSA during APAP titration is often poor, and close clinical follow-up is particularly needed in patients with a history of cardiac disease or with high arousal or central apnea indices on the diagnostic study. Device AHI does not reliably assess control during APAP titration, and PSG assessment may be required if clinical response to treatment is poor. The findings relate to the ResMed AutoSet device and may not apply to other devices.

Point-of-care coagulation monitoring: first clinical experience using a paper-based lateral flow diagnostic device.

PubMed

Hegener, Michael A; Li, Hua; Han, Daewoo; Steckl, Andrew J; Pauletti, Giovanni M

2017-09-01

Vitamin K antagonists such as warfarin are the most widely used class of oral anticoagulants. Due to a narrow therapeutic window, patients on warfarin require regular monitoring. Self-testing using point-of-care (POC) diagnostic devices is available, but cost makes this monitoring method beyond reach for many. The main objective of this research was to assess the clinical utility of a low-cost, paper-based lateral flow POC diagnostic device developed for anticoagulation monitoring without the need for a separate electronic reader. Custom-fabricated lateral flow assay (LFA) test strips comprised of a glass fiber sample pad, a nitrocellulose analytical membrane, a cellulose wicking pad, and a plastic backing card were assembled in a plastic cassette. Healthy volunteers and patients on warfarin therapy were recruited for this prospective study. For each participant, a whole blood sample was collected via fingerstick to determine: (1) international normalized ratio (INR) using the CoaguChek® XS coagulometer, (2) hematocrit by centrifugation, and (3) red blood cell (RBC) travel distance on the experimental LFA device after 240 s using digital image analysis. RBC travel distance measured on the LFA device using blood samples obtained from warfarin patients positively correlated with increasing INR value and the LFA device had the capability to statistically distinguish between healthy volunteer INR values and those for patients groups with INR ≥ 2.6. From these data, it is predicted that this low-cost, paper-based LFA device can have clinical utility for identifying anticoagulated patients taking vitamin K antagonists who are outside of the desired therapeutic efficacy window.

Functional reasoning in diagnostic problem solving

NASA Technical Reports Server (NTRS)

Sticklen, Jon; Bond, W. E.; Stclair, D. C.

1988-01-01

This work is one facet of an integrated approach to diagnostic problem solving for aircraft and space systems currently under development. The authors are applying a method of modeling and reasoning about deep knowledge based on a functional viewpoint. The approach recognizes a level of device understanding which is intermediate between a compiled level of typical Expert Systems, and a deep level at which large-scale device behavior is derived from known properties of device structure and component behavior. At this intermediate functional level, a device is modeled in three steps. First, a component decomposition of the device is defined. Second, the functionality of each device/subdevice is abstractly identified. Third, the state sequences which implement each function are specified. Given a functional representation and a set of initial conditions, the functional reasoner acts as a consequence finder. The output of the consequence finder can be utilized in diagnostic problem solving. The paper also discussed ways in which this functional approach may find application in the aerospace field.

76 FR 77834 - Scientific Information Request on Intravascular Diagnostic and Imaging Medical Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-14

... solicited to inform our Comparative Effectiveness Review of Intravascular Diagnostic Procedures and Imaging... scientific information on this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review...

21 CFR 872.1745 - Laser fluorescence caries detection device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1745 Laser fluorescence caries... fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as...

21 CFR 872.1745 - Laser fluorescence caries detection device.

Code of Federal Regulations, 2014 CFR

2014-04-01

... SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1745 Laser fluorescence caries... fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as...

Insights into Atherosclerosis Using Nanotechnology

PubMed Central

Linton, MacRae F.; Fazio, Sergio; Haselton, Frederick R.

2010-01-01

A developing forefront in vascular disease research is the application of nanotechnology, the engineering of devices at the molecular scale, for diagnostic and therapeutic applications in atherosclerosis. Promising research in this field over the past decade has resulted in the preclinical validation of nanoscale devices that target cellular and molecular components of the atherosclerotic plaque, including one of its prominent cell types, the macrophage. Nanoscale contrast agents targeting constituents of plaque biology have been adapted for application in multiple imaging modalities, leading toward more detailed diagnostic readouts, whereas nanoscale drug delivery devices can be tailored for site-specific therapeutic activity. This review highlights recent progress in utilizing nanotechnology for the clinical management of atherosclerosis, drawing upon recent preclinical studies relevant to diagnosis and treatment of the plaque and promising future applications. PMID:20425261

How to: evaluate a diagnostic test.

PubMed

Leeflang, Mariska M G; Allerberger, Franz

2018-06-12

The development of an in vitro diagnostic test from a good idea to a clinically relevant tool takes several steps, with more stringent requirements at every step. This article aims to summarize the necessary questions to be asked about a test and to illustrate study designs answering these questions. We also aim to relate the Regulation (EU) 2017/746 to the needs of evidence-based diagnostic testing, where applicable. We used literature on evidence-based diagnostics, a text book on clinical trials in the development and marketing of medical devices and the English version of Regulation 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices. The combination of different test uses and different stages of development determine the required test characteristics and suitability of study designs. In an earlier stage of test development it may be crucial to know whether a test can differentiate diseased persons from healthy controls, while this tells us little about how a test will perform in practice. Later stages focus on the diagnostic accuracy of a test in a clinically relevant situation. However, a test that perfectly distinguishes between patients with and without a certain condition may still have little effect on patient outcomes. Therefore, randomized controlled trials of testing may be needed, as well as post-marketing monitoring. Both researchers and users of tests need to be aware of the limitations of diagnostic test accuracy and realize that accuracy is only indirectly linked to people's health status. Copyright © 2018. Published by Elsevier Ltd.

Malaria Rapid Diagnostic Devices: Performance Characteristics of the ParaSight F Device Determined in a Multisite Field Study

PubMed Central

Forney, J. Russ; Magill, Alan J.; Wongsrichanalai, Chansuda; Sirichaisinthop, Jeeraphat; Bautista, Christian T.; Heppner, D. Gray; Miller, R. Scott; Ockenhouse, Christian F.; Gubanov, Alex; Shafer, Robyn; DeWitt, Caroline Cady; Quino-Ascurra, Higinio A.; Kester, Kent E.; Kain, Kevin C.; Walsh, Douglas S.; Ballou, W. Ripley; Gasser, Robert A.

2001-01-01

Microscopic detection of parasites has been the reference standard for malaria diagnosis for decades. However, difficulty in maintaining required technical skills and infrastructure has spurred the development of several nonmicroscopic malaria rapid diagnostic devices based on the detection of malaria parasite antigen in whole blood. The ParaSight F test is one such device. It detects the presence of Plasmodium falciparum-specific histidine-rich protein 2 by using an antigen-capture immunochromatographic strip format. The present study was conducted at outpatient malaria clinics in Iquitos, Peru, and Maesod, Thailand. Duplicate, blinded, expert microscopy was employed as the reference standard for evaluating device performance. Of 2,988 eligible patients, microscopy showed that 547 (18%) had P. falciparum, 658 (22%) had P. vivax, 2 (0.07%) had P. malariae, and 1,750 (59%) were negative for Plasmodium. Mixed infections (P. falciparum and P. vivax) were identified in 31 patients (1%). The overall sensitivity of ParaSight F for P. falciparum was 95%. When stratified by magnitude of parasitemia (no. of asexual parasites per microliter of whole blood), sensitivities were 83% (>0 to 500 parasites/μl), 87% (501 to 1,000/μl), 98% (1,001 to 5,000/μl), and 98% (>5,000/μl). Device specificity was 86%. PMID:11474008

Microfluidic paper-based analytical devices for potential use in quantitative and direct detection of disease biomarkers in clinical analysis.

PubMed

Lim, Wei Yin; Goh, Boon Tong; Khor, Sook Mei

2017-08-15

Clinicians, working in the health-care diagnostic systems of developing countries, currently face the challenges of rising costs, increased number of patient visits, and limited resources. A significant trend is using low-cost substrates to develop microfluidic devices for diagnostic purposes. Various fabrication techniques, materials, and detection methods have been explored to develop these devices. Microfluidic paper-based analytical devices (μPADs) have gained attention for sensing multiplex analytes, confirming diagnostic test results, rapid sample analysis, and reducing the volume of samples and analytical reagents. μPADs, which can provide accurate and reliable direct measurement without sample pretreatment, can reduce patient medical burden and yield rapid test results, aiding physicians in choosing appropriate treatment. The objectives of this review are to provide an overview of the strategies used for developing paper-based sensors with enhanced analytical performances and to discuss the current challenges, limitations, advantages, disadvantages, and future prospects of paper-based microfluidic platforms in clinical diagnostics. μPADs, with validated and justified analytical performances, can potentially improve the quality of life by providing inexpensive, rapid, portable, biodegradable, and reliable diagnostics. Copyright © 2017 Elsevier B.V. All rights reserved.

21 CFR 809.3 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-04-01

... examination of specimens taken from the human body. These products are devices as defined in section 201(h) of... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE General Provisions § 809.3 Definitions. (a) In vitro diagnostic...

21 CFR 809.3 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-04-01

... examination of specimens taken from the human body. These products are devices as defined in section 201(h) of... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE General Provisions § 809.3 Definitions. (a) In vitro diagnostic...

21 CFR 809.3 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-04-01

... examination of specimens taken from the human body. These products are devices as defined in section 201(h) of... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE General Provisions § 809.3 Definitions. (a) In vitro diagnostic...

21 CFR 866.5180 - Fecal calprotectin immunological test system.

Code of Federal Regulations, 2011 CFR

2011-04-01

... immunological test system is an in vitro diagnostic device that consists of reagents used to quantitatively measure, by immunochemical techniques, fecal calprotectin in human stool specimens. The device is intended forin vitro diagnostic use as an aid in the diagnosis of inflammatory bowel diseases (IBD), specifically...

21 CFR 809.3 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-04-01

... examination of specimens taken from the human body. These products are devices as defined in section 201(h) of... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE General Provisions § 809.3 Definitions. (a) In vitro diagnostic...

21 CFR 809.3 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... examination of specimens taken from the human body. These products are devices as defined in section 201(h) of... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE General Provisions § 809.3 Definitions. (a) In vitro diagnostic...

Emergency CT brain: preliminary interpretation with a tablet device: image quality and diagnostic performance of the Apple iPad.

PubMed

Mc Laughlin, Patrick; Neill, Siobhan O; Fanning, Noel; Mc Garrigle, Anne Marie; Connor, Owen J O; Wyse, Gerry; Maher, Michael M

2012-04-01

Tablet devices have recently been used in radiological image interpretation because they have a display resolution comparable to desktop LCD monitors. We identified a need to examine tablet display performance prior to their use in preliminary interpretation of radiological images. We compared the spatial and contrast resolution of a commercially available tablet display with a diagnostic grade 2 megapixel monochrome LCD using a contrast detail phantom. We also recorded reporting discrepancies, using the ACR RADPEER system, between preliminary interpretation of 100 emergency CT brain examinations on the tablet display and formal review on a diagnostic LCD. The iPad display performed inferiorly to the diagnostic monochrome display without the ability to zoom. When the software zoom function was enabled on the tablet device, comparable contrast detail phantom scores of 163 vs 165 points were achieved. No reporting discrepancies were encountered during the interpretation of 43 normal examinations and five cases of acute intracranial hemorrhage. There were seven RADPEER2 (understandable) misses when using the iPad display and 12 with the diagnostic LCD. Use of software zoom in the tablet device improved its contrast detail phantom score. The tablet allowed satisfactory identification of acute CT brain findings, but additional research will be required to examine the cause of "understandable" reporting discrepancies that occur when using tablet devices.

Portable Bio/Chemosensoristic Devices: Innovative Systems for Environmental Health and Food Safety Diagnostics

PubMed Central

Dragone, Roberto; Grasso, Gerardo; Muccini, Michele; Toffanin, Stefano

2017-01-01

This mini-review covers the newly developed biosensoristic and chemosensoristic devices described in recent literature for detection of contaminants in both environmental and food real matrices. Current needs in environmental and food surveillance of contaminants require new simplified, sensitive systems, which are portable and allow for rapid and on-site monitoring and diagnostics. Here, we focus on optical and electrochemical bio/chemosensoristic devices as promising tools with interesting analytical features that can be potentially exploited for innovative on-site and real-time applications for diagnostics and monitoring of environmental and food matrices (e.g., agricultural waters and milk). In near future, suitably developed and implemented bio/chemosensoristic devices will be a new and modern technological solution for the identification of new quality and safety marker indexes as well as for a more proper and complete characterization of abovementioned environmental and food matrices. Integrated bio/chemosensoristic devices can also allow an “holistic approach” that may prove to be more suitable for diagnostics of environmental and food real matrices, where the copresence of more bioactive substances is frequent. Therefore, this approach can be focused on the determination of net effect (mixture effect) of bioactive substances present in real matrices. PMID:28529937

Portable Bio/Chemosensoristic Devices: Innovative Systems for Environmental Health and Food Safety Diagnostics.

PubMed

Dragone, Roberto; Grasso, Gerardo; Muccini, Michele; Toffanin, Stefano

2017-01-01

This mini-review covers the newly developed biosensoristic and chemosensoristic devices described in recent literature for detection of contaminants in both environmental and food real matrices. Current needs in environmental and food surveillance of contaminants require new simplified, sensitive systems, which are portable and allow for rapid and on-site monitoring and diagnostics. Here, we focus on optical and electrochemical bio/chemosensoristic devices as promising tools with interesting analytical features that can be potentially exploited for innovative on-site and real-time applications for diagnostics and monitoring of environmental and food matrices (e.g., agricultural waters and milk). In near future, suitably developed and implemented bio/chemosensoristic devices will be a new and modern technological solution for the identification of new quality and safety marker indexes as well as for a more proper and complete characterization of abovementioned environmental and food matrices. Integrated bio/chemosensoristic devices can also allow an "holistic approach" that may prove to be more suitable for diagnostics of environmental and food real matrices, where the copresence of more bioactive substances is frequent. Therefore, this approach can be focused on the determination of net effect (mixture effect) of bioactive substances present in real matrices.

21 CFR 872.2050 - Dental sonography device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Dental sonography device. 872.2050 Section 872...) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.2050 Dental sonography device. (a) Dental sonography device for monitoring—(1) Identification. A dental sonography device for monitoring is an...

21 CFR 872.2050 - Dental sonography device.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Dental sonography device. 872.2050 Section 872...) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.2050 Dental sonography device. (a) Dental sonography device for monitoring—(1) Identification. A dental sonography device for monitoring is an...

21 CFR 872.2050 - Dental sonography device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Dental sonography device. 872.2050 Section 872...) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.2050 Dental sonography device. (a) Dental sonography device for monitoring—(1) Identification. A dental sonography device for monitoring is an...

21 CFR 872.2050 - Dental sonography device.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Dental sonography device. 872.2050 Section 872...) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.2050 Dental sonography device. (a) Dental sonography device for monitoring—(1) Identification. A dental sonography device for monitoring is an...

21 CFR 872.2050 - Dental sonography device.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Dental sonography device. 872.2050 Section 872...) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.2050 Dental sonography device. (a) Dental sonography device for monitoring—(1) Identification. A dental sonography device for monitoring is an...

Electronic-nose devices - Potential for noninvasive early disease-detection applications

Treesearch

Alphus Dan Wilson

2017-01-01

Significant progress in the development of portable electronic devices is showing considerable promise to facilitate clinical diagnostic processes. The increasing global trend of shifts in healthcare policies and priorities toward shortening and improving the effectiveness of diagnostic procedures by utilizing non-invasive methods should provide multiple benefits of...

76 FR 41803 - Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-15

... of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza... of Influenza Viruses.'' FDA is issuing this guidance to inform industry and Agency staff of its... diagnostic devices intended for the detection or detection and differentiation of influenza viruses. DATES...

21 CFR 886.1120 - Opthalmic camera.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1120 Opthalmic camera. (a) Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area...

21 CFR 892.2020 - Medical image communications device.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical image communications device. 892.2020... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of medical...

21 CFR 892.2020 - Medical image communications device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical image communications device. 892.2020... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of medical...

21 CFR 892.2020 - Medical image communications device.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image communications device. 892.2020... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of medical...

21 CFR 892.2020 - Medical image communications device.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical image communications device. 892.2020... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of medical...

21 CFR 872.1740 - Caries detection device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Caries detection device. 872.1740 Section 872.1740...) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1740 Caries detection device. (a) Identification. The caries detection device is a device intended to show the existence of decay in a patient's tooth...

21 CFR 892.2010 - Medical image storage device.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and retrieval...

21 CFR 892.2010 - Medical image storage device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and retrieval...

21 CFR 892.2010 - Medical image storage device.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and retrieval...

21 CFR 892.2010 - Medical image storage device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and retrieval...

21 CFR 886.1450 - Corneal radius measuring device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Corneal radius measuring device. 886.1450 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1450 Corneal radius measuring device. (a) Identification. A corneal radius measuring device is an AC-powered device intended to measure...

21 CFR 892.2010 - Medical image storage device.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and retrieval...

21 CFR 868.1800 - Rhinoanemometer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1800 Rhinoanemometer. (a) Identification. A... differential pressure across, a patient's nasal passages. (b) Classification. Class II (performance standards). ...

21 CFR 872.1830 - Cephalometer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DENTAL DEVICES Diagnostic Devices § 872.1830 Cephalometer. (a) Identification. A cephalometer is a device used in dentistry during x-ray procedures. The device is intended to place and to hold a patient's head...

21 CFR 872.1745 - Laser fluorescence caries detection device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Laser fluorescence caries detection device. 872... SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1745 Laser fluorescence caries detection device. (a) Identification. A laser fluorescence caries detection device is a laser, a...

Comparison of a pocket-size ultrasound device with a premium ultrasound machine: diagnostic value and time required in bedside ultrasound examination.

PubMed

Stock, Konrad Friedrich; Klein, Bettina; Steubl, Dominik; Lersch, Christian; Heemann, Uwe; Wagenpfeil, Stefan; Eyer, Florian; Clevert, Dir-Andre

2015-10-01

Time savings and clinical accuracy of a new miniature ultrasound device was investigated utilizing comparison with conventional high-end ultrasound instruments. Our objective was to determine appropriate usage and limitations of this diagnostic tool in internal medicine. We investigated 28 patients from the internal-medicine department. Patients were examined with the Acuson P10 portable device and a Sonoline Antares instrument in a cross-over design. All investigations were carried out at the bedside; the results were entered on a standardized report form. The time for the ultrasound examination (transfer time, setting up and disassembly, switching on and off, and complete investigation time) was recorded separately. Mean time for overall examination per patient with the portable ultrasound device was shorter (25.0 ± 4.5 min) than with the high-end machine (29.4 ± 4.4 min; p < 0.001). When measuring the size of liver, spleen, and kidneys, the values obtained differed significantly between portable device and the high-end instrument. In our study, we identified 113 pathological ultrasound findings with the high-end ultrasound machine, while 82 pathological findings (73%) were concordantly detected with the portable ultrasound device. The main diagnostic strengths of the portable device were in the detection of ascites (sensitivity 80%), diagnosis of fatty liver, and identification of severe parenchymal liver damage. The clinical utility of portable ultrasound machines is limited. There will be clinical roles for distinct clinical questions such as detection of ascites or pleural effusion when used by experienced examiners. However, sensitivity in detecting multiple pathologies is not comparable to high-end ultrasound machines.

Characterization and Separation of Cancer Cells with a Wicking Fiber Device.

PubMed

Tabbaa, Suzanne M; Sharp, Julia L; Burg, Karen J L

2017-12-01

Current cancer diagnostic methods lack the ability to quickly, simply, efficiently, and inexpensively screen cancer cells from a mixed population of cancer and normal cells. Methods based on biomarkers are unreliable due to complexity of cancer cells, plasticity of markers, and lack of common tumorigenic markers. Diagnostics are time intensive, require multiple tests, and provide limited information. In this study, we developed a novel wicking fiber device that separates cancer and normal cell types. To the best of our knowledge, no previous work has used vertical wicking of cells through fibers to identify and isolate cancer cells. The device separated mouse mammary tumor cells from a cellular mixture containing normal mouse mammary cells. Further investigation showed the device separated and isolated human cancer cells from a heterogeneous mixture of normal and cancerous human cells. We report a simple, inexpensive, and rapid technique that has potential to identify and isolate cancer cells from large volumes of liquid samples that can be translated to on-site clinic diagnosis.

76 FR 69040 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-07

...: In Vitro Diagnostic Devices for Yersinia Species Detection; Availability AGENCY: Food and Drug... availability of a draft guidance entitled ``Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Yersinia Species Detection.'' This draft guidance document describes a means by which in vitro...

75 FR 35045 - Authorization of Emergency Use of Certain In Vitro Diagnostic Devices; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0277] Authorization of Emergency Use of Certain In Vitro Diagnostic Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the issuance...

76 FR 41506 - Draft Guidance for Industry and FDA Staff on In Vitro Companion Diagnostic Devices; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-14

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0215] Draft Guidance for Industry and FDA Staff on In Vitro Companion Diagnostic Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

77 FR 16123 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-19

...; Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the... Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the...

Analytical Chemistry in the Regulatory Science of Medical Devices.

PubMed

Wang, Yi; Guan, Allan; Wickramasekara, Samanthi; Phillips, K Scott

2018-06-12

In the United States, regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all Food and Drug Administration-regulated products. Good regulatory science facilitates consumer access to innovative medical devices that are safe and effective throughout the Total Product Life Cycle (TPLC). Because the need to measure things is fundamental to the regulatory science of medical devices, analytical chemistry plays an important role, contributing to medical device technology in two ways: It can be an integral part of an innovative medical device (e.g., diagnostic devices), and it can be used to support medical device development throughout the TPLC. In this review, we focus on analytical chemistry as a tool for the regulatory science of medical devices. We highlight recent progress in companion diagnostics, medical devices on chips for preclinical testing, mass spectrometry for postmarket monitoring, and detection/characterization of bacterial biofilm to prevent infections.

21 CFR 872.2060 - Jaw tracking device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Jaw tracking device. 872.2060 Section 872.2060 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.2060 Jaw tracking device. (a) Jaw tracking device...

21 CFR 872.2060 - Jaw tracking device.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Jaw tracking device. 872.2060 Section 872.2060 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.2060 Jaw tracking device. (a) Jaw tracking device...

21 CFR 872.2060 - Jaw tracking device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Jaw tracking device. 872.2060 Section 872.2060 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.2060 Jaw tracking device. (a) Jaw tracking device...

21 CFR 872.2060 - Jaw tracking device.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Jaw tracking device. 872.2060 Section 872.2060 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.2060 Jaw tracking device. (a) Jaw tracking device...

Portable devices and mobile instruments for infectious diseases point-of-care testing.

PubMed

Bissonnette, Luc; Bergeron, Michel G

2017-05-01

Rapidity, simplicity, and portability are highly desirable characteristics of tests and devices designed for performing diagnostics at the point of care (POC), either near patients managed in healthcare facilities or to offer bioanalytical alternatives in external settings. By reducing the turnaround time of the diagnostic cycle, POC diagnostics can reduce the dissemination, morbidity, and mortality of infectious diseases and provide tools to control the global threat of antimicrobial resistance. Areas covered: A literature search of PubMed and Google Scholar, and extensive mining of specialized publications, Internet resources, and manufacturers' websites have been used to organize and write this overview of the challenges and requirements associated with the development of portable sample-to-answer diagnostics, and showcase relevant examples of handheld devices, portable instruments, and less mobile systems which may or could be operated at POC. Expert commentary: Rapid (<1 h) diagnostics can contribute to control infectious diseases and antimicrobial resistant pathogens. Portable devices or instruments enabling sample-to-answer bioanalysis can provide rapid, robust, and reproducible testing at the POC or close from it. Beyond testing, to realize some promises of personalized/precision medicine, it will be critical to connect instruments to healthcare data management systems, to efficiently link decentralized testing results to the electronic medical record of patients.

High-Content Optical Codes for Protecting Rapid Diagnostic Tests from Counterfeiting.

PubMed

Gökçe, Onur; Mercandetti, Cristina; Delamarche, Emmanuel

2018-06-19

Warnings and reports on counterfeit diagnostic devices are released several times a year by regulators and public health agencies. Unfortunately, mishandling, altering, and counterfeiting point-of-care diagnostics (POCDs) and rapid diagnostic tests (RDTs) is lucrative, relatively simple and can lead to devastating consequences. Here, we demonstrate how to implement optical security codes in silicon- and nitrocellulose-based flow paths for device authentication using a smartphone. The codes are created by inkjet spotting inks directly on nitrocellulose or on micropillars. Codes containing up to 32 elements per mm 2 and 8 colors can encode as many as 10 45 combinations. Codes on silicon micropillars can be erased by setting a continuous flow path across the entire array of code elements or for nitrocellulose by simply wicking a liquid across the code. Static or labile code elements can further be formed on nitrocellulose to create a hidden code using poly(ethylene glycol) (PEG) or glycerol additives to the inks. More advanced codes having a specific deletion sequence can also be created in silicon microfluidic devices using an array of passive routing nodes, which activate in a particular, programmable sequence. Such codes are simple to fabricate, easy to view, and efficient in coding information; they can be ideally used in combination with information on a package to protect diagnostic devices from counterfeiting.

Cancer drug development and the evolving regulatory framework for companion diagnostics in the European union.

PubMed

Pignatti, Francesco; Ehmann, Falk; Hemmings, Robert; Jonsson, Bertil; Nuebling, Micha; Papaluca-Amati, Marisa; Posch, Martin; Rasi, Guido

2014-03-15

The European Union (EU) legal framework for medical device regulation is currently under revision. The European Commission has proposed a new framework to ensure that medical devices serve the needs and ensure the safety of European citizens, aiming for a framework that is fit for purpose, more transparent, and better adapted to scientific and technological progress. The proposed new framework is described as an evolution of the current regime keeping the same legal approach. An important proposed change is that companion diagnostics will no longer be considered as low risk and subject to self-certification by the manufacturer. According to the new proposal, companion diagnostics will be classified as high individual risk or moderate public health risk (category C) and require conformity assessment by a notified body. It has also been proposed that evidence of the clinical utility of the device for the intended purpose should be required for companion diagnostics. In this article, we review the EU legal framework relevant for companion diagnostics, describe the proposed changes, and summarize the available scientific guidance from the European Medicines Agency and its regulatory experience with cancer drug development including companion diagnostics. See all articles in this CCR Focus section, "The Precision Medicine Conundrum: Approaches to Companion Diagnostic Co-development." ©2014 AACR.

21 CFR 872.1820 - Dental x-ray exposure alignment device.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Dental x-ray exposure alignment device. 872.1820... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1820 Dental x-ray exposure alignment device. (a) Identification. A dental x-ray exposure alignment device is a device intended to position x...

21 CFR 872.1840 - Dental x-ray position indicating device.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Dental x-ray position indicating device. 872.1840... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1840 Dental x-ray position indicating device. (a) Identification. A dental x-ray position indicating device is a device, such as a collimator...

21 CFR 872.1840 - Dental x-ray position indicating device.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Dental x-ray position indicating device. 872.1840... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1840 Dental x-ray position indicating device. (a) Identification. A dental x-ray position indicating device is a device, such as a collimator...

21 CFR 872.1820 - Dental x-ray exposure alignment device.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Dental x-ray exposure alignment device. 872.1820... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1820 Dental x-ray exposure alignment device. (a) Identification. A dental x-ray exposure alignment device is a device intended to position x...

21 CFR 872.1820 - Dental x-ray exposure alignment device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Dental x-ray exposure alignment device. 872.1820... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1820 Dental x-ray exposure alignment device. (a) Identification. A dental x-ray exposure alignment device is a device intended to position x...

21 CFR 872.1820 - Dental x-ray exposure alignment device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Dental x-ray exposure alignment device. 872.1820... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1820 Dental x-ray exposure alignment device. (a) Identification. A dental x-ray exposure alignment device is a device intended to position x...

21 CFR 872.1840 - Dental x-ray position indicating device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Dental x-ray position indicating device. 872.1840... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1840 Dental x-ray position indicating device. (a) Identification. A dental x-ray position indicating device is a device, such as a collimator...

21 CFR 872.1840 - Dental x-ray position indicating device.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Dental x-ray position indicating device. 872.1840... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1840 Dental x-ray position indicating device. (a) Identification. A dental x-ray position indicating device is a device, such as a collimator...

21 CFR 872.1820 - Dental x-ray exposure alignment device.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Dental x-ray exposure alignment device. 872.1820... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1820 Dental x-ray exposure alignment device. (a) Identification. A dental x-ray exposure alignment device is a device intended to position x...

21 CFR 872.1840 - Dental x-ray position indicating device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Dental x-ray position indicating device. 872.1840... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1840 Dental x-ray position indicating device. (a) Identification. A dental x-ray position indicating device is a device, such as a collimator...

21 CFR 892.2040 - Medical image hardcopy device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical image hardcopy device. 892.2040 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical...

21 CFR 892.2040 - Medical image hardcopy device.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical image hardcopy device. 892.2040 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical...

21 CFR 892.2040 - Medical image hardcopy device.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image hardcopy device. 892.2040 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical...

21 CFR 892.2040 - Medical image hardcopy device.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical image hardcopy device. 892.2040 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical...

Ultrasonographic diagnosis of early pregnancy in cattle using different ultrasound systems.

PubMed

Racewicz, Przemysław; Sickinger, Marlene; Włodarek, Jan; Jaśkowski, Jędrzej M

2016-06-16

To evaluate the efficiency of different ultrasound devices in achieving an early diagnosis of pregnancy in dairy herds. A total of 1976 Holstein Friesian cows and heifers were artificially inseminated (AI) according to the herd manager's regime. Pregnancy diagnostics were performed between day 26 and 35 after AI using six different types of ultrasound systems (linear vs. sector scanners). Manual rectal palpation between day 45 and 60 after AI was used as the gold standard for pregnancy diagnostics. Sensitivity (SENS), specificity (SPEC), positive (PPV) and negative predictive value (NPV) and diagnostic accuracy (ACC) of the diagnostic measures were determined. Average SENS was 82% (range 67.7-95.2%) with a mean SPEC of 73% (range 50.0-81.0%). ACC was 78.2% with a minimum of 64.6% and a maximum of 89.4%, depending on the ultrasound system. The PPV (ratio of the number of pregnant cows with a positive examination result to the number of cows actually pregnant) was 80.8% (range 59.1-88.1%), whereas the NPV (defined as the ratio of the number of cows correctly diagnosed negative to the number of cows actually open) was 74.4% (72.3-91.9%). Significant differences for these parameters were found depending on the ultrasound system used (p ≤ 0.01; Cramer's V. = 0.14). Regardless of the ultrasound device used, early pregnancy diagnostics between day 26 and 35 show a moderate diagnostic efficiency. Comparing the accuracy of the different devices, there may be a significant influence of type and technical parameters. Even though ultrasound systems with mechanical sector probes are not as convenient to use as systems with linear probes, according to this study, sector scanners are a reasonable alternative.

Control of OSA During Automatic Positive Airway Pressure Titration in a Clinical Case Series: Predictors and Accuracy of Device Download Data

PubMed Central

Huang, Hsin-Chia Carol; Hillman, David R.; McArdle, Nigel

2012-01-01

Study Objectives: To investigate the factors associated with physiologic control of obstructive sleep apnea (OSA) during automatic positive airway pressure (APAP) titration in a clinical series. To also assess the usefulness of apnea-hypopnea index (AHI) data downloaded from the APAP device (Dev AHI). Design: Retrospective review of a consecutive series of patients with OSA who underwent APAP titration (Autoset Spirit, ResMed, Bella Vista, New South Wales, Australia ) with simultaneous polysomnographic (PSG) monitoring in the sleep laboratory. Setting: Tertiary sleep clinic. Participants: There were 190 consecutive patients with OSA referred for APAP titration. Measurements and Results: There were 58% of patients who achieved optimal or good control of OSA (titration PSG AHI < 10, or at least 50% reduction in AHI if diagnostic AHI < 15/hr) during APAP titration. The independent predictors of titration PSG AHI were a history of cardiac disease and elevated central apnea and arousal indices during the diagnostic study. Although the median and interquartile range (IQR) AHI from the device (7.0, 3.9-11.6 events/hr) was only slightly less than the PSG AHI (7.8, 3.9-14.4 events/hr, P = 0.04) during titration, case-by-case agreement between the two measures was poor (chi-square < 0.001). Conclusion: In a clinical sample control of OSA during APAP titration is often poor, and close clinical follow-up is particularly needed in patients with a history of cardiac disease or with high arousal or central apnea indices on the diagnostic study. Device AHI does not reliably assess control during APAP titration, and PSG assessment may be required if clinical response to treatment is poor. The findings relate to the ResMed AutoSet device and may not apply to other devices. Citation: Huang HCC; Hillman DR; McArdle N. Control of OSA during automatic positive airway pressure titration in a clinical case series: predictors and accuracy of device download data. SLEEP 2012;35(9):1277–1283. PMID:22942506

21 CFR 872.1870 - Sulfide detection device.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Sulfide detection device. 872.1870 Section 872.1870 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1870 Sulfide detection device. (a) Identification...

21 CFR 872.1740 - Caries detection device.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Caries detection device. 872.1740 Section 872.1740 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1740 Caries detection device. (a) Identification...

21 CFR 872.1740 - Caries detection device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Caries detection device. 872.1740 Section 872.1740 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1740 Caries detection device. (a) Identification...

Efficacy of a novel procedure sheath and closure device during diagnostic catheterization: the multicenter randomized clinical trial of the FISH device.

PubMed

Bavry, Anthony A; Raymond, Russell E; Bhatt, Deepak L; Chambers, Charles E; DeNardo, Andrew J; Hermiller, James B; Myers, Paul R; Pitts, Douglas E; Scott, John A; Savader, Scott J; Steinhubl, Steven

2008-04-01

The aim of vascular closure devices is to safely secure the arterial access site at the conclusion of catheterization procedures, thereby increasing patient comfort and decreasing time to hemostasis and ambulation. The FISH (femoral introducer sheath and hemostasis) device is novel in that the access sheath and closure component are incorporated onto the same system. The FISH pivotal investigation was conducted at 8 catheterization laboratories throughout the United States. Eligible diagnostic patients were randomized (2 to 1) to the FISH device versus manual compression and assessed for time to hemostasis and time to ambulation. Half of the participants underwent ultrasonographic evaluation at 30-day follow up. Enrollment for an interventional cohort is ongoing and will be reported at a later date; however, the interventional patients enrolled to date were combined with the diagnostic patients to comprise the safety data of the trial. Overall, 191 patients were randomized to the FISH device and 106 patients to manual compression. Most patients received a 6 Fr sheath (approximately 70%), while the remaining patients received a 5 or 8 Fr sheath. Twenty-seven patients who received the FISH device were converted to manual compression due to anticipated suboptimal hemostasis. Among the diagnostic patients, the mean time to hemostasis was 8.9 minutes for the FISH device, compared to 17.2 minutes for manual compression (p < 0.0001). Similarly, the mean time to ambulation was 2.4 hours for the FISH device, compared to 4.3 hours for manual compression (p < 0.0001). Among the total cohort, there was 1 death and 1 episode of major access-site-related bleeding that required transfusion occurred in the FISH group (1.1%), compared to no serious adverse safety events in the manual compression group (p = 1.0). For the FISH group, there were 5 minor adverse safety events; 3 access-site hematomas and 2 pseudoaneurysms treated with thrombin injection, and in the manual compression group, there was 2 access-site hematomas and 1 pseudoaneurysm treated with thrombin injection (p = 1.0). Among diagnostic patients with good sheath placement and favorable femoral anatomy, the FISH device is superior in achieving time to hemostasis and ambulation compared to manual compression. At 30 days, there is no apparent difference in serious or minor adverse vascular events with the use of the FISH device.

21 CFR 870.1210 - Continuous flush catheter.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1210 Continuous flush catheter. (a) Identification. A continuous flush catheter is an attachment to a catheter-transducer system...

21 CFR 870.1210 - Continuous flush catheter.

Code of Federal Regulations, 2012 CFR

2012-04-01

...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1210 Continuous flush catheter. (a) Identification. A continuous flush catheter is an attachment to a catheter-transducer system...

21 CFR 870.1210 - Continuous flush catheter.

Code of Federal Regulations, 2013 CFR

2013-04-01

...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1210 Continuous flush catheter. (a) Identification. A continuous flush catheter is an attachment to a catheter-transducer system...

21 CFR 882.1570 - Powered direct-contact temperature measurement device.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered direct-contact temperature measurement... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1570 Powered direct-contact temperature measurement device. (a) Identification. A powered direct...

21 CFR 882.1570 - Powered direct-contact temperature measurement device.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Powered direct-contact temperature measurement... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1570 Powered direct-contact temperature measurement device. (a) Identification. A powered direct...

21 CFR 882.1570 - Powered direct-contact temperature measurement device.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Powered direct-contact temperature measurement... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1570 Powered direct-contact temperature measurement device. (a) Identification. A powered direct...

21 CFR 886.1700 - Pupillometer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... eye. (b) Classification. Class I (general controls). The AC-powered device and the manual device are... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1700 Pupillometer. (a) Identification. A pupillometer is an AC...

Label-Free Virus Capture and Release by a Microfluidic Device Integrated with Porous Silicon Nanowire Forest.

PubMed

Xia, Yiqiu; Tang, Yi; Yu, Xu; Wan, Yuan; Chen, Yizhu; Lu, Huaguang; Zheng, Si-Yang

2017-02-01

Viral diseases are perpetual threats to human and animal health. Detection and characterization of viral pathogens require accurate, sensitive, and rapid diagnostic assays. For field and clinical samples, the sample preparation procedures limit the ultimate performance and utility of the overall virus diagnostic protocols. This study presents the development of a microfluidic device embedded with porous silicon nanowire (pSiNW) forest for label-free size-based point-of-care virus capture in a continuous curved flow design. The pSiNW forests with specific interwire spacing are synthesized in situ on both bottom and sidewalls of the microchannels in a batch process. With the enhancement effect of Dean flow, this study demonstrates that about 50% H5N2 avian influenza viruses are physically trapped without device clogging. A unique feature of the device is that captured viruses can be released by inducing self-degradation of the pSiNWs in physiological aqueous environment. About 60% of captured viruses can be released within 24 h for virus culture, subsequent molecular diagnosis, and other virus characterization and analyses. This device performs viable, unbiased, and label-free virus isolation and release. It has great potentials for virus discovery, virus isolation and culture, functional studies of virus pathogenicity, transmission, drug screening, and vaccine development. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Low Light Diagnostics in Thin-Film Photovoltaics

NASA Astrophysics Data System (ADS)

Shvydka, Diana; Karpov, Victor; Compaan, Alvin

2003-03-01

We study statistics of the major photovoltaic (PV) parameters such as open circuit voltage, short circuit current and fill factor vs. light intensity on a set of nominally identical CdTe/CdS solar cells. We found the most probable parameter values to change with the light intensity as predicted by the standard diode model, while their relative fluctuations increase dramatically under low light. The crossover light intensity is found below which the relative fluctuations of the PV parameters diverge inversely proportional to the square root of the light intensity. We propose a model where the observed fluctuations are due to lateral nonuniformities in the device structure. In particular, the crossover is attributed to the lateral nonuniformity screening length exceeding the device size. >From the practical standpoint, our study introduces a simple uniformity diagnostic technique.

21 CFR 864.9225 - Cell-freezing apparatus and reagents for in vitro diagnostic use.

Code of Federal Regulations, 2012 CFR

2012-04-01

... use are devices used to freeze human red blood cells for in vitro diagnostic use. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E... Establishments That Manufacture Blood and Blood Products § 864.9225 Cell-freezing apparatus and reagents for in...

21 CFR 864.9225 - Cell-freezing apparatus and reagents for in vitro diagnostic use.

Code of Federal Regulations, 2014 CFR

2014-04-01

... use are devices used to freeze human red blood cells for in vitro diagnostic use. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E... Establishments That Manufacture Blood and Blood Products § 864.9225 Cell-freezing apparatus and reagents for in...

21 CFR 864.9225 - Cell-freezing apparatus and reagents for in vitro diagnostic use.

Code of Federal Regulations, 2013 CFR

2013-04-01

... use are devices used to freeze human red blood cells for in vitro diagnostic use. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E... Establishments That Manufacture Blood and Blood Products § 864.9225 Cell-freezing apparatus and reagents for in...

21 CFR 892.1670 - Spot-film device.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Spot-film device. 892.1670 Section 892.1670 Food... DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1670 Spot-film device. (a) Identification. A spot-film... medical purposes to position a radiographic film cassette to obtain radiographs during fluoroscopy. (b...

21 CFR 892.1670 - Spot-film device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Spot-film device. 892.1670 Section 892.1670 Food... DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1670 Spot-film device. (a) Identification. A spot-film... medical purposes to position a radiographic film cassette to obtain radiographs during fluoroscopy. (b...

21 CFR 892.1670 - Spot-film device.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Spot-film device. 892.1670 Section 892.1670 Food... DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1670 Spot-film device. (a) Identification. A spot-film... medical purposes to position a radiographic film cassette to obtain radiographs during fluoroscopy. (b...

21 CFR 892.1670 - Spot-film device.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Spot-film device. 892.1670 Section 892.1670 Food... DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1670 Spot-film device. (a) Identification. A spot-film... medical purposes to position a radiographic film cassette to obtain radiographs during fluoroscopy. (b...

21 CFR 892.1670 - Spot-film device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Spot-film device. 892.1670 Section 892.1670 Food... DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1670 Spot-film device. (a) Identification. A spot-film... medical purposes to position a radiographic film cassette to obtain radiographs during fluoroscopy. (b...

Advancing Diagnostics to Address Antibacterial Resistance: The Diagnostics and Devices Committee of the Antibacterial Resistance Leadership Group

PubMed Central

Tsalik, Ephraim L.; Petzold, Elizabeth; Kreiswirth, Barry N.; Bonomo, Robert A.; Banerjee, Ritu; Lautenbach, Ebbing; Evans, Scott R.; Hanson, Kimberly E.; Klausner, Jeffrey D.

2017-01-01

Abstract Diagnostics are a cornerstone of the practice of infectious diseases. However, various limitations frequently lead to unmet clinical needs. In most other domains, diagnostics focus on narrowly defined questions, provide readily interpretable answers, and use true gold standards for development. In contrast, infectious diseases diagnostics must contend with scores of potential pathogens, dozens of clinical syndromes, emerging pathogens, rapid evolution of existing pathogens and their associated resistance mechanisms, and the absence of gold standards in many situations. In spite of these challenges, the importance and value of diagnostics cannot be underestimated. Therefore, the Antibacterial Resistance Leadership Group has identified diagnostics as 1 of 4 major areas of emphasis. Herein, we provide an overview of that development, highlighting several examples where innovation in study design, content, and execution is advancing the field of infectious diseases diagnostics. PMID:28350903

[Projects to accelerate the practical use of innovative medical devices to collaborate with TWIns, Center for Advanced Biomedical Sciences, Waseda University and School of Engineering, The University of Tokyo].

PubMed

Niimi, Shingo; Umezu, Mitsuo; Iseki, Hiroshi; Harada, Hiroshi Kasanuki Noboru; Mitsuishi, Mamoru; Kitamori, Takehiko; Tei, Yuichi; Nakaoka, Ryusuke; Haishima, Yuji

2014-01-01

Division of Medical Devices has been conducting the projects to accelerate the practical use of innovative medical devices to collaborate with TWIns, Center for Advanced Biomedical Sciences, Waseda University and School of Engineering, The University of Tokyo. The TWIns has been studying to aim at establishment of preclinical evaluation methods by "Engineering Based Medicine", and established Regulatory Science Institute for Medical Devices. School of Engineering, The University of Tokyo has been studying to aim at establishment of assessment methodology for innovative minimally invasive therapeutic devices, materials, and nanobio diagnostic devices. This report reviews the exchanges of personnel, the implement systems and the research progress of these projects.

76 FR 72951 - Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-28

... recommendations for studies to establish the performance characteristics of in vitro diagnostic devices (IVDs... issuing this guidance to provide industry and Agency staff with recommendations for studies to establish...

A Novel Intraurethral Device Diagnostic Index to Classify Bladder Outlet Obstruction in Men with Lower Urinary Tract Symptoms

PubMed Central

Reis, Leonardo O.; Barreiro, Guilherme C.; Prudente, Alessandro; Silva, Cleide M.; Bassani, José W. M.; D'Ancona, Carlos A. L.

2009-01-01

Objectives. Using a urethral device at the fossa navicularis, bladder pressure during voiding can be estimated by a minimal invasive technique. This study purposes a new diagnostic index for patients with lower urinary tract symptoms (LUTSs). Methods. Fifty one patients presenting with LUTSs were submitted to a conventional urodynamic and a minimal invasive study. The results obtained through the urethral device and invasive classic urodynamics were compared. The existing bladder outlet obstruction index (BOOI) equation that classifies men with LUTSs was modified to allow minimal invasive measurement of isovolumetric bladder pressure in place of detrusor pressure at maximum urine flow. Accuracy of the new equation for classifying obstruction was then tested in this group of men. Results. The modified equation identified men with obstruction with a positive predictive value of 68% and a negative predictive value of 70%, with an overall accuracy of 70%. Conclusions. The proposed equation can accurately classify over 70% of men without resorting to invasive pressure flow studies. We must now evaluate the usefulness of this classification for the surgical treatment of men with LUTSs. PMID:19125194

Product qualification: a barrier to point-of-care microfluidic-based diagnostics?

PubMed

Tantra, Ratna; van Heeren, Henne

2013-06-21

One of the most exciting applications of microfluidics-based diagnostics is its potential use in next generation point-of-care (POC) devices. Many prototypes are already in existence, but, as of yet, few have achieved commercialisation. In this article, we consider the issue surrounding product qualification as a potential barrier to market success. The study discusses, in the context of POC microfluidics-based diagnostics, what the generic issues are and potential solutions. Our findings underline the need for a community-based effort that is necessary to speed up the product qualification process.

An FDA Perspective on the Regulatory Implications of Complex Signatures to Predict Response to Targeted Therapies

PubMed Central

Beaver, Julia A.; Tzou, Abraham; Blumenthal, Gideon M.; McKee, Amy E.; Kim, Geoffrey; Pazdur, Richard; Philip, Reena

2016-01-01

As technologies evolve, and diagnostics move from detection of single biomarkers toward complex signatures, an increase in the clinical use and regulatory submission of complex signatures is anticipated. However, to date, no complex signatures have been approved as companion diagnostics. In this article, we will describe the potential benefit of complex signatures and their unique regulatory challenges including analytical performance validation, complex signature simulation, and clinical performance evaluation. We also will review the potential regulatory pathways for clearance, approval, or acceptance of complex signatures by the U.S. Food and Drug Administration (FDA). These regulatory pathways include regulations applicable to in vitro diagnostic devices, including companion diagnostic devices, the potential for labeling as a complementary diagnostic, and the biomarker qualification program. PMID:27993967

Point-of-Care Diagnostics for Niche Applications

PubMed Central

Cummins, Brian M.; Ligler, Frances S.; Walker, Glenn M.

2016-01-01

Point-of-care or point-of-use diagnostics are analytical devices that provide clinically relevant information without the need for a core clinical laboratory. In this review we define point-of-care diagnostics as portable versions of assays performed in a traditional clinical chemistry laboratory. This review discusses five areas relevant to human and animal health where increased attention could produce significant impact: veterinary medicine, space travel, sports medicine, emergency medicine, and operating room efficiency. For each of these areas, clinical need, available commercial products, and ongoing research into new devices are highlighted. PMID:26837054

Laboratory Tests

MedlinePlus

... Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Medical Devices Home Medical Devices Products and Medical Procedures In Vitro Diagnostics Tests Used In Clinical Care Tests Used In Clinical Care ...

21 CFR 872.1500 - Gingival fluid measurer.

Code of Federal Regulations, 2012 CFR

2012-04-01

...) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1500 Gingival fluid measurer. (a) Identification... sulcus (depression between the tooth and gums) to determine if there is a gingivitis condition. (b...

21 CFR 872.1500 - Gingival fluid measurer.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1500 Gingival fluid measurer. (a) Identification... sulcus (depression between the tooth and gums) to determine if there is a gingivitis condition. (b...

21 CFR 872.1500 - Gingival fluid measurer.

Code of Federal Regulations, 2013 CFR

2013-04-01

...) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1500 Gingival fluid measurer. (a) Identification... sulcus (depression between the tooth and gums) to determine if there is a gingivitis condition. (b...

21 CFR 886.1385 - Polymethylmethacrylate (PMMA) diagnostic contact lens.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Polymethylmethacrylate (PMMA) diagnostic contact... Polymethylmethacrylate (PMMA) diagnostic contact lens. (a) Identification. A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time...

21 CFR 886.1385 - Polymethylmethacrylate (PMMA) diagnostic contact lens.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Polymethylmethacrylate (PMMA) diagnostic contact... Polymethylmethacrylate (PMMA) diagnostic contact lens. (a) Identification. A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time...

An Experimental Study of the Plasma Focus Device as a Charged Particle Accelerator

DTIC Science & Technology

1988-11-01

The dense plasma focus has been investigated at many laboratories as a possible fusion device. Typical plasma parameters for this device are electron...temperatures of 1 keV, densities of 10 to the 19th power per cc, and confinement times of 100 ns. Characteristic of the plasma focus discharge are...neutrons. The emphasis of this work is to investigate the electron and ion emission from the plasma focus and the development of appropriate diagnostics to

Smartphones, tablets and mobile applications for radiology.

PubMed

Székely, András; Talanow, Roland; Bágyi, Péter

2013-05-01

Smartphones are phone devices that may also be used for browsing, navigation and running smaller computer programs called applications. One may consider them as compact personal computers which are primarily to be used for making phone calls. Tablets or "tablet PCs" are fully functioning standalone computers the size of a thin LCD monitor that use the screen itself for control and data input. Both of these devices may be categorized based on the mobile operating system that they use. The aim of this study is to illustrate how smartphones and tablets can be used by diagnostic imaging professionals, radiographers and residents, and to introduce relevant applications that are available for their field. A search was performed on iTunes, Android Market, Blackberry App World, and Windows Phone Marketplace for mobile applications pertinent to the field of diagnostic imaging. The following terms were applied for the search strategy: (1) radiology, (2) X-ray, (3) ultrasound, (4) MRI, (5) CT, (6) radiographer, (7) nuclear medicine. Two radiologists and one radiology resident reviewed the results. Our review was limited to english-language software. Additional applications were identified by reviewing the list of similar software provided in the description of each application. We downloaded and installed all applications that appeared relevant to an appropriate mobile phone or tablet device. We identified and reviewed a total of 102 applications. We ruled out 1 non-English application and 20 other applications that were created for entertainment purposes. Thus our final list includes 81 applications in the following five categories: diagnostic reading, decision support applications, medical books, interactive encyclopedias, and journal reading programs. Smartphones and tablets offer new opportunities for diagnostic imaging practitioners; these easy-to-use devices equipped with excellent display may be used for diagnostic reading, reference, learning, consultation, and for communication with patients. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Soft x-ray pinhole imaging diagnostics for compact toroid plasmas

NASA Astrophysics Data System (ADS)

Crawford, E. A.; Taggart, D. P.; Bailey, A. D., III

1990-10-01

Soft x-ray pinhole imaging has recently become established as a valuable diagnostic for visualization of field reversed configuration (FRC) plasmas in the TRX-2, FRX-C/LSM devices. Gated MCP image converter devices with CsI cathodes and Be filters with a peak response around 11 nm wavelength are used for exposure durations ranging from a few tenths up to several microseconds. Results of experiments with single and Chevron channel plates are discussed along with estimates of linear exposure limitations with both film and CCD cameras as recording media. Plans for multiframe devices on the FRX-C/LSM and the LSX devices are also discussed.

21 CFR 882.1560 - Skin potential measurement device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Skin potential measurement device. 882.1560 Section 882.1560 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1560 Skin potential...

21 CFR 882.1620 - Intracranial pressure monitoring device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Intracranial pressure monitoring device. 882.1620 Section 882.1620 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1620 Intracranial...

21 CFR 882.1620 - Intracranial pressure monitoring device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Intracranial pressure monitoring device. 882.1620 Section 882.1620 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1620 Intracranial...

21 CFR 882.1540 - Galvanic skin response measurement device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Galvanic skin response measurement device. 882.1540 Section 882.1540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1540...

21 CFR 892.2020 - Medical image communications device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical image communications device. 892.2020 Section 892.2020 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications...

21 CFR 886.1770 - Manual refractor.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1770 Manual refractor. (a) Identification. A manual refractor is a device that is a set of lenses of varous dioptric powers intended to measure the refractive error of the eye. (b) Classification. Class I (general controls). The device is exempt from the...

An Integrated Quantum Dot Barcode Smartphone Optical Device for Wireless Multiplexed Diagnosis of Infected Patients

NASA Astrophysics Data System (ADS)

Ming, Kevin

Integrating mobile-cellular devices with multiplex molecular diagnostics can potentially provide the most powerful platform for tracking, managing and preventing the transmission of infectious diseases. With over 6.9 billion subscriptions globally, handheld mobile-cellular devices can be programmed to spatially map, temporally track, and transmit information on infections over wide geographical space and boundaries. Current cell phone diagnostic technologies have poor limit of detection, dynamic range, and cannot detect multiple pathogen targets simultaneously, limiting their utility to single infections with high load. Here we combined recent advances in quantum dot barcode technology for molecular detection with smartphones to engineer a simple and low-cost chip-based wireless multiplex diagnostic device. We validated our device using a variety of synthetic genomic targets for the respiratory virus and blood-borne pathogens, and demonstrated that it could detect clinical samples after simple amplification. More importantly, we confirmed that the device is capable of detecting patients infected with a single or multiple infectious pathogens (e.g., HIV and hepatitis B) in a single test. This device advances the capacity for global surveillance of infectious diseases and has the potential to accelerate knowledge exchange-transfer of emerging or exigent disease threats with healthcare and military organizations in real-time.

Colorimetric assay for urinary track infection disease diagnostic on flexible substrate

NASA Astrophysics Data System (ADS)

Safavieh, Mohammadali; Ahmed, Minhaz Uddin; Zourob, Mohammed

2012-10-01

We are presenting cassette as a novel point of care diagnostic device. This device is easy to use, low cost to prepare, high throughput and can analyze several samples at the same time. We first, demonstrate the preparation method of the device. Then, fabrication of the flexible substrate has been presented. The device has been used for detection of the real sample of E.coli bacteria following by colorimetric detection. We have shown that we could detect 30 cfu/ml bacteria and 100 fg/μl of Staphylococous aureus DNA in 1 hr using LAMP amplification technique. This device will be helpful in hospitals and doctor's office for analysis of several patients' samples at the same time.

Synthetic biology devices for in vitro and in vivo diagnostics.

PubMed

Slomovic, Shimyn; Pardee, Keith; Collins, James J

2015-11-24

There is a growing need to enhance our capabilities in medical and environmental diagnostics. Synthetic biologists have begun to focus their biomolecular engineering approaches toward this goal, offering promising results that could lead to the development of new classes of inexpensive, rapidly deployable diagnostics. Many conventional diagnostics rely on antibody-based platforms that, although exquisitely sensitive, are slow and costly to generate and cannot readily confront rapidly emerging pathogens or be applied to orphan diseases. Synthetic biology, with its rational and short design-to-production cycles, has the potential to overcome many of these limitations. Synthetic biology devices, such as engineered gene circuits, bring new capabilities to molecular diagnostics, expanding the molecular detection palette, creating dynamic sensors, and untethering reactions from laboratory equipment. The field is also beginning to move toward in vivo diagnostics, which could provide near real-time surveillance of multiple pathological conditions. Here, we describe current efforts in synthetic biology, focusing on the translation of promising technologies into pragmatic diagnostic tools and platforms.

Synthetic biology devices for in vitro and in vivo diagnostics

PubMed Central

Slomovic, Shimyn; Pardee, Keith; Collins, James J.

2015-01-01

There is a growing need to enhance our capabilities in medical and environmental diagnostics. Synthetic biologists have begun to focus their biomolecular engineering approaches toward this goal, offering promising results that could lead to the development of new classes of inexpensive, rapidly deployable diagnostics. Many conventional diagnostics rely on antibody-based platforms that, although exquisitely sensitive, are slow and costly to generate and cannot readily confront rapidly emerging pathogens or be applied to orphan diseases. Synthetic biology, with its rational and short design-to-production cycles, has the potential to overcome many of these limitations. Synthetic biology devices, such as engineered gene circuits, bring new capabilities to molecular diagnostics, expanding the molecular detection palette, creating dynamic sensors, and untethering reactions from laboratory equipment. The field is also beginning to move toward in vivo diagnostics, which could provide near real-time surveillance of multiple pathological conditions. Here, we describe current efforts in synthetic biology, focusing on the translation of promising technologies into pragmatic diagnostic tools and platforms. PMID:26598662

INVESTIGATIONS ON BABIES AND EXPECTANT MOTHERS WITH REDUCED DOSES OF RADIOISOTOPES

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hosain, F.

1960-02-01

Sensitive instruments, low-level counting devices, and short-lived isotopes are recommended for diagnostic tracer studies with radioisotopes in babies and expectant, mothers. Results are tabulated from studies using iodine131 and iron-59. (C.H.)

21 CFR 876.1735 - Electrogastrography system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Electrogastrography system. 876.1735 Section 876...) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Diagnostic Devices § 876.1735 Electrogastrography system. (a) Identification. An electrogastrography system (EGG) is a device used to measure gastric...

Prosthetic Device Infections.

PubMed

Martinez, Raquel M; Bowen, Thomas R; Foltzer, Michael A

2016-08-01

The immunocompromised host is a particularly vulnerable population in whom routine and unusual infections can easily and frequently occur. Prosthetic devices are commonly used in these patients and the infections associated with those devices present a number of challenges for both the microbiologist and the clinician. Biofilms play a major role in device-related infections, which may contribute to failed attempts to recover organisms from routine culture methods. Moreover, device-related microorganisms can be difficult to eradicate by antibiotic therapy alone. Changes in clinical practice and advances in laboratory diagnostics have provided significant improvements in the detection and accurate diagnosis of device-related infections. Disruption of the bacterial biofilm plays an essential role in recovering the causative agent in culture. Various culture and nucleic acid amplification techniques are more accurate to guide directed treatment regimens. This chapter reviews the performance characteristics of currently available diagnostic assays and summarizes published guidelines, where available, for addressing suspected infected prosthetic devices.

A NEW HEALTH TECHNOLOGY ASSESSMENT SYSTEM FOR DEVICES: THE FIRST FIVE YEARS.

PubMed

Campbell, Bruce; Dobson, Lee; Higgins, Joanne; Dillon, Bernice; Marlow, Mirella; Pomfrett, Chris

2017-01-01

The aim of this study was to review 5 years of activity from a new system devised by the National Institute for Health and Care Excellence (NICE), for assessing medical devices and diagnostics aimed at identifying and speeding adoption of technologies with clinical and cost advantages, compared with current practice in the United Kingdom healthcare system. All eligible notified technologies were classified using the Food and Drug Administration and Global Medical Device Nomenclature nomenclatures. Decisions about selecting technologies for full assessment to produce NICE recommendations were reviewed, along with the reasons given to companies for not selecting products. Between 2009 and 2014, 186 technologies were notified (46 percent therapeutic and 54 percent diagnostic). Thirty-nine were judged ineligible (no regulatory approval), and 147 were considered by an independent committee. Of these, eighty (54 percent) were not selected for full assessment, most commonly because of insufficient evidence (86 percent): there were uncertainties specifically about benefits to the health service (54 percent), to patients (39 percent), and about cost (24 percent). The remaining 67 were selected and assessed for Medical Technology guidance (52 percent) (noninferior and/or lower cost consequences than current practice), for Diagnostics guidance (43 percent) or other NICE recommendations about adoption and use. Classifying technologies by two different systems showed no selection bias for any technology type or disease area. Identifying new or under-used devices and diagnostics with potential benefits and promoting their adoption is important to health services in the United Kingdom and worldwide. This new system offers a means of fostering both uptake and further research. Lack of research data on new products is a major obstacle to evaluation.

Home Use Tests

MedlinePlus

... Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Medical Devices Home Medical Devices Products and Medical Procedures In Vitro Diagnostics Home Use Tests Home Use Tests Share Tweet Linkedin Pin it ...

Compact soft x-ray multichord camera: Design and initial operation

NASA Astrophysics Data System (ADS)

Franz, P.; Gadani, G.; Pasqualotto, R.; Marrelli, L.; Martin, P.; Spizzo, G.; Brunsell, P.; Chapman, B. E.; Paganucci, F.; Rossetti, P.; Xiao, C.

2003-03-01

A compact and low cost diagnostic for spatially resolved measurements of soft x-ray or total radiation emission has been designed and realized to be flexibly applied to different plasma physics experiments. Its reduced size (outer diameter=35 mm) makes it suited to a variety of devices. The line integrated emissivity (brightness) has been measured along up to 20 lines of sight, using an array of miniaturized silicon photodiodes. Preliminary prototypes of the diagnostic have been installed in the Madison Symmetric Torus reversed field pinch (RFP) device at University of Wisconsin and in the EXTRAP T2 RFP device at the Royal Institute of Technology in Stockholm. Application of the diagnostic to a gas-fed (argon, helium) magnetoplasma dynamic thruster (MPDT) with an external magnetic field will also be discussed.

21 CFR 882.1570 - Powered direct-contact temperature measurement device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Powered direct-contact temperature measurement device. 882.1570 Section 882.1570 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882...

21 CFR 882.1570 - Powered direct-contact temperature measurement device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Powered direct-contact temperature measurement device. 882.1570 Section 882.1570 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882...

21 CFR 882.1550 - Nerve conduction velocity measurement device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Nerve conduction velocity measurement device. 882.1550 Section 882.1550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1550 Nerve...

21 CFR 882.1550 - Nerve conduction velocity measurement device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Nerve conduction velocity measurement device. 882.1550 Section 882.1550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1550 Nerve...

21 CFR 886.1500 - Headband mirror.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1500 Headband mirror. (a) Identification. A headband mirror is a device intended to be strapped to the head of the user to reflect light for use in examination of the eye. (b) Classification. Class I (general controls). The device is exempt from the...

21 CFR 872.1800 - Extraoral source x-ray system.

Code of Federal Regulations, 2011 CFR

2011-04-01

... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1800 Extraoral source x-ray system. (a... dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x...

21 CFR 872.1800 - Extraoral source x-ray system.

Code of Federal Regulations, 2014 CFR

2014-04-01

... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1800 Extraoral source x-ray system. (a... dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x...

21 CFR 872.1810 - Intraoral source x-ray system.

Code of Federal Regulations, 2014 CFR

2014-04-01

... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1810 Intraoral source x-ray system. (a... intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral...

A Paper-Based Device for Performing Loop-Mediated Isothermal Amplification with Real-Time Simultaneous Detection of Multiple DNA Targets.

PubMed

Seok, Youngung; Joung, Hyou-Arm; Byun, Ju-Young; Jeon, Hyo-Sung; Shin, Su Jeong; Kim, Sanghyo; Shin, Young-Beom; Han, Hyung Soo; Kim, Min-Gon

2017-01-01

Paper-based diagnostic devices have many advantages as a one of the multiple diagnostic test platforms for point-of-care (POC) testing because they have simplicity, portability, and cost-effectiveness. However, despite high sensitivity and specificity of nucleic acid testing (NAT), the development of NAT based on a paper platform has not progressed as much as the others because various specific conditions for nucleic acid amplification reactions such as pH, buffer components, and temperature, inhibitions from technical differences of paper-based device. Here, we propose a paper-based device for performing loop-mediated isothermal amplification (LAMP) with real-time simultaneous detection of multiple DNA targets. We determined the optimal chemical components to enable dry conditions for the LAMP reaction without lyophilization or other techniques. We also devised the simple paper device structure by sequentially stacking functional layers, and employed a newly discovered property of hydroxynaphthol blue fluorescence to analyze real-time LAMP signals in the paper device. This proposed platform allowed analysis of three different meningitis DNA samples in a single device with single-step operation. This LAMP-based multiple diagnostic device has potential for real-time analysis with quantitative detection of 10 2 -10 5 copies of genomic DNA. Furthermore, we propose the transformation of DNA amplification devices to a simple and affordable paper system approach with great potential for realizing a paper-based NAT system for POC testing.

A Paper-Based Device for Performing Loop-Mediated Isothermal Amplification with Real-Time Simultaneous Detection of Multiple DNA Targets

PubMed Central

Seok, Youngung; Joung, Hyou-Arm; Byun, Ju-Young; Jeon, Hyo-Sung; Shin, Su Jeong; Kim, Sanghyo; Shin, Young-Beom; Han, Hyung Soo; Kim, Min-Gon

2017-01-01

Paper-based diagnostic devices have many advantages as a one of the multiple diagnostic test platforms for point-of-care (POC) testing because they have simplicity, portability, and cost-effectiveness. However, despite high sensitivity and specificity of nucleic acid testing (NAT), the development of NAT based on a paper platform has not progressed as much as the others because various specific conditions for nucleic acid amplification reactions such as pH, buffer components, and temperature, inhibitions from technical differences of paper-based device. Here, we propose a paper-based device for performing loop-mediated isothermal amplification (LAMP) with real-time simultaneous detection of multiple DNA targets. We determined the optimal chemical components to enable dry conditions for the LAMP reaction without lyophilization or other techniques. We also devised the simple paper device structure by sequentially stacking functional layers, and employed a newly discovered property of hydroxynaphthol blue fluorescence to analyze real-time LAMP signals in the paper device. This proposed platform allowed analysis of three different meningitis DNA samples in a single device with single-step operation. This LAMP-based multiple diagnostic device has potential for real-time analysis with quantitative detection of 102-105 copies of genomic DNA. Furthermore, we propose the transformation of DNA amplification devices to a simple and affordable paper system approach with great potential for realizing a paper-based NAT system for POC testing. PMID:28740546

Improved impression cytology techniques for the immunopathological diagnosis of superficial viral infections

PubMed Central

Thiel, M; Bossart, W; Bernauer, W

1997-01-01

BACKGROUND—For epidemiological and therapeutic reasons early diagnosis of superficial viral infections is crucial. Conventional microbiological techniques are expensive, time consuming, and not sufficiently sensitive. In this study impression cytology techniques were evaluated to analyse their diagnostic potential in viral infections of the ocular surface.
METHOD—A Biopore membrane device instead of the original impression cytology technique was used to allow better quality and handling of the specimens. The impressions were processed, using monoclonal antibodies and immunoperoxidase or immunofluorescence techniques to assess the presence of herpes simplex virus, varicella zoster virus, or adenovirus antigens. Ocular surface specimens from healthy individuals (n=10) and from patients with suspected viral surface disease (n=19) were studied. Infected and non-infected cell cultures served as controls.
RESULTS—This modified technique of impression cytology allowed the collection of large conjunctival and corneal epithelial cell layers with excellent morphology. Immunocytological staining of these samples provided diagnostic results for all three viruses in patients with viral surface disease.
CONCLUSIONS—The use of Biopore membrane devices for the collection of ocular surface epithelia offers new diagnostic possibilities for external eye diseases. Immunopathological methods that are applied directly on these membrane devices can provide virological results within 1-4 hours. This contributes considerably to the clinical management of patients with infectious diseases of the ocular surface.

 PMID:9505824

21 CFR 801.119 - In vitro diagnostic products.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false In vitro diagnostic products. 801.119 Section 801...) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.119 In vitro diagnostic products. A product intended for use in the diagnosis of disease and which is an in vitro diagnostic...

21 CFR 809.20 - General requirements for manufacturers and producers of in vitro diagnostic products.

Code of Federal Regulations, 2010 CFR

2010-04-01

... producers of in vitro diagnostic products. 809.20 Section 809.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN... producers of in vitro diagnostic products. (a) [Reserved] (b) Compliance with good manufacturing practices...

21 CFR 809.20 - General requirements for manufacturers and producers of in vitro diagnostic products.

Code of Federal Regulations, 2011 CFR

2011-04-01

... producers of in vitro diagnostic products. 809.20 Section 809.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN... producers of in vitro diagnostic products. (a) [Reserved] (b) Compliance with good manufacturing practices...

21 CFR 801.119 - In vitro diagnostic products.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false In vitro diagnostic products. 801.119 Section 801...) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.119 In vitro diagnostic products. A product intended for use in the diagnosis of disease and which is an in vitro diagnostic...

21 CFR 1020.30 - Diagnostic x-ray systems and their major components.

Code of Federal Regulations, 2012 CFR

2012-04-01

... irradiation. Diagnostic source assembly means the tube housing assembly with a beam-limiting device attached. Diagnostic x-ray system means an x-ray system designed for irradiation of any part of the human body for the... diagnostic source assembly. Fluoroscopic irradiation time means the cumulative duration during an examination...

21 CFR 1020.30 - Diagnostic x-ray systems and their major components.

Code of Federal Regulations, 2013 CFR

2013-04-01

... irradiation. Diagnostic source assembly means the tube housing assembly with a beam-limiting device attached. Diagnostic x-ray system means an x-ray system designed for irradiation of any part of the human body for the... diagnostic source assembly. Fluoroscopic irradiation time means the cumulative duration during an examination...

21 CFR 1020.30 - Diagnostic x-ray systems and their major components.

Code of Federal Regulations, 2014 CFR

2014-04-01

... irradiation. Diagnostic source assembly means the tube housing assembly with a beam-limiting device attached. Diagnostic x-ray system means an x-ray system designed for irradiation of any part of the human body for the... diagnostic source assembly. Fluoroscopic irradiation time means the cumulative duration during an examination...

47 CFR 95.1209 - Permissible communications.

Code of Federal Regulations, 2010 CFR

2010-10-01

... PERSONAL RADIO SERVICES Medical Device Radiocommunication Service (MedRadio) § 95.1209 Permissible..., diagnostic and therapeutic information associated with a medical implant device or medical body-worn device... that is not included with a medical implant or medical body-worn device. Wireless retransmission of...

21 CFR 886.1460 - Stereopsis measuring instrument.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Stereopsis measuring instrument. 886.1460 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1460 Stereopsis measuring instrument. (a) Identification. A stereopsis measuring instrument is a device intended to measure depth...

21 CFR 886.1760 - Ophthalmic refractometer.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1760 Ophthalmic refractometer. (a) Identification. An ophthalmic refractometer is an automatic AC-powered device that consists of a fixation system... of the eye by measuring light reflexes from the retina. (b) Classification. Class I (general controls...

21 CFR 892.1410 - Nuclear electrocardiograph synchronizer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Nuclear electrocardiograph synchronizer. 892.1410... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1410 Nuclear electrocardiograph synchronizer. (a) Identification. A nuclear electrocardiograph synchronizer is a device intended for use in...

21 CFR 892.1410 - Nuclear electrocardiograph synchronizer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Nuclear electrocardiograph synchronizer. 892.1410... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1410 Nuclear electrocardiograph synchronizer. (a) Identification. A nuclear electrocardiograph synchronizer is a device intended for use in...

21 CFR 892.1410 - Nuclear electrocardiograph synchronizer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Nuclear electrocardiograph synchronizer. 892.1410... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1410 Nuclear electrocardiograph synchronizer. (a) Identification. A nuclear electrocardiograph synchronizer is a device intended for use in...

21 CFR 892.1410 - Nuclear electrocardiograph synchronizer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Nuclear electrocardiograph synchronizer. 892.1410... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1410 Nuclear electrocardiograph synchronizer. (a) Identification. A nuclear electrocardiograph synchronizer is a device intended for use in...

21 CFR 892.1410 - Nuclear electrocardiograph synchronizer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nuclear electrocardiograph synchronizer. 892.1410... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1410 Nuclear electrocardiograph synchronizer. (a) Identification. A nuclear electrocardiograph synchronizer is a device intended for use in...

Developing system for delivery of optical radiation in medicobiological researches

NASA Astrophysics Data System (ADS)

Loschenov, Victor B.; Taraz, Majid

2004-06-01

Methods of optical diagnostics and methods of photodynamic therapy are actively used in medico-biological researches. The system for delivery of optical radiation is one of the key methods in these researches. Usually these systems use flexible optical fibers with diameters from 200 to 1000 micron. Two types of systems for delivery are subdivided, first for diagnostic researches, second for therapeutic procedures. Existing diagnostic catheters, which have most widely applied in medicine, have bifurcated with diameter of the tip equal 1.8 mm. These devices, which are called fiber-optical catheters, satisfy the majority endoscopes researches. However, till now the problem of optical-diagnostics inside tissue is not soled. Especially it is important at diagnostics of a mammary gland, livers, thyroid glands tumor, tumor of a brain and some other studies connected with punctures. In these cases, it is necessary that diameter of fiber-optical catheters be less than one millimeter. This work is devoted to the development of these catheters. Also in clinical procedures such as photodynamic therapy (PDT) and interstitial laser photocoagulation (ILP), cylindrical light diffusing tips are rapidly becoming a popular device for the administration of the desired light dose for the illumination of hollow organs, such as bronchus, trachea and oesophagus. This work is devoted to the development of these catheters.

Head-Impact-Measurement Devices: A Systematic Review.

PubMed

O'Connor, Kathryn L; Rowson, Steven; Duma, Stefan M; Broglio, Steven P

2017-03-01

With an estimated 3.8 million sport- and recreation-related concussions occurring annually, targeted prevention and diagnostic methods are needed. Biomechanical analysis of head impacts may provide quantitative information that can inform both prevention and diagnostic strategies. To assess available head-impact devices and their clinical utility. We performed a systematic search of the electronic database PubMed for peer-reviewed publications, using the following phrases: accelerometer and concussion, head impact telemetry, head impacts and concussion and sensor, head impacts and sensor, impact sensor and concussion, linear acceleration and concussion, rotational acceleration and concussion, and xpatch concussion. In addition to the literature review, a Google search for head impact monitor and concussion monitor yielded 15 more devices. Included studies were performed in vivo, used commercially available devices, and focused on sport-related concussion. One author reviewed the title and abstract of each study for inclusion and exclusion criteria and then reviewed each full-text article to confirm inclusion criteria. Controversial articles were reviewed by all authors to reach consensus. In total, 61 peer-reviewed articles involving 4 head-impact devices were included. Participants in boxing, football, ice hockey, soccer, or snow sports ranged in age from 6 to 24 years; 18% (n = 11) of the studies included female athletes. The Head Impact Telemetry System was the most widely used device (n = 53). Fourteen additional commercially available devices were presented. Measurements collected by impact monitors provided real-time data to estimate player exposure but did not have the requisite sensitivity to concussion. Proper interpretation of previously reported head-impact kinematics across age, sport, and position may inform future research and enable staff clinicians working on the sidelines to monitor athletes. However, head-impact-monitoring systems have limited clinical utility due to error rates, designs, and low specificity in predicting concussive injury.

System theory in medical diagnostic devices: an overview.

PubMed

Baura, Gail D

2006-01-01

Medical diagnostics refers to testing conducted either in vitro or in vivo to provide critical health care information for risk assessment, early diagnosis, treatment, or disease management. Typical in vivo diagnostic tests include the computed tomography scan, magnetic resonance imaging, and blood pressure screening. Typical in vitro diagnostic tests include cholesterol, Papanicolaou smear, and conventional glucose monitoring tests. Historically, devices associated with both types of diagnostics have used heuristic curve fitting during signal analysis. However, since the early 1990s, a few enterprising engineers and physicians have used system theory to improve their core processing for feature detection and system identification. Current applications include automated Pap smear screening for detection of cervical cancer and diagnosis of Alzheimer's disease. Future applications, such as disease prediction before symptom onset and drug treatment customization, have been catalyzed by the Human Genome Project.

Mechanical phenotyping of tumor cells using a microfluidic cell squeezer device

NASA Astrophysics Data System (ADS)

Khan, Zeina S.; Kamyabi, Nabiollah; Vanapalli, Siva A.

2013-03-01

Studies have indicated that cancer cells have distinct mechanical properties compared to healthy cells. We are investigating the potential of cell mechanics as a biophysical marker for diagnostics and prognosis of cancer. To establish the significance of mechanical properties for cancer diagnostics, a high throughput method is desired. Although techniques such as atomic force microscopy are very precise, they are limited in throughput for cellular mechanical property measurements. To develop a device for high throughput mechanical characterization of tumor cells, we have fabricated a microfludic cell squeezer device that contains narrow micrometer-scale pores. Fluid flow is used to drive cells into these pores mimicking the flow-induced passage of circulating tumor cells through microvasculature. By integrating high speed imaging, the device allows for the simultaneous characterization of five different parameters including the blockage pressure, cell velocity, cell size, elongation and the entry time into squeezer. We have tested a variety of in vitro cell lines, including brain and prostate cancer cell lines, and have found that the entry time is the most sensitive measurement capable of differentiating between cell lines with differing invasiveness.

[Infectious complications of long term intravenous devices: incidence, risk factors, diagnostic tools].

PubMed

Douard, M C; Ardoin, C; Payri, L; Tarot, J P

1999-03-01

Implantable venous ports and Hickman central venous catheters are widely used in patients with cancer, blood disorders, or HIV infection, both for in-hospital care and at home. Infectious complications are among the common causes for readmission in these patients. The present review discusses the incidence, risk factors, and diagnostic tools for infectious complications associated with long-term venous access devices.

Diagnostic yield of device interrogation in the evaluation of syncope in an elderly population.

PubMed

D'Angelo, Robert N; Pickett, Christopher C

2017-06-01

Device interrogation has become a standard part of the syncope evaluation for patients admitted with permanent pacemakers (PPM) or implantable cardiac defibrillators (ICD), although few studies have shown interrogation yields clinically useful data. The purpose of this study is to determine the diagnostic yield of device interrogation as well as other commonly performed tests in the workup of unexplained syncope in patients with previously implanted PPMs or ICDs. We retrospectively reviewed records of 88 patients admitted to our medical center for syncope with previously implanted pacemakers between January 1, 2005 and January 1, 2015 using ICD-9 billing data. Pacemaker interrogation demonstrated an arrhythmia as the cause for syncope in 4 patients (4%) and evidence of device failure secondary to perforation in 1 patient (1%). The cause of syncope was unknown in 34 patients (39%). Orthostatic hypotension was the most commonly identified cause of syncope (26%), followed by vasovagal syncope (13%), autonomic dysfunction (5%), ventricular arrhythmia (3%), atrial arrhythmia (2%), congestive heart failure (2%), stroke (2%), and other less common causes (8%). History was the most important determinant of syncope (36%), followed by orthostatic vital signs (14%), device interrogations (4%), head CT (2%), and transthoracic echocardiogram (1%). Device interrogation is rarely useful for elucidating a cause of syncope without concerning physical exam, telemetry, or EKG findings. Interrogation may occasionally yield paroxysmal arrhythmias responsible for syncopal episode, but these rarely alter clinical outcomes. Interrogation appears to be more useful in patients with syncope after recent device placement. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

Electromagnetic Nanoparticles for Sensing and Medical Diagnostic Applications

PubMed Central

Vegni, Lucio

2018-01-01

A modeling and design approach is proposed for nanoparticle-based electromagnetic devices. First, the structure properties were analytically studied using Maxwell’s equations. The method provides us a robust link between nanoparticles electromagnetic response (amplitude and phase) and their geometrical characteristics (shape, geometry, and dimensions). Secondly, new designs based on “metamaterial” concept are proposed, demonstrating great performances in terms of wide-angle range functionality and multi/wide behavior, compared to conventional devices working at the same frequencies. The approach offers potential applications to build-up new advanced platforms for sensing and medical diagnostics. Therefore, in the final part of the article, some practical examples are reported such as cancer detection, water content measurements, chemical analysis, glucose concentration measurements and blood diseases monitoring. PMID:29652853

Thermic sealing in femoral catheterisation: First experience with the Secure Device.

PubMed

Sacherer, Michael; Kolesnik, Ewald; von Lewinski, Friederike; Verheyen, Nicolas; Brandner, Karin; Wallner, Markus; Eaton, Deborah M; Luha, Olev; Zweiker, Robert; von Lewinski, Dirk

2018-04-03

Devices currently used to achieve hemostasis of the femoral artery following percutaneous cardiac catheterization are associated with vascular complications and remnants of artificial materials are retained at the puncture site. The SECURE arterial closure device induces hemostasis by utilizing thermal energy, which causes collagen shrinking and swelling. In comparison to established devices, it has the advantage of leaving no foreign material in the body following closing. This study was designed to evaluate the efficacy and safety of the SECURE device to close the puncture site following percutaneous cardiac catheterization. The SECURE device was evaluated in a prospective non-randomized single-centre trial with patients undergoing 6 F invasive cardiac procedures. A total of 67 patients were enrolled and the device was utilized in 63 patients. 50 diagnostic and 13 interventional cases were evaluated. Femoral artery puncture closure was performed immediately after completion of the procedure. Time to hemostasis (TTH), time to ambulation (TTA) and data regarding short-term and 30-day clinical follow-up were recorded. Mean TTH was 4:30 ± 2:15 min in the overall observational group. A subpopulation of patients receiving anticoagulants had a TTH of 4:53 ± 1:43 min. There were two access site complications (hematoma > 5 cm). No major adverse events were identified during hospitalization or at the 30 day follow-up. The new SECURE device demonstrates that it is feasible in diagnostic and interventional cardiac catheterization. With respect to safety, the SECURE device was non-inferior to other closure devices as tested in the ISAR closure trial.

21 CFR 872.1850 - Lead-lined position indicator.

Code of Federal Regulations, 2014 CFR

2014-04-01

... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1850 Lead-lined position indicator. (a... dental x-ray tube and intended to aid in positioning the tube, to prevent the misfocusing of the x-rays...

A multispectral imaging approach for diagnostics of skin pathologies

NASA Astrophysics Data System (ADS)

Lihacova, Ilze; Derjabo, Aleksandrs; Spigulis, Janis

2013-06-01

Noninvasive multispectral imaging method was applied for different skin pathology such as nevus, basal cell carcinoma, and melanoma diagnostics. Developed melanoma diagnostic parameter, using three spectral bands (540 nm, 650 nm and 950 nm), was calculated for nevus, melanoma and basal cell carcinoma. Simple multispectral diagnostic device was established and applied for skin assessment. Development and application of multispectral diagnostics method described further in this article.

Development of two color laser diagnostics for the ITER poloidal polarimeter.

PubMed

Kawahata, K; Akiyama, T; Tanaka, K; Nakayama, K; Okajima, S

2010-10-01

Two color laser diagnostics using terahertz laser sources are under development for a high performance operation of the Large Helical Device and for future fusion devices such as ITER. So far, we have achieved high power laser oscillation lines simultaneously oscillating at 57.2 and 47.7 μm by using a twin optically pumped CH(3)OD laser, and confirmed the original function, compensation of mechanical vibration, of the two color laser interferometer. In this article, application of the two color laser diagnostics to the ITER poloidal polarimeter and recent hardware developments will be described.

Point-of-care diagnostics for niche applications.

PubMed

Cummins, Brian M; Ligler, Frances S; Walker, Glenn M

2016-01-01

Point-of-care or point-of-use diagnostics are analytical devices that provide clinically relevant information without the need for a core clinical laboratory. In this review we define point-of-care diagnostics as portable versions of assays performed in a traditional clinical chemistry laboratory. This review discusses five areas relevant to human and animal health where increased attention could produce significant impact: veterinary medicine, space travel, sports medicine, emergency medicine, and operating room efficiency. For each of these areas, clinical need, available commercial products, and ongoing research into new devices are highlighted. Copyright © 2016 Elsevier Inc. All rights reserved.

Evaluation of Accuracy of DIAGNOdent in Diagnosis of Primary and Secondary Caries in Comparison to Conventional Methods

PubMed Central

Nokhbatolfoghahaie, Hanieh; Alikhasi, Marzieh; Chiniforush, Nasim; Khoei, Farzaneh; Safavi, Nassimeh; Yaghoub Zadeh, Behnoush

2013-01-01

Introduction: Today the prevalence of teeth decays has considerably decreased. Related organizations and institutions mention several reasons for it such as improvement of decay diagnostic equipment and tools which are even capable of detecting caries in their initial stages. This resulted in reduction of costs for patients and remarkable increase in teeth life span. There are many methods for decay diagnostic, like: visual and radiographic methods, devices with fluorescence such as Quantitative light-induced fluorescence (QLF), Vista proof, Laser fluorescence (LF or DIAGNOdent), Fluorescence Camera (FC) and Digital radiography. Although DIAGNOdent is considered a valuable device for decay diagnostic ,there are concerns regarding its efficacy and accuracy. Considering the sensitivity of decaydiagnosis and the exorbitant annual expenses supported by government and people for caries treatment, finding the best method for early caries detection is of the most importance. Numerous studies were performed to compare different diagnostic methods with conflicting results. The objective of this study is a comparative review of the efficiency of DIAGNOdent in comparison to visual methods and radiographic methods in the diagnostic of teeth occlusal surfaces. Methods: Search of PubMed, Google Scholar electronic resources was performed in order to find clinical trials in English in the period between 1998 and 2013. Full texts of only 35 articles were available. Conclusion: Considering the sensitivity and specificity reported in the different studies, it seems that DIAGNOdent is an appropriate modality for caries detection as a complementary method beside other methods and its use alone to obtain treatment plan is not enough. PMID:25606325

21 CFR 892.1940 - Radiologic quality assurance instrument.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Radiologic quality assurance instrument. 892.1940... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1940 Radiologic quality assurance instrument. (a) Identification. A radiologic quality assurance instrument is a device intended for medical...

21 CFR 870.1290 - Steerable catheter control system.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Steerable catheter control system. 870.1290... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1290 Steerable catheter control system. (a) Identification. A steerable catheter control system is a device that is...

21 CFR 870.1290 - Steerable catheter control system.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Steerable catheter control system. 870.1290... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1290 Steerable catheter control system. (a) Identification. A steerable catheter control system is a device that is...

21 CFR 870.1290 - Steerable catheter control system.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Steerable catheter control system. 870.1290... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1290 Steerable catheter control system. (a) Identification. A steerable catheter control system is a device that is...

21 CFR 870.1915 - Thermodilution probe.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Thermodilution probe. 870.1915 Section 870.1915...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1915 Thermodilution probe. (a) Identification. A thermodilution probe is a device that monitors cardiac output by use of...

21 CFR 870.1915 - Thermodilution probe.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Thermodilution probe. 870.1915 Section 870.1915...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1915 Thermodilution probe. (a) Identification. A thermodilution probe is a device that monitors cardiac output by use of...

21 CFR 870.1915 - Thermodilution probe.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Thermodilution probe. 870.1915 Section 870.1915...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1915 Thermodilution probe. (a) Identification. A thermodilution probe is a device that monitors cardiac output by use of...

21 CFR 870.1915 - Thermodilution probe.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Thermodilution probe. 870.1915 Section 870.1915...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1915 Thermodilution probe. (a) Identification. A thermodilution probe is a device that monitors cardiac output by use of...

21 CFR 868.1910 - Esophageal stethoscope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Esophageal stethoscope. 868.1910 Section 868.1910...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1910 Esophageal stethoscope. (a) Identification. An esophageal stethoscope is a nonpowered device that is inserted into a patient's esophagus to...

21 CFR 886.1930 - Tonometer and accessories.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1930 Tonometer and accessories. (a) Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz...

21 CFR 886.1690 - Pupillograph.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1690 Pupillograph. (a) Identification. A pupillograph is an AC-powered device intended to measure the pupil of the eye by reflected light and record the responses of the...

21 CFR 870.1800 - Withdrawal-infusion pump.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Withdrawal-infusion pump. 870.1800 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1800 Withdrawal-infusion pump. (a) Identification. A withdrawal-infusion pump is a device designed to inject accurately drugs...

Intellectual property considerations for molecular diagnostic development with emphasis on companion diagnostics.

PubMed

Glorikian, Harry; Warburg, Richard Jeremy; Moore, Kelly; Malinowski, Jennifer

2018-02-01

The development of molecular diagnostics is a complex endeavor, with multiple regulatory pathways to consider and numerous approaches to development and commercialization. Companion diagnostics, devices which are "essential for the safe and effective use of a corresponding drug or diagnostic product" (see U.S. Food & Drug Administration, In Vitro Diagnostics - Companion Diagnostics, U.S. Dept. of Health & Human Services(2016), available at https://www.fda.gov/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/ucm407297.htm ) and complementary diagnostics, which are more broadly associated with a class of drug, are becoming increasingly important as integral components of the implementation of precision medicine. Areas covered: The following article will highlight the intellectual property ('IP') considerations pertinent to molecular diagnostics development with special emphasis on companion diagnostics. Expert opinion/commentary Summary: For all molecular diagnostics, intellectual property (IP) concerns are of paramount concern, whether the device will be marketed only in the United States or abroad. Taking steps to protect IP at each stage of product development is critical to optimize profitability of a diagnostic product. Also the legal framework around IP protection of diagnostic technologies has been changing over the previous few years and can be expected to continue to change in the foreseeable near future, thus, a comprehensive IP strategy should take into account the fact that changes in the law can be expected.

[Electronic Device for Retinal and Iris Imaging].

PubMed

Drahanský, M; Kolář, R; Mňuk, T

This paper describes design and construction of a new device for automatic capturing of eye retina and iris. This device has two possible ways of utilization - either for biometric purposes (persons recognition on the base of their eye characteristics) or for medical purposes as supporting diagnostic device. eye retina, eye iris, device, acquisition, image.

Microfluidics in Malignant Glioma Research and Precision Medicine

PubMed Central

Logun, Meghan; Zhao, Wujun

2018-01-01

Glioblastoma multiforme (GBM) is an aggressive form of brain cancer that has no effective treatments and a prognosis of only 12–15 months. Microfluidic technologies deliver microscale control of fluids and cells, and have aided cancer therapy as point-of-care devices for the diagnosis of breast and prostate cancers. However, a few microfluidic devices are developed to study malignant glioma. The ability of these platforms to accurately replicate the complex microenvironmental and extracellular conditions prevailing in the brain and facilitate the measurement of biological phenomena with high resolution and in a high-throughput manner could prove useful for studying glioma progression. These attributes, coupled with their relatively simple fabrication process, make them attractive for use as point-of-care diagnostic devices for detection and treatment of GBM. Here, the current issues that plague GBM research and treatment, as well as the current state of the art in glioma detection and therapy, are reviewed. Finally, opportunities are identified for implementing microfluidic technologies into research and diagnostics to facilitate the rapid detection and better therapeutic targeting of GBM. PMID:29780878

Radar analysis of free oscillations of rail for diagnostics defects

NASA Astrophysics Data System (ADS)

Shaydurov, G. Y.; Kudinov, D. S.; Kokhonkova, E. A.; Potylitsyn, V. S.

2018-05-01

One of the tasks of developing and implementing defectoscopy devices is the minimal influence of the human factor in their exploitation. At present, rail inspection systems do not have sufficient depth of rail research, and ultrasonic diagnostics systems need to contact the sensor with the surface being studied, which leads to low productivity. The article gives a comparative analysis of existing noncontact methods of flaw detection, offers a contactless method of diagnostics by excitation of acoustic waves and extraction of information about defects from the frequency of free rail oscillations using the radar method.

Diagnosis of prosthetic joint infection with alpha-defensin using a lateral flow device: a multicentre study.

PubMed

Berger, P; Van Cauter, M; Driesen, R; Neyt, J; Cornu, O; Bellemans, J

2017-09-01

The purpose of this current multicentre study is to analyse the presence of alpha-defensin proteins in synovial fluid using the Synovasure lateral flow device and to determine its diagnostic reliability and accuracy compared with the prosthetic joint infection (PJI) criteria produced by the Musculoskeletal Infection Society (MSIS). A cohort of 121 patients comprising 85 total knee arthroplasties and 36 total hip arthroplasties was prospectively evaluated between May 2015 and June 2016 in three different orthopaedic centres. The tests were performed on patients with a chronically painful prosthesis undergoing a joint aspiration in a diagnostic pathway or during revision surgery. Based on the MSIS criteria, 34 patients (28%) would have had a PJI, and 87 patients had no PJI. Testing with the lateral flow device had a sensitivity of 97.1% (95% confidence intervals (CI) 84.5 to 99.9) and a specificity of 96.6% (95% CI 90.3 to 99.2). The positive predictive value was 91.7% (95% CI 77.7% to 98.3), and the negative predictive value was 98.8% (95% CI 93.6 to 99.9). Receiver operator characteristics analysis demonstrated an area under the curve for the Synovasure test of 0.97 (95% CI 0.93 to 1.00). Our findings suggest that the Synovasure test has an excellent diagnostic performance to confirm or reject the diagnosis of a PJI. The results are promising for the care of the painful or problematic knee and hip joint arthroplasty and the test should be considered as part of the diagnostic toolbox for PJIs. Cite this article: Bone Joint J 2017;99-B:1176-82. ©2017 The British Editorial Society of Bone & Joint Surgery.

Tachycardia detection in ICDs by Boston Scientific : Algorithms, pearls, and pitfalls.

PubMed

Zanker, Norbert; Schuster, Diane; Gilkerson, James; Stein, Kenneth

2016-09-01

The aim of this study was to summarize how implantable cardioverter defibrillators (ICDs) by Boston Scientific sense, detect, discriminate rhythms, and classify episodes. Modern devices include multiple programming selections, diagnostic features, therapy options, memory functions, and device-related history features. Device operation includes logical steps from sensing, detection, discrimination, therapy delivery to history recording. The program is designed to facilitate the application of the device algorithms to the individual patient's clinical needs. Features and functions described in this article represent a selective excerpt by the authors from Boston Scientific publicly available product resources. Programming of ICDs may affect patient outcomes. Patient-adapted and optimized programming requires understanding of device operation and concepts.

21 CFR 809.11 - Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human...

Code of Federal Regulations, 2011 CFR

2011-04-01

... requirements for in vitro diagnostic products for human use held by the Strategic National Stockpile. 809.11... (CONTINUED) MEDICAL DEVICES IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE Labeling § 809.11 Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human use held by the Strategic...

21 CFR 809.11 - Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human...

Code of Federal Regulations, 2010 CFR

2010-04-01

... requirements for in vitro diagnostic products for human use held by the Strategic National Stockpile. 809.11... (CONTINUED) MEDICAL DEVICES IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE Labeling § 809.11 Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human use held by the Strategic...

Mobile phone-based biosensing: An emerging "diagnostic and communication" technology.

PubMed

Quesada-González, Daniel; Merkoçi, Arben

2017-06-15

In this review we discuss recent developments on the use of mobile phones and similar devices for biosensing applications in which diagnostics and communications are coupled. Owing to the capabilities of mobile phones (their cameras, connectivity, portability, etc.) and to advances in biosensing, the coupling of these two technologies is enabling portable and user-friendly analytical devices. Any user can now perform quick, robust and easy (bio)assays anywhere and at any time. Among the most widely reported of such devices are paper-based platforms. Herein we provide an overview of a broad range of biosensing possibilities, from optical to electrochemical measurements; explore the various reported designs for adapters; and consider future opportunities for this technology in fields such as health diagnostics, safety & security, and environment monitoring. Copyright © 2016 Elsevier B.V. All rights reserved.

Advancing Diagnostics to Address Antibacterial Resistance: The Diagnostics and Devices Committee of the Antibacterial Resistance Leadership Group.

PubMed

Tsalik, Ephraim L; Petzold, Elizabeth; Kreiswirth, Barry N; Bonomo, Robert A; Banerjee, Ritu; Lautenbach, Ebbing; Evans, Scott R; Hanson, Kimberly E; Klausner, Jeffrey D; Patel, Robin

2017-03-15

Diagnostics are a cornerstone of the practice of infectious diseases. However, various limitations frequently lead to unmet clinical needs. In most other domains, diagnostics focus on narrowly defined questions, provide readily interpretable answers, and use true gold standards for development. In contrast, infectious diseases diagnostics must contend with scores of potential pathogens, dozens of clinical syndromes, emerging pathogens, rapid evolution of existing pathogens and their associated resistance mechanisms, and the absence of gold standards in many situations. In spite of these challenges, the importance and value of diagnostics cannot be underestimated. Therefore, the Antibacterial Resistance Leadership Group has identified diagnostics as 1 of 4 major areas of emphasis. Herein, we provide an overview of that development, highlighting several examples where innovation in study design, content, and execution is advancing the field of infectious diseases diagnostics. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

21 CFR 886.1850 - AC-powered slitlamp biomicroscope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false AC-powered slitlamp biomicroscope. 886.1850... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1850 AC-powered slitlamp biomicroscope. (a) Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a...

21 CFR 892.1900 - Automatic radiographic film processor.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Automatic radiographic film processor. 892.1900... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1900 Automatic radiographic film processor. (a) Identification. An automatic radiographic film processor is a device intended to be used to...

21 CFR 892.1890 - Radiographic film illuminator.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Radiographic film illuminator. 892.1890 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1890 Radiographic film illuminator. (a) Identification. A radiographic film illuminator is a device containing a visible light source covered with a...

21 CFR 892.1890 - Radiographic film illuminator.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Radiographic film illuminator. 892.1890 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1890 Radiographic film illuminator. (a) Identification. A radiographic film illuminator is a device containing a visible light source covered with a...

21 CFR 892.1900 - Automatic radiographic film processor.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Automatic radiographic film processor. 892.1900... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1900 Automatic radiographic film processor. (a) Identification. An automatic radiographic film processor is a device intended to be used to...

21 CFR 892.1890 - Radiographic film illuminator.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Radiographic film illuminator. 892.1890 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1890 Radiographic film illuminator. (a) Identification. A radiographic film illuminator is a device containing a visible light source covered with a...

21 CFR 892.1900 - Automatic radiographic film processor.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Automatic radiographic film processor. 892.1900... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1900 Automatic radiographic film processor. (a) Identification. An automatic radiographic film processor is a device intended to be used to...

21 CFR 892.1890 - Radiographic film illuminator.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Radiographic film illuminator. 892.1890 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1890 Radiographic film illuminator. (a) Identification. A radiographic film illuminator is a device containing a visible light source covered with a...

21 CFR 892.1900 - Automatic radiographic film processor.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Automatic radiographic film processor. 892.1900... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1900 Automatic radiographic film processor. (a) Identification. An automatic radiographic film processor is a device intended to be used to...

21 CFR 892.1890 - Radiographic film illuminator.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Radiographic film illuminator. 892.1890 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1890 Radiographic film illuminator. (a) Identification. A radiographic film illuminator is a device containing a visible light source covered with a...

21 CFR 892.1900 - Automatic radiographic film processor.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Automatic radiographic film processor. 892.1900... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1900 Automatic radiographic film processor. (a) Identification. An automatic radiographic film processor is a device intended to be used to...

21 CFR 886.1905 - Nystagmus tape.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1905 Nystagmus tape. (a) Identification. Nystagmus tape is a device that is a long, narrow strip of fabric or other flexible material on which a series of objects are...

21 CFR 892.1300 - Nuclear rectilinear scanner.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nuclear rectilinear scanner. 892.1300 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1300 Nuclear rectilinear scanner. (a) Identification. A nuclear rectilinear scanner is a device intended to image the distribution of radionuclides in...

21 CFR 892.1300 - Nuclear rectilinear scanner.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Nuclear rectilinear scanner. 892.1300 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1300 Nuclear rectilinear scanner. (a) Identification. A nuclear rectilinear scanner is a device intended to image the distribution of radionuclides in...

Applications and Methods for Continuous Monitoring of Physiological Chemistry

DTIC Science & Technology

2016-02-04

product and test platform to verify the performance characteristics of the enzymes when used in diagnostic device fabrication. 1.3 Results This...project had three primary objectives: 1. Engineer a cortisol oxidase enzyme suitable for use in diagnostic devices 2. Large scale production and...for both animal and human use , and for direct sale to other entities to manufacture biosensors and other products for human monitoring. The enzymes

Diagnostic abilities of three-dimensional electronic axiography on the basis of ARCUSdigma device.

PubMed

Bakalczuk, Magdalena; Bozyk, Andrzej; Iwanek, Michał; Borowicz, Janusz; Sykut, Janusz; Kleinrok, Janusz

2004-01-01

The ARCUSdigma is an electronic facebow enabling presentation and graphic analysis of mandibular movements on the computer screen. A kinematic hinge axis of the mandible can be determined using this device. The paper presents the diagnostic potential of the ARCUSdigma in relation to programming an articulator according to individual parameters of mandibular movements of the patient and its application in the diagnosis of temporo-mandibular joints.

Development of computer informational system of diagnostics integrated optical materials, elements, and devices

NASA Astrophysics Data System (ADS)

Volosovitch, Anatoly E.; Konopaltseva, Lyudmila I.

1995-11-01

Well-known methods of optical diagnostics, database for their storage, as well as expert system (ES) for their development are analyzed. A computer informational system is developed, which is based on a hybrid ES built on modern DBMS. As an example, the structural and constructive circuits of the hybrid integrated-optical devices based on laser diodes, diffusion waveguides, geodetic lenses, package-free linear photodiode arrays, etc. are presented. The features of methods and test results as well as the advanced directions of works related to the hybrid integrated-optical devices in the field of metrology are discussed.

Modular initiator with integrated optical diagnostic

DOEpatents

Alam, M Kathleen [Cedar Crest, NM; Schmitt, Randal L [Tijeras, NM; Welle, Eric J [Niceville, FL; Madden, Sean P [Arlington, MA

2011-05-17

A slapper detonator which integrally incorporates an optical wavequide structure for determining whether there has been degradation of the explosive in the explosive device that is to be initiated by the detonator. Embodiments of this invention take advantage of the barrel-like character of a typical slapper detonator design. The barrel assembly, being in direct contact with the energetic material, incorporates an optical diagnostic device into the barrel assembly whereby one can monitor the state of the explosive material. Such monitoring can be beneficial because the chemical degradation of the explosive plays an important in achieving proper functioning of a detonator/initiator device.

Generation of Controlled Analog Emissions from Embedded Devices using Software Stress Methods

DTIC Science & Technology

2017-03-01

Generation of Controlled Analog Emissions from Embedded Devices using Software Stress Methods Oren Sternberg, Jonathan H. Nelson, Israel Perez...Abstract: In this paper, we present a new method that uses software diagnostic tools to study the generation of induced spurious physical emissions from...types of attacks warrants an understanding of unwanted signal generation. We examine this connection by observing the emission profile of an embedded

Portable Diagnostics Technology Assessment for Space Missions. Part 1; General Technology Capabilities for NASA Exploration Missions

NASA Technical Reports Server (NTRS)

Nelson, Emily S.; Chait, Arnon

2010-01-01

The changes in the scope of NASA s mission in the coming decade are profound and demand nimble, yet insightful, responses. On-board clinical and environmental diagnostics must be available for both mid-term lunar and long-term Mars exploration missions in an environment marked by scarce resources. Miniaturization has become an obvious focus. Despite solid achievements in lab-based devices, broad-based, robust tools for application in the field are not yet on the market. The confluence of rapid, wide-ranging technology evolution and internal planning needs are the impetus behind this work. This report presents an analytical tool for the ongoing evaluation of promising technology platforms based on mission- and application-specific attributes. It is not meant to assess specific devices, but rather to provide objective guidelines for a rational down-select of general categories of technology platforms. In this study, we have employed our expertise in the microgravity operation of fluidic devices, laboratory diagnostics for space applications, and terrestrial research in biochip development. A rating of the current state of technology development is presented using the present tool. Two mission scenarios are also investigated: a 30-day lunar mission using proven, tested technology in 5 years; and a 2- to 3-year mission to Mars in 10 to 15 years.

Point-of-care testing in the diagnosis of gastrointestinal cancers: Current technology and future directions

PubMed Central

Huddy, Jeremy R; Ni, Melody Z; Markar, Sheraz R; Hanna, George B

2015-01-01

Point-of-care (POC) tests enable rapid results and are well established in medical practice. Recent advances in analytical techniques have led to a new generation of POC devices that will alter gastrointestinal diagnostic pathways. This review aims to identify current and new technologies for the POC diagnosis of gastrointestinal cancer. A structured search of the Embase and Medline databases was performed. Papers reporting diagnostic tests for gastrointestinal cancer available as a POC device or containing a description of feasibility for POC application were included. Studies recovered were heterogeneous and therefore results are presented as a narrative review. Six diagnostic methods were identified (fecal occult blood, fecal proteins, volatile organic compounds, pyruvate kinase isoenzyme type M2, tumour markers and DNA analysis). Fecal occult blood testing has a reported sensitivity of 66%-85% and specificity greater than 95%. The others are at a range of development and clinical application. POC devices have a proven role in the diagnosis of gastrointestinal cancer. Barriers to their implementation exist and the transition from experimental to clinical medicine is currently slow. New technologies demonstrate potential to provide accurate POC tests and an ability to diagnose gastrointestinal cancer at an early stage with improved clinical outcome and survival. PMID:25892860

Point-of-care testing in the diagnosis of gastrointestinal cancers: current technology and future directions.

PubMed

Huddy, Jeremy R; Ni, Melody Z; Markar, Sheraz R; Hanna, George B

2015-04-14

Point-of-care (POC) tests enable rapid results and are well established in medical practice. Recent advances in analytical techniques have led to a new generation of POC devices that will alter gastrointestinal diagnostic pathways. This review aims to identify current and new technologies for the POC diagnosis of gastrointestinal cancer. A structured search of the Embase and Medline databases was performed. Papers reporting diagnostic tests for gastrointestinal cancer available as a POC device or containing a description of feasibility for POC application were included. Studies recovered were heterogeneous and therefore results are presented as a narrative review. Six diagnostic methods were identified (fecal occult blood, fecal proteins, volatile organic compounds, pyruvate kinase isoenzyme type M2, tumour markers and DNA analysis). Fecal occult blood testing has a reported sensitivity of 66%-85% and specificity greater than 95%. The others are at a range of development and clinical application. POC devices have a proven role in the diagnosis of gastrointestinal cancer. Barriers to their implementation exist and the transition from experimental to clinical medicine is currently slow. New technologies demonstrate potential to provide accurate POC tests and an ability to diagnose gastrointestinal cancer at an early stage with improved clinical outcome and survival.

21 CFR 868.1400 - Carbon dioxide gas analyzer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Carbon dioxide gas analyzer. 868.1400 Section 868...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1400 Carbon dioxide gas analyzer. (a) Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide...

21 CFR 868.1400 - Carbon dioxide gas analyzer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Carbon dioxide gas analyzer. 868.1400 Section 868...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1400 Carbon dioxide gas analyzer. (a) Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide...

21 CFR 868.1640 - Helium gas analyzer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Helium gas analyzer. 868.1640 Section 868.1640...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1640 Helium gas analyzer. (a) Identification. A helium gas analyzer is a device intended to measure the concentration of helium in a gas...

21 CFR 868.1640 - Helium gas analyzer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Helium gas analyzer. 868.1640 Section 868.1640...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1640 Helium gas analyzer. (a) Identification. A helium gas analyzer is a device intended to measure the concentration of helium in a gas...

21 CFR 886.1360 - Visual field laser instrument.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Visual field laser instrument. 886.1360 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1360 Visual field laser instrument. (a) Identification. A visual field laser instrument is an AC-powered device intended to provide...

21 CFR 868.1700 - Nitrous oxide gas analyzer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Nitrous oxide gas analyzer. 868.1700 Section 868...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1700 Nitrous oxide gas analyzer. (a) Identification. A nitrous oxide gas analyzer is a device intended to measure the concentration of nitrous oxide...

21 CFR 892.1170 - Bone densitometer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Bone densitometer. 892.1170 Section 892.1170 Food... DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1170 Bone densitometer. (a) Identification. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or...

21 CFR 892.1170 - Bone densitometer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Bone densitometer. 892.1170 Section 892.1170 Food... DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1170 Bone densitometer. (a) Identification. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or...

21 CFR 892.1170 - Bone densitometer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Bone densitometer. 892.1170 Section 892.1170 Food... DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1170 Bone densitometer. (a) Identification. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or...

21 CFR 892.1170 - Bone densitometer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Bone densitometer. 892.1170 Section 892.1170 Food... DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1170 Bone densitometer. (a) Identification. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or...

21 CFR 892.1170 - Bone densitometer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Bone densitometer. 892.1170 Section 892.1170 Food... DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1170 Bone densitometer. (a) Identification. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or...

21 CFR 868.1975 - Water vapor analyzer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Water vapor analyzer. 868.1975 Section 868.1975...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1975 Water vapor analyzer. (a) Identification. A water vapor analyzer is a device intended to measure the concentration of water vapor in a...

21 CFR 868.1975 - Water vapor analyzer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Water vapor analyzer. 868.1975 Section 868.1975...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1975 Water vapor analyzer. (a) Identification. A water vapor analyzer is a device intended to measure the concentration of water vapor in a...

21 CFR 886.1510 - Eye movement monitor.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Eye movement monitor. 886.1510 Section 886.1510...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1510 Eye movement monitor. (a) Identification. An eye movement monitor is an AC-powered device with an electrode intended to measure and record...

21 CFR 886.1510 - Eye movement monitor.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Eye movement monitor. 886.1510 Section 886.1510...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1510 Eye movement monitor. (a) Identification. An eye movement monitor is an AC-powered device with an electrode intended to measure and record...

21 CFR 886.1410 - Ophthalmic trial lens clip.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic trial lens clip. 886.1410 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1410 Ophthalmic trial lens clip. (a) Identification. An ophthalmic trial lens clip is a device intended to hold prisms, spheres, cylinders, or...

21 CFR 886.1420 - Ophthalmic lens gauge.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic lens gauge. 886.1420 Section 886.1420...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1420 Ophthalmic lens gauge. (a) Identification. An ophthalmic lens gauge is a calibrated device intended to manually measure the curvature of a...

21 CFR 886.1425 - Lens measuring instrument.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Lens measuring instrument. 886.1425 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1425 Lens measuring instrument. (a) Identification. A lens measuring instrument is an AC-powered device intended to measure the power of lenses...

21 CFR 886.1170 - Color vision tester.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Color vision tester. 886.1170 Section 886.1170...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1170 Color vision tester. (a) Identification. A color vision tester is a device that consists of various colored materials, such as colored yarns...

21 CFR 886.1160 - Color vision plate illuminator.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Color vision plate illuminator. 886.1160 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1160 Color vision plate illuminator. (a) Identification. A color vision plate illuminator is an AC-powered device that is a lamp intended...

21 CFR 886.1160 - Color vision plate illuminator.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Color vision plate illuminator. 886.1160 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1160 Color vision plate illuminator. (a) Identification. A color vision plate illuminator is an AC-powered device that is a lamp intended...

21 CFR 886.1160 - Color vision plate illuminator.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Color vision plate illuminator. 886.1160 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1160 Color vision plate illuminator. (a) Identification. A color vision plate illuminator is an AC-powered device that is a lamp intended...

21 CFR 886.1170 - Color vision tester.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Color vision tester. 886.1170 Section 886.1170...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1170 Color vision tester. (a) Identification. A color vision tester is a device that consists of various colored materials, such as colored yarns...

21 CFR 886.1170 - Color vision tester.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Color vision tester. 886.1170 Section 886.1170...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1170 Color vision tester. (a) Identification. A color vision tester is a device that consists of various colored materials, such as colored yarns...

21 CFR 886.1655 - Ophthalmic Fresnel prism.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ophthalmic Fresnel prism. 886.1655 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1655 Ophthalmic Fresnel prism. (a) Identification. An ophthalmic Fresnel prism is a device that is a thin plastic sheet with embossed rulings which...

21 CFR 886.1655 - Ophthalmic Fresnel prism.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic Fresnel prism. 886.1655 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1655 Ophthalmic Fresnel prism. (a) Identification. An ophthalmic Fresnel prism is a device that is a thin plastic sheet with embossed rulings which...

21 CFR 886.1655 - Ophthalmic Fresnel prism.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic Fresnel prism. 886.1655 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1655 Ophthalmic Fresnel prism. (a) Identification. An ophthalmic Fresnel prism is a device that is a thin plastic sheet with embossed rulings which...

21 CFR 886.1655 - Ophthalmic Fresnel prism.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic Fresnel prism. 886.1655 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1655 Ophthalmic Fresnel prism. (a) Identification. An ophthalmic Fresnel prism is a device that is a thin plastic sheet with embossed rulings which...

21 CFR 886.1655 - Ophthalmic Fresnel prism.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic Fresnel prism. 886.1655 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1655 Ophthalmic Fresnel prism. (a) Identification. An ophthalmic Fresnel prism is a device that is a thin plastic sheet with embossed rulings which...

21 CFR 886.1880 - Fusion and stereoscopic target.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Fusion and stereoscopic target. 886.1880 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1880 Fusion and stereoscopic target. (a) Identification. A fusion and stereoscopic target is a device intended for use as a viewing object...

21 CFR 886.1880 - Fusion and stereoscopic target.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Fusion and stereoscopic target. 886.1880 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1880 Fusion and stereoscopic target. (a) Identification. A fusion and stereoscopic target is a device intended for use as a viewing object...

21 CFR 868.1400 - Carbon dioxide gas analyzer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Carbon dioxide gas analyzer. 868.1400 Section 868...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1400 Carbon dioxide gas analyzer. (a) Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide...

21 CFR 868.1400 - Carbon dioxide gas analyzer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Carbon dioxide gas analyzer. 868.1400 Section 868...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1400 Carbon dioxide gas analyzer. (a) Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide...

21 CFR 892.1860 - Radiographic film/cassette changer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Radiographic film/cassette changer. 892.1860... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1860 Radiographic film/cassette changer. (a) Identification. A radiographic film/cassette changer is a device intended to be used during a...

21 CFR 892.1840 - Radiographic film.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Radiographic film. 892.1840 Section 892.1840 Food... DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1840 Radiographic film. (a) Identification. Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both...

21 CFR 892.1840 - Radiographic film.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Radiographic film. 892.1840 Section 892.1840 Food... DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1840 Radiographic film. (a) Identification. Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both...

21 CFR 892.1860 - Radiographic film/cassette changer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Radiographic film/cassette changer. 892.1860... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1860 Radiographic film/cassette changer. (a) Identification. A radiographic film/cassette changer is a device intended to be used during a...

21 CFR 892.1640 - Radiographic film marking system.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Radiographic film marking system. 892.1640 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1640 Radiographic film marking system. (a) Identification. A radiographic film marking system is a device intended for medical purposes to...

21 CFR 892.1860 - Radiographic film/cassette changer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Radiographic film/cassette changer. 892.1860... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1860 Radiographic film/cassette changer. (a) Identification. A radiographic film/cassette changer is a device intended to be used during a...

21 CFR 892.1640 - Radiographic film marking system.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Radiographic film marking system. 892.1640 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1640 Radiographic film marking system. (a) Identification. A radiographic film marking system is a device intended for medical purposes to...

21 CFR 892.1840 - Radiographic film.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Radiographic film. 892.1840 Section 892.1840 Food... DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1840 Radiographic film. (a) Identification. Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both...

21 CFR 892.1640 - Radiographic film marking system.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Radiographic film marking system. 892.1640 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1640 Radiographic film marking system. (a) Identification. A radiographic film marking system is a device intended for medical purposes to...

21 CFR 892.1840 - Radiographic film.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Radiographic film. 892.1840 Section 892.1840 Food... DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1840 Radiographic film. (a) Identification. Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both...

21 CFR 892.1860 - Radiographic film/cassette changer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Radiographic film/cassette changer. 892.1860... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1860 Radiographic film/cassette changer. (a) Identification. A radiographic film/cassette changer is a device intended to be used during a...

21 CFR 892.1640 - Radiographic film marking system.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Radiographic film marking system. 892.1640 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1640 Radiographic film marking system. (a) Identification. A radiographic film marking system is a device intended for medical purposes to...

21 CFR 870.1100 - Blood pressure alarm.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Blood pressure alarm. 870.1100 Section 870.1100...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1100 Blood pressure alarm. (a) Identification. A blood pressure alarm is a device that accepts the signal from a blood pressure...

21 CFR 870.1140 - Venous blood pressure manometer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Venous blood pressure manometer. 870.1140 Section... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1140 Venous blood pressure manometer. (a) Identification. A venous blood pressure manometer is a device attached to a venous...

21 CFR 870.1140 - Venous blood pressure manometer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Venous blood pressure manometer. 870.1140 Section... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1140 Venous blood pressure manometer. (a) Identification. A venous blood pressure manometer is a device attached to a venous...

21 CFR 870.1120 - Blood pressure cuff.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Blood pressure cuff. 870.1120 Section 870.1120...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1120 Blood pressure cuff. (a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic...

21 CFR 870.1140 - Venous blood pressure manometer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Venous blood pressure manometer. 870.1140 Section... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1140 Venous blood pressure manometer. (a) Identification. A venous blood pressure manometer is a device attached to a venous...

21 CFR 870.1100 - Blood pressure alarm.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Blood pressure alarm. 870.1100 Section 870.1100...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1100 Blood pressure alarm. (a) Identification. A blood pressure alarm is a device that accepts the signal from a blood pressure...

21 CFR 870.1120 - Blood pressure cuff.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood pressure cuff. 870.1120 Section 870.1120...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1120 Blood pressure cuff. (a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic...

21 CFR 870.1120 - Blood pressure cuff.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Blood pressure cuff. 870.1120 Section 870.1120...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1120 Blood pressure cuff. (a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic...

21 CFR 870.1100 - Blood pressure alarm.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Blood pressure alarm. 870.1100 Section 870.1100...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1100 Blood pressure alarm. (a) Identification. A blood pressure alarm is a device that accepts the signal from a blood pressure...

21 CFR 870.1120 - Blood pressure cuff.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Blood pressure cuff. 870.1120 Section 870.1120...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1120 Blood pressure cuff. (a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic...

21 CFR 870.1140 - Venous blood pressure manometer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Venous blood pressure manometer. 870.1140 Section... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1140 Venous blood pressure manometer. (a) Identification. A venous blood pressure manometer is a device attached to a venous...

21 CFR 870.1100 - Blood pressure alarm.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood pressure alarm. 870.1100 Section 870.1100...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1100 Blood pressure alarm. (a) Identification. A blood pressure alarm is a device that accepts the signal from a blood pressure...

21 CFR 868.1690 - Nitrogen gas analyzer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nitrogen gas analyzer. 868.1690 Section 868.1690...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1690 Nitrogen gas analyzer. (a) Identification. A nitrogen gas analyzer is a device intended to measure the concentration of nitrogen in...

21 CFR 868.1690 - Nitrogen gas analyzer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Nitrogen gas analyzer. 868.1690 Section 868.1690...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1690 Nitrogen gas analyzer. (a) Identification. A nitrogen gas analyzer is a device intended to measure the concentration of nitrogen in...

21 CFR 868.1690 - Nitrogen gas analyzer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Nitrogen gas analyzer. 868.1690 Section 868.1690...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1690 Nitrogen gas analyzer. (a) Identification. A nitrogen gas analyzer is a device intended to measure the concentration of nitrogen in...

21 CFR 886.1415 - Ophthalmic trial lens frame.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic trial lens frame. 886.1415 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1415 Ophthalmic trial lens frame. (a) Identification. An opthalmic trial lens frame is a mechanical device intended to hold trial lenses for vision...

21 CFR 866.1 - Scope.

Code of Federal Regulations, 2014 CFR

2014-04-01

... MICROBIOLOGY DEVICES General Provisions § 866.1 Scope. (a) This part sets forth the classification of immunology and microbiology devices intended for human use that are in commercial distribution. (b) The... immunology and microbiology device that has two or more types of uses (e.g., used both as a diagnostic device...

21 CFR 866.1 - Scope.

Code of Federal Regulations, 2012 CFR

2012-04-01

... MICROBIOLOGY DEVICES General Provisions § 866.1 Scope. (a) This part sets forth the classification of immunology and microbiology devices intended for human use that are in commercial distribution. (b) The... immunology and microbiology device that has two or more types of uses (e.g., used both as a diagnostic device...

21 CFR 866.1 - Scope.

Code of Federal Regulations, 2011 CFR

2011-04-01

... MICROBIOLOGY DEVICES General Provisions § 866.1 Scope. (a) This part sets forth the classification of immunology and microbiology devices intended for human use that are in commercial distribution. (b) The... immunology and microbiology device that has two or more types of uses (e.g., used both as a diagnostic device...

21 CFR 866.1 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... MICROBIOLOGY DEVICES General Provisions § 866.1 Scope. (a) This part sets forth the classification of immunology and microbiology devices intended for human use that are in commercial distribution. (b) The... immunology and microbiology device that has two or more types of uses (e.g., used both as a diagnostic device...

21 CFR 866.1 - Scope.

Code of Federal Regulations, 2013 CFR

2013-04-01

... MICROBIOLOGY DEVICES General Provisions § 866.1 Scope. (a) This part sets forth the classification of immunology and microbiology devices intended for human use that are in commercial distribution. (b) The... immunology and microbiology device that has two or more types of uses (e.g., used both as a diagnostic device...

21 CFR 892.1640 - Radiographic film marking system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Radiographic film marking system. 892.1640 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1640 Radiographic film marking system. (a) Identification. A radiographic film marking system is a device intended for medical purposes to...

21 CFR 892.1860 - Radiographic film/cassette changer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Radiographic film/cassette changer. 892.1860... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1860 Radiographic film/cassette changer. (a) Identification. A radiographic film/cassette changer is a device intended to be used during a...

21 CFR 892.1840 - Radiographic film.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Radiographic film. 892.1840 Section 892.1840 Food... DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1840 Radiographic film. (a) Identification. Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both...

21 CFR 886.1670 - Ophthalmic isotope uptake probe.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic isotope uptake probe. 886.1670 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1670 Ophthalmic isotope uptake probe. (a) Identification. An ophthalmic isotope uptake probe is an AC-powered device intended to measure...

21 CFR 886.1670 - Ophthalmic isotope uptake probe.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic isotope uptake probe. 886.1670 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1670 Ophthalmic isotope uptake probe. (a) Identification. An ophthalmic isotope uptake probe is an AC-powered device intended to measure...

21 CFR 886.1670 - Ophthalmic isotope uptake probe.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic isotope uptake probe. 886.1670 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1670 Ophthalmic isotope uptake probe. (a) Identification. An ophthalmic isotope uptake probe is an AC-powered device intended to measure...

21 CFR 868.1975 - Water vapor analyzer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Water vapor analyzer. 868.1975 Section 868.1975...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1975 Water vapor analyzer. (a) Identification. A water vapor analyzer is a device intended to measure the concentration of water vapor in a...

21 CFR 886.1160 - Color vision plate illuminator.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Color vision plate illuminator. 886.1160 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1160 Color vision plate illuminator. (a) Identification. A color vision plate illuminator is an AC-powered device that is a lamp intended...

21 CFR 886.1160 - Color vision plate illuminator.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Color vision plate illuminator. 886.1160 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1160 Color vision plate illuminator. (a) Identification. A color vision plate illuminator is an AC-powered device that is a lamp intended...

21 CFR 886.1170 - Color vision tester.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Color vision tester. 886.1170 Section 886.1170...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1170 Color vision tester. (a) Identification. A color vision tester is a device that consists of various colored materials, such as colored yarns...

21 CFR 886.1170 - Color vision tester.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Color vision tester. 886.1170 Section 886.1170...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1170 Color vision tester. (a) Identification. A color vision tester is a device that consists of various colored materials, such as colored yarns...

21 CFR 868.1720 - Oxygen gas analyzer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Oxygen gas analyzer. 868.1720 Section 868.1720...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1720 Oxygen gas analyzer. (a) Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory...

21 CFR 868.1730 - Oxygen uptake computer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Oxygen uptake computer. 868.1730 Section 868.1730...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1730 Oxygen uptake computer. (a) Identification. An oxygen uptake computer is a device intended to compute the amount of oxygen consumed by a...

21 CFR 868.1730 - Oxygen uptake computer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Oxygen uptake computer. 868.1730 Section 868.1730...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1730 Oxygen uptake computer. (a) Identification. An oxygen uptake computer is a device intended to compute the amount of oxygen consumed by a...

21 CFR 868.1720 - Oxygen gas analyzer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Oxygen gas analyzer. 868.1720 Section 868.1720...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1720 Oxygen gas analyzer. (a) Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory...

21 CFR 868.1720 - Oxygen gas analyzer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Oxygen gas analyzer. 868.1720 Section 868.1720...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1720 Oxygen gas analyzer. (a) Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory...

21 CFR 868.1730 - Oxygen uptake computer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Oxygen uptake computer. 868.1730 Section 868.1730...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1730 Oxygen uptake computer. (a) Identification. An oxygen uptake computer is a device intended to compute the amount of oxygen consumed by a...

21 CFR 868.1730 - Oxygen uptake computer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Oxygen uptake computer. 868.1730 Section 868.1730...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1730 Oxygen uptake computer. (a) Identification. An oxygen uptake computer is a device intended to compute the amount of oxygen consumed by a...

21 CFR 868.1720 - Oxygen gas analyzer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Oxygen gas analyzer. 868.1720 Section 868.1720...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1720 Oxygen gas analyzer. (a) Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory...

21 CFR 868.1730 - Oxygen uptake computer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Oxygen uptake computer. 868.1730 Section 868.1730...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1730 Oxygen uptake computer. (a) Identification. An oxygen uptake computer is a device intended to compute the amount of oxygen consumed by a...

21 CFR 868.1720 - Oxygen gas analyzer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Oxygen gas analyzer. 868.1720 Section 868.1720...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1720 Oxygen gas analyzer. (a) Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory...

21 CFR 868.1975 - Water vapor analyzer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Water vapor analyzer. 868.1975 Section 868.1975...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1975 Water vapor analyzer. (a) Identification. A water vapor analyzer is a device intended to measure the concentration of water vapor in a...

21 CFR 868.1975 - Water vapor analyzer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Water vapor analyzer. 868.1975 Section 868.1975...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1975 Water vapor analyzer. (a) Identification. A water vapor analyzer is a device intended to measure the concentration of water vapor in a...

21 CFR 874.1820 - Surgical nerve stimulator/locator.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Surgical nerve stimulator/locator. 874.1820... (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Diagnostic Devices § 874.1820 Surgical nerve stimulator/locator. (a) Identification. A surgical nerve stimulator/locator is a device that is intended to...

21 CFR 886.1360 - Visual field laser instrument.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Visual field laser instrument. 886.1360 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1360 Visual field laser instrument. (a) Identification. A visual field laser instrument is an AC-powered device intended to provide...

21 CFR 886.1360 - Visual field laser instrument.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Visual field laser instrument. 886.1360 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1360 Visual field laser instrument. (a) Identification. A visual field laser instrument is an AC-powered device intended to provide...

21 CFR 886.1360 - Visual field laser instrument.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Visual field laser instrument. 886.1360 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1360 Visual field laser instrument. (a) Identification. A visual field laser instrument is an AC-powered device intended to provide...

21 CFR 886.1140 - Ophthalmic chair.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic chair. 886.1140 Section 886.1140 Food... DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1140 Ophthalmic chair. (a) Identification. An ophthalmic chair is an AC-powered or manual device with adjustable positioning in which a patient is to sit...

21 CFR 886.1750 - Skiascopic rack.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Skiascopic rack. 886.1750 Section 886.1750 Food... DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1750 Skiascopic rack. (a) Identification. A skiascopic rack is a device that is a rack and a set of attached ophthalmic lenses of various dioptric strengths...

21 CFR 892.1320 - Nuclear uptake probe.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Nuclear uptake probe. 892.1320 Section 892.1320...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1320 Nuclear uptake probe. (a) Identification. A nuclear uptake probe is a device intended to measure the amount of radionuclide taken up by a...

21 CFR 892.1330 - Nuclear whole body scanner.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nuclear whole body scanner. 892.1330 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1330 Nuclear whole body scanner. (a) Identification. A nuclear whole body scanner is a device intended to measure and image the distribution of...

21 CFR 892.1320 - Nuclear uptake probe.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nuclear uptake probe. 892.1320 Section 892.1320...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1320 Nuclear uptake probe. (a) Identification. A nuclear uptake probe is a device intended to measure the amount of radionuclide taken up by a...

21 CFR 892.1330 - Nuclear whole body scanner.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Nuclear whole body scanner. 892.1330 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1330 Nuclear whole body scanner. (a) Identification. A nuclear whole body scanner is a device intended to measure and image the distribution of...

21 CFR 892.2030 - Medical image digitizer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical image digitizer. 892.2030 Section 892.2030...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2030 Medical image digitizer. (a) Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital...

21 CFR 892.2030 - Medical image digitizer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical image digitizer. 892.2030 Section 892.2030...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2030 Medical image digitizer. (a) Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital...

21 CFR 892.2030 - Medical image digitizer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image digitizer. 892.2030 Section 892.2030...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2030 Medical image digitizer. (a) Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital...

21 CFR 892.2030 - Medical image digitizer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical image digitizer. 892.2030 Section 892.2030...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2030 Medical image digitizer. (a) Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital...

21 CFR 892.1630 - Electrostatic x-ray imaging system.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Electrostatic x-ray imaging system. 892.1630... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1630 Electrostatic x-ray imaging system. (a) Identification. An electrostatic x-ray imaging system is a device intended for medical...

21 CFR 892.1630 - Electrostatic x-ray imaging system.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Electrostatic x-ray imaging system. 892.1630... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1630 Electrostatic x-ray imaging system. (a) Identification. An electrostatic x-ray imaging system is a device intended for medical...

Endoscopic full-thickness resection in the colorectum with a novel over-the-scope device: first experience.

PubMed

Schmidt, Arthur; Bauerfeind, Peter; Gubler, Christoph; Damm, Michael; Bauder, Markus; Caca, Karel

2015-08-01

Endoscopic full-thickness resection (EFTR) in the lower gastrointestinal tract may be a valuable therapeutic and diagnostic approach for a variety of indications. Although feasibility of EFTR has been demonstrated, there is a lack of safe and effective endoscopic devices for routine use. The aim of this study was to investigate the efficacy and safety of a novel over-the-scope device for colorectal EFTR. Between July 2012 and July 2014, 25 patients underwent EFTR at two tertiary referral centers. All resections were performed using the full-thickness resection device (FTRD; Ovesco Endoscopy, Tübingen, Germany). Data were collected retrospectively. Indications for EFTR were: recurrent or incompletely resected adenoma with nonlifting sign (n = 11), untreated adenoma and nonlifting sign (n = 2), adenoma involving the appendix (n = 5), flat adenoma in a patient with coagulopathy (n = 1), diagnostic re-resection after incomplete resection of a T1 carcinoma (n = 2), adenoma involving a diverticulum (n = 1), submucosal tumor (n = 2), and diagnostic resection in a patient with suspected Hirschsprung's disease (n = 1). In one patient, the lesion could not be reached because of a sigmoid stenosis. In the other patients, resection of the lesion was macroscopically complete and en bloc in 20/24 patients (83.3 %). The mean diameter of the resection specimen was 24 mm (range 12 - 40 mm). The R0 resection rate was 75.0 % (18/24), and full-thickness resection was histologically confirmed in 87.5 %. No perforations or major bleeding were observed during or after resection. Two patients developed postpolypectomy syndrome, which was managed with antibiotic therapy. Full-thickness resection in the lower gastrointestinal tract with the novel FTRD was feasible and effective. Prospective studies are needed to further evaluate the device and technique. © Georg Thieme Verlag KG Stuttgart · New York.

Fundamental Studies of the Electrode Regions in Arcjet Thrusters

DTIC Science & Technology

1998-03-01

Hall thruster . This contributed to a comprehensive study of the near exit region of our Hall discharge device. To compliment the LIF diagnostics on our Hall thrusters, we have made extensive measurements of the transient and time average plasma properties using conventional electrostatic

Diagnostic performance of an automatic blood pressure measurement device, Microlife WatchBP Home A, for atrial fibrillation screening in a real-world primary care setting.

PubMed

Chan, Pak-Hei; Wong, Chun-Ka; Pun, Louise; Wong, Yu-Fai; Wong, Michelle Man-Ying; Chu, Daniel Wai-Sing; Siu, Chung-Wah

2017-06-15

To evaluate the diagnostic performance of a UK National Institute for Health and Care Excellence-recommended automatic oscillometric blood pressure (BP) measurement device incorporated with an atrial fibrillation (AF) detection algorithm (Microlife WatchBP Home A) for real-world AF screening in a primary healthcare setting. Primary healthcare setting in Hong Kong. This was a prospective AF screening study carried out between 1 September 2014 and 14 January 2015. The Microlife device was evaluated for AF detection and compared with a reference standard of lead-I ECG. Diagnostic performance of Microlife for AF detection. 5969 patients (mean age: 67.2±11.0 years; 53.9% female) were recruited. The mean CHA 2 DS 2 -VASc ( C : congestive heart failure [1 point]; H : hypertension [1 point]; A 2 : age 65-74 years [1 point] and age ≥75 years [2 points]; D : diabetes mellitus [1 point]; S : prior stroke or transient ischemic attack [2 points]; VA : vascular disease [1 point]; and Sc : sex category [female] [1 point])score was 2.8±1.3. AF was diagnosed in 72 patients (1.21%) and confirmed by a 12-lead ECG. The Microlife device correctly identified AF in 58 patients and produced 79 false-positives. The corresponding sensitivity and specificity for AF detection were 80.6% (95% CI 69.5 to 88.9) and 98.7% (95% CI 98.3 to 98.9), respectively. Among patients with a false-positive by the Microlife device, 30.4% had sinus rhythm, 35.4% had sinus arrhythmia and 29.1% exhibited premature atrial complexes. With the low prevalence of AF in this population, the positive and negative predictive values of Microlife device for AF detection were 42.4% (95% CI 34.0 to 51.2) and 99.8% (95% CI 99.6 to 99.9), respectively. The overall diagnostic performance of Microlife device to detect AF as determined by area under the curves was 0.90 (95% CI 0.89 to 0.90). In the primary care setting, Microlife WatchBP Home was an effective means to screen for AF, with a reasonable sensitivity of 80.6% and a high negative predictive value of 99.8%, in addition to its routine function of BP measurement. In a younger patient population aged <65 years with a lower prevalence of AF, Microlife WatchBP Home A demonstrated a similar diagnostic accuracy. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Assessment of radiological protection systems among diagnostic radiology facilities in North East India.

PubMed

Singh, Thokchom Dewan; Jayaraman, T; Arunkumar Sharma, B

2017-03-01

This study aims to assess the adequacy level of radiological protection systems available in the diagnostic radiology facilities located in three capital cities of North East (NE) India. It further attempts to understand, using a multi-disciplinary approach, how the safety codes/standards in diagnostic radiology framed by the Atomic Energy Regulatory Board (AERB) and the International Atomic Energy Agency (IAEA) to achieve adequate radiological protection in facilities, have been perceived, conceptualized, and applied accordingly in these facilities. About 30 diagnostic radiology facilities were randomly selected from three capitals of states in NE India; namely Imphal (Manipur), Shillong (Meghalaya) and Guwahati (Assam). A semi-structured questionnaire developed based on a multi-disciplinary approach was used for this study. It was observed that radiological practices undertaken in these facilities were not exactly in line with safety codes/standards in diagnostic radiology of the AERB and the IAEA. About 50% of the facilities had registered/licensed x-ray equipment with the AERB. More than 80% of the workers did not use radiation protective devices, although these devices were available in the facilities. About 85% of facilities had no institutional risk management system. About 70% of the facilities did not carry out periodic quality assurance testing of their x-ray equipment or surveys of radiation leakage around the x-ray room, and did not display radiation safety indicators in the x-ray rooms. Workers in these facilities exhibited low risk perception about the risks associated with these practices. The majority of diagnostic radiology facilities in NE India did not comply with the radiological safety codes/standards framed by the AERB and IAEA. The study found inadequate levels of radiological protection systems in the majority of facilities. This study suggests a need to establish firm measures that comply with the radiological safety codes/standards of the AERB and IAEA to protect patients, workers and the public of this region.

21 CFR 864.9275 - Blood bank centrifuge for in vitro diagnostic use.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood bank centrifuge for in vitro diagnostic use... Manufacture Blood and Blood Products § 864.9275 Blood bank centrifuge for in vitro diagnostic use. (a) Identification. A blood bank centrifuge for in vitro diagnostic use is a device used only to separate blood cells...

21 CFR 864.9275 - Blood bank centrifuge for in vitro diagnostic use.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Blood bank centrifuge for in vitro diagnostic use... Manufacture Blood and Blood Products § 864.9275 Blood bank centrifuge for in vitro diagnostic use. (a) Identification. A blood bank centrifuge for in vitro diagnostic use is a device used only to separate blood cells...

21 CFR 864.9275 - Blood bank centrifuge for in vitro diagnostic use.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Blood bank centrifuge for in vitro diagnostic use... Manufacture Blood and Blood Products § 864.9275 Blood bank centrifuge for in vitro diagnostic use. (a) Identification. A blood bank centrifuge for in vitro diagnostic use is a device used only to separate blood cells...

21 CFR 864.9275 - Blood bank centrifuge for in vitro diagnostic use.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Blood bank centrifuge for in vitro diagnostic use... Manufacture Blood and Blood Products § 864.9275 Blood bank centrifuge for in vitro diagnostic use. (a) Identification. A blood bank centrifuge for in vitro diagnostic use is a device used only to separate blood cells...

Ultrasound microscope: the new field in ultrasound diagnostics

NASA Astrophysics Data System (ADS)

Novyc'kyy, Victor V.; Lushchyk, Ulyana B.

2001-06-01

A device which is a new stage in the development of medical equipment has been developed. The device works as an ultrasound microscope in vivo and provides 4 up to 32 colored histological image. It gives possibility to estimate tissue acoustic density with the help of 4 up to 32 gradation coloring different tissues and enables tissue microcirculation visualization. With the help of the device a doctor can objectify fatty hepatitis and cirrhosis, edema of different organs and tissues as well as microcirculation in organs and tissues (e.g. muscles, myocard and bone system). New promising applications of ultrasound systems in diagnostics and for choosing individual treatment tactics, with pathogenesis being taken into account, may be developed with the help of the device.

Rooftop package unit diagnostician

DOEpatents

Chassin, David P [Pasco, WA; Pratt, Robert G [Kennewick, WA; Reid, Larry Dean [Benton City, WA

2004-08-17

A diagnostic system for an HVAC system includes a number of sensors used to measure the operation of the HVAC system. Sensor readings are measured by timing the delay between when a strobe signal is sent to a sensor and when an interrupt signal from the sensor is received. A device driver used to measure the sensor readings stores the sensor readings in pseudo-character device files, which are universally accessible by different subsystems of the diagnostic system. Based on the readings from these sensors, this diagnostic system is able to determine the operational status of the HVAC system and if an economizer in the HVAC system is operating properly.

Implanted medical devices in the radiation environment of commercial spaceflight.

PubMed

Reyes, David P; McClure, Steven S; Chancellor, Jeffery C; Blue, Rebecca S; Castleberry, Tarah L; Vanderploeg, James M

2014-11-01

Some commercial spaceflight participants (SFPs) may have medical conditions that require implanted medical devices (IMDs), such as cardiac pacemakers, defibrillators, insulin pumps, or similar electronic devices. The effect of space radiation on the function of IMDs is unknown. This review will identify known effects of terrestrial and aviation electromagnetic interference (EMI) and radiation on IMDs in order to provide insight into the potential effects of radiation exposures in the space environment. A systematic literature review was conducted on available literature on human studies involving the effects of EMI as well as diagnostic and therapeutic radiation on IMDs. The literature review identified potential transient effects from EMI and diagnostic radiation levels as low as 10 mGy on IMDs. High-energy, therapeutic, ionizing radiation can cause more permanent device malfunctions at doses as low as 40 mGy. Radiation doses from suborbital flight altitudes and durations are anticipated to be less than those experienced during an average round-trip, cross-country airline flight and are unlikely to result in significant detriment, though longer, orbital flights may expose SFPs to doses potentially harmful to IMD function. Individuals with IMDs should experience few, if any, radiation-related device malfunctions during suborbital flight, but could have problems with radiation exposures associated with longer, orbital flights.

LABEL-FREE VIRUS CAPTURE AND RELEASE BY A MICROFLUIDIC DEVICE INTEGRATED WITH POROUS SILICON NANOWIRE FOREST

PubMed Central

Xia, Yiqiu; Tang, Yi; Yu, Xu; Wan, Yuan; Chen, Yizhu; Lu, Huaguang; Zheng, Si-Yang

2016-01-01

Viral diseases are perpetual threats to human and animal health. Detection and characterization of viral pathogens require accurate, sensitive and rapid diagnostic assays. For field and clinical samples, the sample preparation procedures limit the ultimate performance and utility of the overall virus diagnostic protocols. Here, we presented the development of a microfluidic device embedded with porous silicon nanowire (pSiNW) forest for label-free size-based point-of-care virus capture in a continuous curved flow design. The pSiNW forests with specific inter-wire spacing were synthesized in situ on both bottom and sidewalls of the microchannels in a batch process. With the enhancement effect of Dean flow, we demonstrated ~50% H5N2 avian influenza viruses were physically trapped without device clogging. A unique feature of the device is that captured viruses can be released by inducing self-degradation of the pSiNWs in physiological aqueous environment. About 60% of captured viruses can be released within 24 hours for virus culture, subsequent molecular diagnosis and other virus characterization and analyses. This device performs viable, unbiased and label-free virus isolation and release. It has great potentials for virus discovery, virus isolation and culture, functional studies of virus pathogenicity, transmission, drug screening, and vaccine development. PMID:27918640

Draw your assay: Fabrication of low-cost paper-based diagnostic and multi-well test zones by drawing on a paper.

PubMed

Oyola-Reynoso, Stephanie; Heim, Andrew P; Halbertsma-Black, Julian; Zhao, C; Tevis, Ian D; Çınar, Simge; Cademartiri, Rebecca; Liu, Xinyu; Bloch, Jean-Francis; Thuo, Martin M

2015-11-01

Interest in low-cost diagnostic devices has recently gained attention, in part due to the rising cost of healthcare and the need to serve populations in resource-limited settings. A major challenge in the development of such devices is the need for hydrophobic barriers to contain polar bio-fluid analytes. Key approaches in lowering the cost in diagnostics have centered on (i) development of low-cost fabrication techniques/processes, (ii) use of affordable materials, or, (iii) minimizing the need for high-tech tools. This communication describes a simple, low-cost, adaptable, and portable method for patterning paper and subsequent use of the patterned paper in diagnostic tests. Our approach generates hydrophobic regions using a ball-point pen filled with a hydrophobizing molecule suspended in a solvent carrier. An empty ball-point pen was filled with a solution of trichloro perfluoroalkyl silane in hexanes (or hexadecane), and the pen used to draw lines on Whatman® chromatography 1 paper. The drawn regions defined the test zones since the trichloro silane reacts with the paper to give a hydrophobic barrier. The formation of the hydrophobic barriers is reaction kinetic and diffusion-limited, ensuring well defined narrow barriers. We performed colorimetric glucose assays and enzyme-linked immuno-sorbent assay (ELISA) using the created test zones. To demonstrate the versatility of this approach, we fabricated multiple devices on a single piece of paper and demonstrated the reproducibility of assays on these devices. The overall cost of devices fabricated by drawing are relatively lower (

[The validation of the parameters for a basic model of a power supply layout for general x-ray diagnostic apparatus].

PubMed

Blinov, N N

2000-01-01

Specifications for the main element of a modern X-ray diagnostic device an X-ray feeder are formulated. There is evidence for choosing its parameters. The new rational routine of X-ray study and the layout of a X-ray room are proposed. Information on the up-to-date commercially manufactured basic medium-frequency general-purpose X-ray feeder "URP-30 SCh Amico" is given.

Integrated Diagnostic and Treatment Devices for Enroute Critical Care of Patients within Theater

DTIC Science & Technology

2010-04-01

are all indicated for both adult and pediatric patients, are lightweight systems designed to attach either directly to a NATO litter or attach to a...external defibrillator and blood chemistry analysis system. Figure 1: Patient Being Transported with the Life Support for Trauma and Transport...be difficult to replace or refill. The LSTAT was also designed to accept external oxygen sources. Integrated Diagnostic and Treatment Devices for

Scanning and Measuring Device for Diagnostic of Barrel Bore

NASA Astrophysics Data System (ADS)

Marvan, Ales; Hajek, Josef; Vana, Jan; Dvorak, Radim; Drahansky, Martin; Jankovych, Robert; Skvarek, Jozef

The article discusses the design, mechanical design, electronics and software for robot diagnosis of barrels with caliber of 120 mm to 155 mm. This diagnostic device is intended primarily for experimental research and verification of appropriate methods and technologies for the diagnosis of the main bore guns. Article also discusses the design of sensors and software, the issue of data processing and image reconstruction obtained by scanning of the surface of the bore.

Bioelectronic Sensors and Devices

NASA Astrophysics Data System (ADS)

Reed, Mark

Nanoscale electronic devices have recently enabled the ability to controllably probe biological systems, from the molecular to the cellular level, opening up new applications and understanding of biological function and response. This talk reviews some of the advances in the field, ranging from diagnostic and therapeutic applications, to cellular manipulation and response, to the emulation of biological response. In diagnostics, integrated nanodevice biosensors compatible with CMOS technology have achieved unprecedented sensitivity, enabling a wide range of label-free biochemical and macromolecule sensing applications down to femtomolar concentrations. These systems have demonstrated integrated assays of biomarkers at clinically important concentrations for both diagnostics and as a quantitative tool for drug design and discovery. Cellular level response can also be observed, including immune response function and dynamics. Finally, the field is beginning to create devices that emulate function, and the demonstration of a solid state artificial ion channel will be discussed.

IFSA: a microfluidic chip-platform for frit-based immunoassay protocols

NASA Astrophysics Data System (ADS)

Hlawatsch, Nadine; Bangert, Michael; Miethe, Peter; Becker, Holger; Gärtner, Claudia

2013-03-01

Point-of-care diagnostics (POC) is one of the key application fields for lab-on-a-chip devices. While in recent years much of the work has concentrated on integrating complex molecular diagnostic assays onto a microfluidic device, there is a need to also put comparatively simple immunoassay-type protocols on a microfluidic platform. In this paper, we present the development of a microfluidic cartridge using an immunofiltration approach. In this method, the sandwich immunoassay takes place in a porous frit on which the antibodies have immobilized. The device is designed to be able to handle three samples in parallel and up to four analytical targets per sample. In order to meet the critical cost targets for the diagnostic market, the microfluidic chip has been designed and manufactured using high-volume manufacturing technologies in mind. Validation experiments show comparable sensitivities in comparison with conventional immunofiltration kits.

21 CFR 882.1240 - Echoencephalograph.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Echoencephalograph. 882.1240 Section 882.1240 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1240 Echoencephalograph. (a...

21 CFR 882.1400 - Electroencephalograph.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Electroencephalograph. 882.1400 Section 882.1400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1400 Electroencephalograph. (a...

21 CFR 882.1240 - Echoencephalograph.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Echoencephalograph. 882.1240 Section 882.1240 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1240 Echoencephalograph. (a...

21 CFR 882.1400 - Electroencephalograph.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Electroencephalograph. 882.1400 Section 882.1400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1400 Electroencephalograph. (a...

21 CFR 882.1825 - Rheoencephalograph.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Rheoencephalograph. 882.1825 Section 882.1825 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1825 Rheoencephalograph. (a...

21 CFR 882.1825 - Rheoencephalograph.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Rheoencephalograph. 882.1825 Section 882.1825 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1825 Rheoencephalograph. (a...

21 CFR 868.1760 - Volume plethysmograph.

Code of Federal Regulations, 2011 CFR

2011-04-01

... the patient's lung volume changes. (b) Classification. Class II (performance standards). ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Volume plethysmograph. 868.1760 Section 868.1760...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1760 Volume plethysmograph. (a...

Control and Diagnostic Model of Brushless Dc Motor

NASA Astrophysics Data System (ADS)

Abramov, Ivan V.; Nikitin, Yury R.; Abramov, Andrei I.; Sosnovich, Ella V.; Božek, Pavol

2014-09-01

A simulation model of brushless DC motor (BLDC) control and diagnostics is considered. The model has been developed using a freeware complex "Modeling in technical devices". Faults and diagnostic parameters of BLDC are analyzed. A logicallinguistic diagnostic model of BLDC has been developed on basis of fuzzy logic. The calculated rules determine dependence of technical condition on diagnostic parameters, their trends and utilized lifetime of BLDC. Experimental results of BLDC technical condition diagnostics are discussed. It is shown that in the course of BLDC degradation the motor condition change depends on diagnostic parameter values

77 FR 2071 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-13

.... Docket No. Applicant Trade name Approval date P100031, FDA-2011-M-0502...... Roche Diagnostics ELECSYS......... Roche Diagnostics ELECSYS ANTI-HBC IMMUNOASSAY, June 27, 2011. Corp.. ELECSYS PRECICONTROL ANTI-HBC FOR... IMMUNODIAGNOSTICS July 20, 2011. Diagnostics, PRODUCTS ANTI-HBE REAGENT PACK, Inc.. VITROS IMMUNODIAGNOSTIC PRODUCTS...

Head-Impact–Measurement Devices: A Systematic Review

PubMed Central

O'Connor, Kathryn L.; Rowson, Steven; Duma, Stefan M.; Broglio, Steven P.

2017-01-01

Context: With an estimated 3.8 million sport- and recreation-related concussions occurring annually, targeted prevention and diagnostic methods are needed. Biomechanical analysis of head impacts may provide quantitative information that can inform both prevention and diagnostic strategies. Objective: To assess available head-impact devices and their clinical utility. Data Sources: We performed a systematic search of the electronic database PubMed for peer-reviewed publications, using the following phrases: accelerometer and concussion, head impact telemetry, head impacts and concussion and sensor, head impacts and sensor, impact sensor and concussion, linear acceleration and concussion, rotational acceleration and concussion, and xpatch concussion. In addition to the literature review, a Google search for head impact monitor and concussion monitor yielded 15 more devices. Study Selection: Included studies were performed in vivo, used commercially available devices, and focused on sport-related concussion. Data Extraction: One author reviewed the title and abstract of each study for inclusion and exclusion criteria and then reviewed each full-text article to confirm inclusion criteria. Controversial articles were reviewed by all authors to reach consensus. Data Synthesis: In total, 61 peer-reviewed articles involving 4 head-impact devices were included. Participants in boxing, football, ice hockey, soccer, or snow sports ranged in age from 6 to 24 years; 18% (n = 11) of the studies included female athletes. The Head Impact Telemetry System was the most widely used device (n = 53). Fourteen additional commercially available devices were presented. Conclusions: Measurements collected by impact monitors provided real-time data to estimate player exposure but did not have the requisite sensitivity to concussion. Proper interpretation of previously reported head-impact kinematics across age, sport, and position may inform future research and enable staff clinicians working on the sidelines to monitor athletes. However, head-impact–monitoring systems have limited clinical utility due to error rates, designs, and low specificity in predicting concussive injury. PMID:28387553

Implantable loop recorders for assessment of syncope: increased diagnostic yield and less adverse outcomes with the latest generation devices.

PubMed

Bartoletti, A; Bocconcelli, P; De Santo, T; Ghidini Ottonelli, A; Giuli, S; Massa, R; Svetlich, C; Tarsi, G; Corbucci, G; Tronconi, F; Vitale, E

2013-08-01

Aim of the study was to compare the diagnostic yield of implantable loop recorders (ILR) of two successive generations for the assessment of syncope. Data on patients who had undergone ILR implantation for unexplained syncope in four Italian public hospitals were retrospectively acquired from the Medtronic Clinical Service database. After implantation, routine follow-up examinations were performed every 90 days, while urgent examinations were carried out in the event of syncope recurrence. The following findings were regarded as diagnostic: ECG documentation of a syncope recurrence; documentation of any of the arrhythmias listed by the current guidelines as diagnostic findings even if asymptomatic. Between November 2002 and March 2010, 107 patients received an ILR (40 Medtronic Reveal® Plus; 67 Medtronic Reveal® DX/XT) and underwent at least one follow-up examination. Diagnoses were made in 7 (17.5%) and 24 (35.8%) (P=0.043) patients, with a median time of 228 and 65 days, respectively. Three (42.9%) and 21 (87.5%) (P=0.029) diagnoses were based on automatically detected events, while adverse outcomes occurred in 6 and in 1 (P=0.01) patients, respectively. Our results show that the new-generation device offer a higher diagnostic yield, mainly as a result of its improved automatic detection function, and is associated with fewer adverse outcomes.

GryphSens: A Smartphone-Based Portable Diagnostic Reader for the Rapid Detection of Progesterone in Milk

PubMed Central

Jang, Hyunwook; Ahmed, Syed Rahin; Neethirajan, Suresh

2017-01-01

Enzyme-linked immunosorbent assay (ELISA) is a popular assay technique for the detection and quantification of various biological substances due its high sensitivity and specificity. More often, it requires large and expensive laboratory instruments, which makes it difficult to conduct when the tests must be performed quickly at the point-of-care (POC). To increase portability and ease of use, we propose a portable diagnostic system based on a Raspberry Pi imaging sensor for the rapid detection of progesterone in milk samples. We designed, assembled, and tested a standalone portable diagnostic reader and validated it for progesterone detection against a standard ELISA assay using a commercial plate reader. The portable POC device yielded consistent results, regardless of differences in the cameras and flashlights between various smartphone devices. An Android application was built to provide front-end access to users, control the diagnostic reader, and display and store the progesterone measurement on the smartphone. The diagnostic reader takes images of the samples, reads the pixel values, processes the results, and presents the results on the handheld device. The proposed POC reader can perform to superior levels of performance as a plate reader, while adding the desirable qualities of portability and ease of use. PMID:28489036

GryphSens: A Smartphone-Based Portable Diagnostic Reader for the Rapid Detection of Progesterone in Milk.

PubMed

Jang, Hyunwook; Ahmed, Syed Rahin; Neethirajan, Suresh

2017-05-10

Enzyme-linked immunosorbent assay (ELISA) is a popular assay technique for the detection and quantification of various biological substances due its high sensitivity and specificity. More often, it requires large and expensive laboratory instruments, which makes it difficult to conduct when the tests must be performed quickly at the point-of-care (POC). To increase portability and ease of use, we propose a portable diagnostic system based on a Raspberry Pi imaging sensor for the rapid detection of progesterone in milk samples. We designed, assembled, and tested a standalone portable diagnostic reader and validated it for progesterone detection against a standard ELISA assay using a commercial plate reader. The portable POC device yielded consistent results, regardless of differences in the cameras and flashlights between various smartphone devices. An Android application was built to provide front-end access to users, control the diagnostic reader, and display and store the progesterone measurement on the smartphone. The diagnostic reader takes images of the samples, reads the pixel values, processes the results, and presents the results on the handheld device. The proposed POC reader can perform to superior levels of performance as a plate reader, while adding the desirable qualities of portability and ease of use.

An Audio Jack-Based Electrochemical Impedance Spectroscopy Sensor for Point-of-Care Diagnostics.

PubMed

Jiang, Haowei; Sun, Alex; Venkatesh, A G; Hall, Drew A

2017-02-01

Portable and easy-to-use point-of-care (POC) diagnostic devices hold high promise for dramatically improving public health and wellness. In this paper, we present a mobile health (mHealth) immunoassay platform based on audio jack embedded devices, such as smartphones and laptops, that uses electrochemical impedance spectroscopy (EIS) to detect binding of target biomolecules. Compared to other biomolecular detection tools, this platform is intended to be used as a plug-and-play peripheral that reuses existing hardware in the mobile device and does not require an external battery, thereby improving upon its convenience and portability. Experimental data using a passive circuit network to mimic an electrochemical cell demonstrate that the device performs comparably to laboratory grade instrumentation with 0.3% and 0.5° magnitude and phase error, respectively, over a 17 Hz to 17 kHz frequency range. The measured power consumption is 2.5 mW with a dynamic range of 60 dB. This platform was verified by monitoring the real-time formation of a NeutrAvidin self-assembled monolayer (SAM) on a gold electrode demonstrating the potential for POC diagnostics.

Regulatory perspectives and research activities at the FDA on the use of phantoms with in vivo diagnostic devices

NASA Astrophysics Data System (ADS)

Agrawal, Anant; Gavrielides, Marios A.; Weininger, Sandy; Chakrabarti, Kish; Pfefer, Joshua

2008-02-01

For a number of years, phantoms have been used to optimize device parameters and validate performance in the primary medical imaging modalities (CT, MRI, PET/SPECT, ultrasound). Furthermore, the FDA under the Mammography Quality Standards Act (MQSA) requires image quality evaluation of mammography systems using FDA-approved phantoms. The oldest quantitative optical diagnostic technology, pulse oximetry, also benefits from the use of active phantoms known as patient simulators to validate certain performance characteristics under different clinically-relevant conditions. As such, guidance provided by the FDA to its staff and to industry on the contents of pre-market notification and approval submissions includes suggestions on how to incorporate the appropriate phantoms in establishing device effectiveness. Research at the FDA supports regulatory statements on the use of phantoms by investigating how phantoms can be designed, characterized, and utilized to determine critical device performance characteristics. These examples provide a model for how novel techniques in the rapidly growing field of optical diagnostics can use phantoms during pre- and post-market regulatory testing.

21 CFR 868.1840 - Diagnostic spirometer.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs. (b) Classification. Class II (performance standards). ...

Remote maintenance monitoring system

NASA Technical Reports Server (NTRS)

Simpkins, Lorenz G. (Inventor); Owens, Richard C. (Inventor); Rochette, Donn A. (Inventor)

1992-01-01

A remote maintenance monitoring system retrofits to a given hardware device with a sensor implant which gathers and captures failure data from the hardware device, without interfering with its operation. Failure data is continuously obtained from predetermined critical points within the hardware device, and is analyzed with a diagnostic expert system, which isolates failure origin to a particular component within the hardware device. For example, monitoring of a computer-based device may include monitoring of parity error data therefrom, as well as monitoring power supply fluctuations therein, so that parity error and power supply anomaly data may be used to trace the failure origin to a particular plane or power supply within the computer-based device. A plurality of sensor implants may be rerofit to corresponding plural devices comprising a distributed large-scale system. Transparent interface of the sensors to the devices precludes operative interference with the distributed network. Retrofit capability of the sensors permits monitoring of even older devices having no built-in testing technology. Continuous real time monitoring of a distributed network of such devices, coupled with diagnostic expert system analysis thereof, permits capture and analysis of even intermittent failures, thereby facilitating maintenance of the monitored large-scale system.

21 CFR 868.1100 - Arterial blood sampling kit.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Arterial blood sampling kit. 868.1100 Section 868...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1100 Arterial blood sampling kit. (a) Identification. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples...

21 CFR 876.1800 - Urine flow or volume measuring system.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Urine flow or volume measuring system. 876.1800... (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Diagnostic Devices § 876.1800 Urine flow or volume measuring system. (a) Identification. A urine flow or volume measuring system is a device that...

21 CFR 876.1800 - Urine flow or volume measuring system.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Urine flow or volume measuring system. 876.1800... (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Diagnostic Devices § 876.1800 Urine flow or volume measuring system. (a) Identification. A urine flow or volume measuring system is a device that...

21 CFR 876.1800 - Urine flow or volume measuring system.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Urine flow or volume measuring system. 876.1800... (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Diagnostic Devices § 876.1800 Urine flow or volume measuring system. (a) Identification. A urine flow or volume measuring system is a device that...

21 CFR 876.1800 - Urine flow or volume measuring system.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Urine flow or volume measuring system. 876.1800... (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Diagnostic Devices § 876.1800 Urine flow or volume measuring system. (a) Identification. A urine flow or volume measuring system is a device that...

21 CFR 886.1405 - Ophthalmic trial lens set.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic trial lens set. 886.1405 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1405 Ophthalmic trial lens set. (a) Identification. An ophthalmic trial lens set is a device that is a set of lenses of various dioptric powers...