Interdigitated electrode (IDE) for porcine detection based on titanium dioxide (TiO{sub 2}) thin films

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

Nordin, N.; Azizah, N.; Hashim, U., E-mail: uda@unimap.edu.my

2016-07-06

Interdigited Electrode (IDE) porcine detection can be accomplished to authenticate the halal issue that has been a concern to Muslim not only in Malaysia but all around the world. The method used is photolithography that used the p-type photoresist on the spin coater with 2500 rpm. Bare IDEs device is deposited with Titanium Dioxide (TiO{sub 2}) to improve the performance of the device. The result indicates that current-voltage (I-V) measurement of porcine probe line slightly above porcine target due to negative charges repelled each other. The IDE device can detect the porcine presence in food as lowest as 1.0 µM.more » Better performance of the device can be achieved with the replacement of gold deposited to trigger more sensitivity of the device.« less

Surgical Treatment for Discogenic Low-Back Pain: Lumbar Arthroplasty Results in Superior Pain Reduction and Disability Level Improvement Compared With Lumbar Fusion

PubMed Central

2007-01-01

Background The US Food and Drug Administration approved the Charité artificial disc on October 26, 2004. This approval was based on an extensive analysis and review process; 20 years of disc usage worldwide; and the results of a prospective, randomized, controlled clinical trial that compared lumbar artificial disc replacement to fusion. The results of the investigational device exemption (IDE) study led to a conclusion that clinical outcomes following lumbar arthroplasty were at least as good as outcomes from fusion. Methods The author performed a new analysis of the Visual Analog Scale pain scores and the Oswestry Disability Index scores from the Charité artificial disc IDE study and used a nonparametric statistical test, because observed data distributions were not normal. The analysis included all of the enrolled subjects in both the nonrandomized and randomized phases of the study. Results Subjects from both the treatment and control groups improved from the baseline situation (P < .001) at all follow-up times (6 weeks to 24 months). Additionally, these pain and disability levels with artificial disc replacement were superior (P < .05) to the fusion treatment at all follow-up times including 2 years. Conclusions The a priori statistical plan for an IDE study may not adequately address the final distribution of the data. Therefore, statistical analyses more appropriate to the distribution may be necessary to develop meaningful statistical conclusions from the study. A nonparametric statistical analysis of the Charité artificial disc IDE outcomes scores demonstrates superiority for lumbar arthroplasty versus fusion at all follow-up time points to 24 months. PMID:25802574

Integrated titanium dioxide (TiO2) nanoparticles on interdigitated device electrodes (IDEs) for pH analysis

NASA Astrophysics Data System (ADS)

Azizah, N.; Hashim, U.; Arshad, M. K. Md.; Gopinath, Subash C. B.; Nadzirah, Sh.; Farehanim, M. A.; Fatin, M. F.; Ruslinda, A. R.; Ayub, R. M.

2016-07-01

Titanium dioxide (TiO2) nanoparticles based Interdigitated Device Electrodes (IDEs) Nanobiosensor device was developed for intracellular biochemical detection. Fabrication and characterization of pH sensors using IDE nanocoated with TiO2 was studied in this paper. In this paper, a preliminary assessment of this intracellular sensor with electrical measurement under different pH levels. 3-aminopropyltriethoxysilane (APTES) was used to enhance the sensitivity of titanium dioxide layer as well as able to provide surface modification by undergoing protonation and deprotonation process. Different types of pH solution provide different resistivity and conductivity towards the surface. Base solution has the higher current compared to an acid solution. Amine and oxide functionalized TiO2 based IDE exhibit pH-dependent could be understood in terms of the change in surface charge during protonation and deprotonation. The simple fabrication process, high sensitivity, and fast response of the TiO2 based IDEs facilitate their applications in a wide range of areas. The small size of semiconductor TiO2 based IDE for sensitive, label-free, real time detection of a wide range of biological species could be explored in vivo diagnostics and array-based screening.

Marketing approval for the lithotripter.

PubMed

Nightingale, S L; Young, F E

1986-01-01

In December 1984, the Food and Drug Administration (FDA) granted Dornier Systems (FRG) approval to market the external shock wave lithotripter (ESWL) in the USA. The Medical Device Amendments of the Food, Drug, and Cosmetic Act require that the FDA evaluate the safety and effectiveness of medical devices intended for commercial distribution in the U.S. Such evaluation includes basic scientific studies, animal testing, and investigational studies in human subjects, culminating in a judgment concerning acceptable risks in terms of anticipated benefits, and whether the device is effective for its intended use. Prior to human studies in West Germany, Dornier had evaluated the destruction of stones of varying composition, measured the rate and energy of stone destruction, and tested blood samples and lymphocyte cultures exposed to shock waves. In addition, studies in both rats and dogs had demonstrated the feasibility of the technique and evidence of safety. Such data are provided by manufacturers when applying for an investigational device exemption (IDE) from the FDA, which permits clinical studies in humans; such studies also require the approval of an Institutional Review Board. The FDA approved Dornier's IDE, allowing human investigational use of the ESWL in facilities in the U.S., conducted concurrently with similar studies in West Germany. Upon completion of clinical trials, data acquired in vitro, in laboratory animals, and in human investigations are submitted to the FDA for a premarked approval application (PMAA). The Agency was given 6 months to make a decision, taking into consideration the recommendation of an advisory panel of experts from outside the Agency who had reviewed the same data. In its evaluation of the ESWL for safety and effectiveness, the FDA considered the question of alternative practices and procedures to treat nephrolithiasis, including percutaneous nephrolithotomy and open surgical procedures, and the adverse effects of such procedures. Clinical data available at the time of review for approval included reports of treatment of 667 patients in West German centers, and 327 patients treated in three U.S. facilities. Dornier and the FDA initiated discussions concerning the labeling of the device and a postmarketing surveillance plan. These were completed and marketing approval for the ESWL was granted.

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

Azizah, N., E-mail: norazizahparmin84@gmail.com; Gopinath, Subash C. B.; Nadzirah, Sh.

Titanium dioxide (TiO{sub 2}) nanoparticles based Interdigitated Device Electrodes (IDEs) Nanobiosensor device was developed for intracellular biochemical detection. Fabrication and characterization of pH sensors using IDE nanocoated with TiO{sub 2} was studied in this paper. In this paper, a preliminary assessment of this intracellular sensor with electrical measurement under different pH levels. 3-aminopropyltriethoxysilane (APTES) was used to enhance the sensitivity of titanium dioxide layer as well as able to provide surface modification by undergoing protonation and deprotonation process. Different types of pH solution provide different resistivity and conductivity towards the surface. Base solution has the higher current compared to anmore » acid solution. Amine and oxide functionalized TiO{sub 2} based IDE exhibit pH-dependent could be understood in terms of the change in surface charge during protonation and deprotonation. The simple fabrication process, high sensitivity, and fast response of the TiO{sub 2} based IDEs facilitate their applications in a wide range of areas. The small size of semiconductor TiO{sub 2} based IDE for sensitive, label-free, real time detection of a wide range of biological species could be explored in vivo diagnostics and array-based screening.« less

Study of surface functionalization on IDE by using 3-aminopropyl triethoxysilane (APTES) for cervical cancer detection

NASA Astrophysics Data System (ADS)

Raqeema, S.; Hashim, U.; Azizah, N.

2016-07-01

This paper presented the study of surface functionalization on IDE by using 3-Aminopropyl triethoxysilane (APTES). The DNA nanochip based interdigitated (IDE) has been proposed to optimized the sensitivity of the device due to the cervical cancer detection. The DNA nanochip will be more efficient using surface modification of TiO2 nanoparticles with 3-Aminopropyl triethoxysilane (APTES). Furthermore, APTES gain the better functionalization of the adsorption mechanism on IDE. The combination of the DNA probe and the HPV target will produce more sensitivity and speed of the DNA nanochip due to their properties. The IDE has been characterized using current-voltage (IV) measurement. This functionalization of the surface would be applicable, sensitive, selective and low cost for cervical cancer detection.

The Food and Drug Administration and pragmatic clinical trials of marketed medical products

PubMed Central

Anderson, Monique L; Griffin, Joseph; Goldkind, Sara F; Zeitler, Emily P; Wing, Liz; Al-Khatib, Sana M; Sherman, Rachel E

2015-01-01

Pragmatic clinical trials (PCTs) can help answer questions of comparative effectiveness for interventions routinely used in medical practice. PCTs may examine outcomes of one or more marketed medical products, and they are heterogeneous in design and risk. The Food and Drug Administration (FDA) is charged with protecting the rights, safety, and welfare of individuals enrolled in clinical investigations, as well as assuring the integrity upon which approval of medical products are made. The FDA has broad jurisdiction over drugs and medical devices (whether or not they are approved for marketing), and as such, clinical investigations of these products are subject to applicable FDA regulations. While many PCTs will meet the criteria for an exemption from the requirements for an investigational new drug application (IND) or investigational device exemption (IDE), in general all clinical investigations of medical products that fall under FDA jurisdiction must adhere to regulations for informed consent and review by an institutional review board (IRB). We are concerned that current FDA requirements for obtaining individual informed consent may deter or delay the conduct of PCTs intended to develop reliable evidence of comparative safety and effectiveness of approved medical products that are regulated by the FDA. Under current regulations, there are no described mechanisms to alter or waive informed consent to make it less burdensome or more practicable for low-risk PCTs. We recommend that the FDA establish a risk-based approach to obtaining informed consent in PCTs that would facilitate the conduct of PCTs without compromising the protection of enrolled individuals or the integrity of the resulting data. PMID:26374684

A meta-analysis of comparative outcomes following cervical arthroplasty or anterior cervical fusion: results from 4 prospective multicenter randomized clinical trials and up to 1226 patients.

PubMed

McAfee, Paul C; Reah, Chris; Gilder, Kye; Eisermann, Lukas; Cunningham, Bryan

2012-05-15

Meta-analysis of 4 prospective randomized controlled Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical trials. To maximize the information available from 4 IDE studies by analyzing the combined outcomes of cervical arthroplasty versus fusion at 24-month follow-up. To date, 4 randomized clinical trials have been completed in the United States under FDA IDE protocols to study cervical arthroplasty. Each trial reported arthroplasty to be at least as successful as fusion controls based on noninferiority trial designs. However, sample sizes in any given trial may not be sufficient to demonstrate superiority of treatment effect. Meta-analysis enables pooling of results from comparable trials, which may lead to more precise and statistically significant estimates of treatment effect. Four cervical arthroplasty randomized clinical trials with comparable enrollment criteria and outcome measures were conducted independently by 3 separate sponsors to study the following devices: Bryan, Prestige, ProDisc-C, and PCM cervical disc replacements. A total of 1608 patients were treated across 98 investigative sites. Data were available for 1352 treated patients, of which 1226 were evaluable at 24 months. Assessments included clinical success definitions based on neck disability index, maintenance or improvement of neurological status, subsequent surgery or intervention at the index level (survivorship), and a composite score comprising these as well as serious device-related adverse events. Trial endpoint comparisons were made at 24 months postoperatively. For each endpoint, a random-effects meta-analysis was performed to compare the success rates of cervical arthroplasty with anterior cervical discectomy and fusion (ACDF). Also, supportive frequentist and bayesian analyses were performed. The pooled primary overall success results indicated a statistically significant treatment effect favoring arthroplasty compared with ACDF. Overall success was achieved by 77.6% of the arthroplasty patients and by 70.8% of the ACDF patients (pooled odds ratio [OR]: 0.699, 95% confidence interval [CI]: 0.539-0.908, P = 0.007). The results of the individual subcomponent meta-analyses, all of which favored arthroplasty, were neck disability index success (OR: 0.786, 95% CI: 0.589-1.050, P = 0.103), neurological status (OR: 0.552, 95% CI: 0.364-0.835, P = 0.005), and survivorship (OR: 0.510, 95% CI: 0.275-0.946, P = 0.033). Only the survivorship endpoint suggested low heterogeneity. These findings suggest that cervical arthroplasty is superior to ACDF in overall success, neurological success, and survivorship outcomes at 24 months postoperatively.

The Asfora Bullet Cage System Shows Comparable Fusion Rate Success Versus Control Cage in Posterior Lumbar Interbody Fusion in a Randomized Clinical Trial.

PubMed

Morgan, Jeremy P; Miller, Ashley L; Thompson, Paul A; Asfora, Wilson T

2016-04-01

Low back pain and degeneration of the intervertebral disc are an integrated malady that affects millions of Americans. Cage devices used in association with posterior lumbar interbody fusion (PLIF) have been shown to be an effective approach in the treatment of a number of lower spine disorders attributed to degenerative disc disease (DDD). This study was undertaken as part of a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study and compares the effectiveness of the Asfora Bullet Cage System (ABCS) to successfully fuse vertebra at one or two levels between L2 and S1 in patients with DDD to an FDA approved comparison device, the Medtronic-Sofamor Danek Inter Fix Threaded Fusion Device (MSDIFD). A total of 257 randomized participants were implanted with either the ABCS device (n = 132) or the MSDIFD device (n = 125) through an open posterior approach using autogenous local bone graft without the use of pedicle screws. Patients were evaluated prior to surgery and at the 24 month (24-M) visit for fusion status, deep tendon reflex status, sensory function, motor function, straight leg raise status, pain, disability, and device safety. Radiological evaluation and statistical analysis were performed by independent professionals. Evaluation of device success was performed at 24-M visit. From the original group of 257 patients, 59 were lost to follow-up. Primary measures of success at the 24-M visit involved pain and function, fusion, neurological status, and device-related adverse events measures. Pain and function improved in both (MSDIFD: 75.7 percent; ABCS: 82.6 percent). Fusion success with all radiographic points at 24-M visits was 79.4 percent MSDIFD and 88.2 percent ABCS. Neurological improvement was seen in both (MSDIFD: 77.0 percent; ABCS: 87.8 percent). One device-related grade 1 adverse event was reported in the MSDIFD group. Disc height preservation was equivalent for single level fusions (MSDIFD: 16.1 percent; ABCS: 20.0 percent) and second level fusions (MSDIFD: 10.7 percent; ABCS: 14.3 percent). General health and well-being improvement was the same (MSDIFD: 37.0 percent; ABCS: 40.0 percent). Subsequent fusion, up to 10 years, was equivalent (MSDIFD: 83.8 percent; ABCS: 91.2). Results for both devices were considered to be satisfactory, with a slight non-significant superiority for the ABCS. From the ABCS device FDA IDE sanctioned study and the review of the literature, we concluded that the Asfora Bullet Cage System is safe, effective and comparable to other interbody fusion devices which are used stand-alone or in conjunction with pedicle screws, rhBMP-2, or autogenous bone harvested from the iliac crest inserted through anterior, lateral or posterior approaches.

9.4T Human MRI: Preliminary Results

PubMed Central

Vaughan, Thomas; DelaBarre, Lance; Snyder, Carl; Tian, Jinfeng; Akgun, Can; Shrivastava, Devashish; Liu, Wanzahn; Olson, Chris; Adriany, Gregor; Strupp, John; Andersen, Peter; Gopinath, Anand; van de Moortele, Pierre-Francois; Garwood, Michael; Ugurbil, Kamil

2014-01-01

This work reports the preliminary results of the first human images at the new high-field benchmark of 9.4T. A 65-cm-diameter bore magnet was used together with an asymmetric 40-cm-diameter head gradient and shim set. A multichannel transmission line (transverse electromagnetic (TEM)) head coil was driven by a programmable parallel transceiver to control the relative phase and magnitude of each channel independently. These new RF field control methods facilitated compensation for RF artifacts attributed to destructive interference patterns, in order to achieve homogeneous 9.4T head images or localize anatomic targets. Prior to FDA investigational device exemptions (IDEs) and internal review board (IRB)-approved human studies, preliminary RF safety studies were performed on porcine models. These data are reported together with exit interview results from the first 44 human volunteers. Although several points for improvement are discussed, the preliminary results demonstrate the feasibility of safe and successful human imaging at 9.4T. PMID:17075852

Experimental characterization of PZT fibers using IDE electrodes

NASA Astrophysics Data System (ADS)

Wyckoff, Nicholas; Ben Atitallah, Hassene; Ounaies, Zoubeida

2016-04-01

Lead zirconate titanate (PZT) fibers are mainly used in active fiber composites (AFC) where they are embedded in a polymer matrix. Interdigitated electrodes (IDE) along the direction of the fibers are used to achieve planar actuation, hereby exploiting the d33 coefficient of PZT. When embedded in the AFC, the PZT fibers are subjected to mechanical loading as well as non-uniform electric field as a result of the IDEs. Therefore, it is important to characterize the electrical and electromechanical behavior of these fibers ex-situ using the IDE electrodes to assess the impact of nonuniform electric field on the properties of the fibers. For that reason, this work aims at quantifying the impact of IDE electrodes on the electrical and electromechanical behavior of PZT fibers, which is necessary for their successful implementation in devices like AFC. The tested fibers were purchased from Advanced Cerametrics and they have an average diameter of 250 micrometers. The IDE electrodes were screen printed on an acrylic substrate. The PZT fibers were subjected to frequency sweeps at low voltages to determine permittivity for parallel and interdigitated electrodes. The piezoelectric e33 constant is determined from electromechanical testing of PZT fibers in parallel electrodes to compare the electromechanical behavior for PZT in bulk and fiber form. The dielectric constant and e33 were found to be lower for the IDE and parallel electrodes compared to bulk but comparable to results published in literature.

Medical devices; exemptions from premarket notification; class II devices--FDA, Final rule.

PubMed

1998-11-03

The Food and Drug Administration (FDA) is codifying the exemption from premarket notification of all 62 class II (special controls) devices listed as exempt in a January 21, 1998, Federal Register notice, subject to the limitations on exemptions. FDA has determined that for these exempted devices, manufacturers' submissions of premarket notifications are unnecessary to provide a reasonable assurance of safety and effectiveness. These devices will remain subject to current good manufacturing practice (CGMP) regulations and other general controls. This rulemaking implements new authorities delegated to FDA under the Food and Drug Administration Modernization Act (FDAMA).

21 CFR 801.110 - Retail exemption for prescription devices.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Retail exemption for prescription devices. 801.110 Section 801.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.110 Retail exemption...

21 CFR 801.110 - Retail exemption for prescription devices.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Retail exemption for prescription devices. 801.110 Section 801.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.110 Retail exemption...

21 CFR 801.110 - Retail exemption for prescription devices.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Retail exemption for prescription devices. 801.110 Section 801.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.110 Retail exemption...

21 CFR 801.110 - Retail exemption for prescription devices.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Retail exemption for prescription devices. 801.110 Section 801.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.110 Retail exemption...

21 CFR 801.110 - Retail exemption for prescription devices.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Retail exemption for prescription devices. 801.110 Section 801.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.110 Retail exemption...

42 CFR 405.203 - FDA categorization of investigational devices.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 2 2010-10-01 2010-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental...

42 CFR 405.203 - FDA categorization of investigational devices.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 2 2014-10-01 2014-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental...

42 CFR 405.203 - FDA categorization of investigational devices.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 2 2013-10-01 2013-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental...

42 CFR 405.203 - FDA categorization of investigational devices.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 2 2011-10-01 2011-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental...

42 CFR 405.203 - FDA categorization of investigational devices.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 2 2012-10-01 2012-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental...

Why Lumbar Artificial Disk Replacements (LADRs) Fail.

PubMed

Pettine, Kenneth; Ryu, Robert; Techy, Fernando

2017-07-01

A retrospective review of prospectively collected data. To determine why artificial disk replacements (ADRs) fail by examining results of 91 patients in FDA studies performed at a single investigational device exemption (IDE) site with minimum 2-year follow-up. Patients following lumbar ADR generally achieve their 24-month follow-up results at 3 months postoperatively. Every patient undergoing ADR at 1 IDE site by 2 surgeons was evaluated for clinical success. Failure was defined as <50% improvement in ODI and VAS or any additional surgery at index or adjacent spine motion segment. Three ADRs were evaluated: Maverick, 25 patients; Charité, 31 patients; and Kineflex, 35 patients. All procedures were 1-level operations performed at L4-L5 or L5-S1. Demographics and inclusion/exclusion criteria were similar and will be discussed. Overall clinical failure occurred in 26% (24 of 91 patients) at 2-year follow-up. Clinical failure occurred in: 28% (Maverick) (7 of 25 patients), 39% (Charité) (12 of 31 patients), and 14% (Kineflex) (5 of 35 patients). Causes of failure included facet pathology, 50% of failure patients (12 of 24). Implant complications occurred in 5% of total patients and 21% of failure patients (5 of 24). Only 5 patients went from a success to failure after 3 months. Only 1 patient went from a failure to success after a facet rhizotomy 1 year after ADR. Seventy-four percent of patients after ADR met strict clinical success after 2-year follow-up. The clinical success versus failure rate did not change from their 3-month follow-up in 85 of the 91 patients (93%). Overall clinical success may be improved most by patient selection and implant type.

Measurement of effective piezoelectric coefficients of PZT thin films for energy harvesting application with interdigitated electrodes.

PubMed

Chidambaram, Nachiappan; Mazzalai, Andrea; Muralt, Paul

2012-08-01

Interdigitated electrode (IDE) systems with lead zirconate titanate (PZT) thin films play an increasingly important role for two reasons: first, such a configuration generates higher voltages than parallel plate capacitor-type electrode (PPE) structures, and second, the application of an electric field leads to a compressive stress component in addition to the overall stress state, unlike a PPE structure, which results in tensile stress component. Because ceramics tend to crack at relatively moderate tensile stresses, this means that IDEs have a lower risk of cracking than PPEs. For these reasons, IDE systems are ideal for energy harvesting of vibration energy, and for actuators. Systematic investigations of PZT films with IDE systems have not yet been undertaken. In this work, we present results on the evaluation of the in-plane piezoelectric coefficients with IDE systems. Additionally, we also propose a simple and measurable figure of merit (FOM) to analyze and evaluate the relevant piezoelectric parameter for harvesting efficiency without the need to fabricate the energy harvesting device. Idealized effective coefficients e(IDE) and h(IDE) are derived, showing its composite nature with about one-third contribution of the transverse effect, and about two-thirds contribution of the longitudinal effect in the case of a PZT film deposited on a (100)-oriented silicon wafer with the in-plane electric field along one of the <011> Si directions. Randomly oriented 1-μm-thick PZT 53/47 film deposited by a sol-gel technique, was evaluated and yielded an effective coefficient e(IDE) of 15 C·m(-2). Our FOM is the product between effective e and h coefficient representing twice the electrical energy density stored in the piezoelectric film per unit strain deformation (both for IDE and PPE systems). Assuming homogeneous fields between the fingers, and neglecting the contribution from below the electrode fingers, the FOM for IDE structures with larger electrode gap is derived to be twice as large as for PPE structures, for PZT-5H properties. The experiments yielded an FOM of the IDE structures of 1.25 × 10(10) J/m(3) and 14 mV/μ strain.

Sensitivity enhancement of capacitive tumor necrosis factor-α detection by deposition of nanoparticles on interdigitated electrode

NASA Astrophysics Data System (ADS)

Yagati, Ajay Kumar; Park, Jinsoo; Kim, Jungsuk; Ju, Heongkyu; Chang, Keun-A.; Cho, Sungbo

2016-06-01

An interdigitated electrodes (IDE) modified with gold nanoparticles (AuNPs) was fabricated to enhance the capacitive detection of tumor necrosis factor-α (TNF-α) and compared with a bare IDE. A TNF-α immunosensor was developed by covalently conjugating TNF-α antibodies with 3-mercaptopropionic acid by a carbodiimide/N-hydroxysuccinimide reaction on the AuNP/IDE. After the application of human serum samples containing various concentrations of TNF-α to the sensing electrode, changes in both the impedance spectrum and the electrode interfacial capacitance were measured. The capacitance changes were dependent on the TNF-α concentration in the range of 1 pg ml-1 to 10 ng ml-1, and the device had the calculated detection limit of 0.83 pg ml-1. The developed AuNP/IDE-based immunosensor was successfully used for the capacitive detection of the binding of TNF-α to its antibody, and was found to be feasible for the analysis of TNF-α in human blood serum.

76 FR 50663 - Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-16

... completion of a PDP is not filed by the latter of the two dates, and no IDE is in effect, the device is... availability of a preamendments class III devices strategy document. The strategy document set forth FDA's... approved PMA or a declared completed PDP is required to be in effect for any such devices on or before 180...

AC electrokinetic drug delivery in dentistry using an interdigitated electrode assembly powered by inductive coupling.

PubMed

Ivanoff, Chris S; Wu, Jie Jayne; Mirzajani, Hadi; Cheng, Cheng; Yuan, Quan; Kevorkyan, Stepan; Gaydarova, Radostina; Tomlekova, Desislava

2016-10-01

AC electrokinetics (ACEK) has been shown to deliver certain drugs into human teeth more effectively than diffusion. However, using electrical wires to power intraoral ACEK devices poses risks to patients. The study demonstrates a novel interdigitated electrode arrays (IDE) assembly powered by inductive coupling to induce ACEK effects at appropriate frequencies to motivate drugs wirelessly. A signal generator produces the modulating signal, which multiplies with the carrier signal to produce the amplitude modulated (AM) signal. The AM signal goes through the inductive link to appear on the secondary coil, then rectified and filtered to dispose of its carrier signal, and the positive half of the modulating signal appears on the load. After characterizing the device, the device is validated under light microscopy by motivating carboxylate-modified microspheres, tetracycline, acetaminophen, benzocaine, lidocaine and carbamide peroxide particles with induced ACEK effects. The assembly is finally tested in a common dental bleaching application. After applying 35 % carbamide peroxide to human teeth topically or with the IDE at 1200 Hz, 5 Vpp for 20 min, spectrophotometric analysis showed that compared to diffusion, the IDE enhanced whitening in specular optic and specular optic excluded modes by 215 % and 194 % respectively. Carbamide peroxide absorbance by the ACEK group was two times greater than diffusion as measured by colorimetric oxidation-reduction and UV-Vis spectroscopy at 550 nm. The device motivates drugs of variable molecular weight and structure wirelessly. Wireless transport of drugs to intraoral targets under ACEK effects may potentially improve the efficacy and safety of drug delivery in dentistry.

78 FR 60291 - Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-01

...] Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY... Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.'' Through the...

77 FR 32642 - Medical Devices; Exemption From Premarket Notification: Powered Patient Transport

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-01

...] Medical Devices; Exemption From Premarket Notification: Powered Patient Transport AGENCY: Food and Drug... transport devices commonly known as stairlifts. These devices are used to assist transfers of a mobility... behalf of Bruno Independent Living Aids, Inc., for powered patient transport devices (commonly known as...

Long-term bilayer encapsulation performance of atomic layer deposited Al₂O₃ and Parylene C for biomedical implantable devices.

PubMed

Xie, Xianzong; Rieth, Loren; Caldwell, Ryan; Diwekar, Mohit; Tathireddy, Prashant; Sharma, Rohit; Solzbacher, Florian

2013-10-01

We present an encapsulation scheme that combines atomic layer deposited (ALD) Al₂O₃ and Parylene C for the encapsulation of implantable devices. The encapsulation performances of combining alumina and Parylene C was compared to individual layers of Parylene C or alumina and the bilayer coating had superior encapsulation properties. The alumina-Parylene coated interdigitated electrodes (IDEs) soaked in PBS for up to nine months at temperatures from 37 to 80 °C for accelerated lifetime testing. For 52-nm alumina and 6-μm Parylene C, leakage current was ∼20 pA at 5 VDC, and the impedance was about 3.5 MΩ at 1 kHz with a phase near -87° from electrochemical impedance spectroscopy for samples soaked at 67 °C for equivalent lifetime of 72 months at 37 °C. The change of impedance during the whole soaking period (up to 70 months of equivalent soaking time at 37 °C) over 1 to 10⁶ Hz was within 5%. The stability of impedance indicated almost no degradation of the encapsulation. Bias voltage effect was studied by continuously applying 5 VDC, and it reduced the lifetime of Parylene coating by ∼75% while it showed no measurable effect on the bilayer coating. Lifetime of encapsulation of IDEs with topography generated by attaching a coil and surface mount device (SMD) capacitor was about half of that of planer IDEs. The stable long-term insulation impedance, low leakage current, and better lifetime under bias voltage and topography made this double-layer encapsulation very promising for chronic implantable devices.

40 CFR 63.2251 - What are the requirements for the routine control device maintenance exemption?

Code of Federal Regulations, 2010 CFR

2010-07-01

... the routine control device maintenance exemption? (a) You may request a routine control device..., explain why the maintenance cannot be accomplished during process shutdowns, describe how you plan to make... device is used to control a green rotary dryer, tube dryer, rotary strand dryer, or pressurized refiner...

75 FR 2869 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-19

... life-threatening or serious conditions for which no comparable or satisfactory alternative therapy is... IDE, to assess the sponsor's due diligence in obtaining marketing clearance of the device and to...

Medical devices; exemption from premarket notification; Class II devices; optical impression systems for computer assisted design and manufacturing. Final rule.

PubMed

2003-04-22

The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for data acquisition units for ceramic dental restoration systems. This rule exempts from premarket notification data acquisition units for ceramic dental restoration systems and establishes a guidance document as a special control for this device. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA).

Substrate effects in high gain, low operating voltage SnSe2 photoconductor

NASA Astrophysics Data System (ADS)

Krishna, Murali; Kallatt, Sangeeth; Majumdar, Kausik

2018-01-01

High gain photoconductive devices find wide spread applications in low intensity light detection. Ultra-thin layered materials have recently drawn a lot of attention from researchers in this regard. However, in general, a large operating voltage is required to obtain large responsivity in these devices. In addition, the characteristics are often confounded by substrate induced trap effects. Here we report multi-layer SnSe2 based photoconductive devices using two different structures: (1) SiO2 substrate supported inter-digitated electrode (IDE), and (2) suspended channel. The IDE device exhibits a responsivity of ≈ {10}3 A W-1 and ≈ 8.66× {10}4 A W-1 at operating voltages of 1 mV and 100 mV, respectively—a superior low voltage performance over existing literature on planar 2D structures. However, the responsivity reduces by more than two orders of magnitude, while the transient response improves for the suspended device—providing insights into the critical role played by the channel-substrate interface in the gain mechanism. The results, on one hand, are promising for highly sensitive photoconductive applications consuming ultra-low power, and on the other hand, show a generic methodology that could be applied to other layered material based photoconductive devices as well for extracting the intrinsic behavior.

76 FR 69321 - Petition to Modify an Exemption of a Previously Approved Antitheft Device; Porsche

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-08

... DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration Petition to Modify an Exemption of a Previously Approved Antitheft Device; Porsche AGENCY: National Highway Traffic Safety... previously approved antitheft device. SUMMARY: On May 25, 1989, the National Highway Traffic Safety...

21 CFR 807.65 - Exemptions for device establishments.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., who manufacture or otherwise alter devices solely for use in their practice. (e) Pharmacies, surgical.... This exemption also applies to a pharmacy or other similar retail establishment that purchases a device... bandage or crutch, indicating “distributed by” or “manufactured for” followed by the name of the pharmacy...

21 CFR 807.65 - Exemptions for device establishments.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., who manufacture or otherwise alter devices solely for use in their practice. (e) Pharmacies, surgical.... This exemption also applies to a pharmacy or other similar retail establishment that purchases a device... bandage or crutch, indicating “distributed by” or “manufactured for” followed by the name of the pharmacy...

21 CFR 807.65 - Exemptions for device establishments.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., who manufacture or otherwise alter devices solely for use in their practice. (e) Pharmacies, surgical.... This exemption also applies to a pharmacy or other similar retail establishment that purchases a device... bandage or crutch, indicating “distributed by” or “manufactured for” followed by the name of the pharmacy...

21 CFR 807.65 - Exemptions for device establishments.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., who manufacture or otherwise alter devices solely for use in their practice. (e) Pharmacies, surgical.... This exemption also applies to a pharmacy or other similar retail establishment that purchases a device... bandage or crutch, indicating “distributed by” or “manufactured for” followed by the name of the pharmacy...

21 CFR 807.65 - Exemptions for device establishments.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., who manufacture or otherwise alter devices solely for use in their practice. (e) Pharmacies, surgical.... This exemption also applies to a pharmacy or other similar retail establishment that purchases a device... bandage or crutch, indicating “distributed by” or “manufactured for” followed by the name of the pharmacy...

Simulations of Interdigitated Electrode Interactions with Gold Nanoparticles for Impedance-Based Biosensing Applications

PubMed Central

MacKay, Scott; Hermansen, Peter; Wishart, David; Chen, Jie

2015-01-01

In this paper, we describe a point-of-care biosensor design. The uniqueness of our design is in its capability for detecting a wide variety of target biomolecules and the simplicity of nanoparticle enhanced electrical detection. The electrical properties of interdigitated electrodes (IDEs) and the mechanism for gold nanoparticle-enhanced impedance-based biosensor systems based on these electrodes are simulated using COMSOL Multiphysics software. Understanding these properties and how they can be affected is vital in designing effective biosensor devices. Simulations were used to show electrical screening develop over time for IDEs in a salt solution, as well as the electric field between individual digits of electrodes. Using these simulations, it was observed that gold nanoparticles bound closely to IDEs can lower the electric field magnitude between the digits of the electrode. The simulations are also shown to be a useful design tool in optimizing sensor function. Various different conditions, such as electrode dimensions and background ion concentrations, are shown to have a significant impact on the simulations. PMID:26364638

40 CFR 157.24 - Exemptions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Exemptions. 157.24 Section 157.24 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS PACKAGING REQUIREMENTS FOR PESTICIDES AND DEVICES Child-Resistant Packaging § 157.24 Exemptions. (a) General exemptions...

21 CFR 822.30 - May I request exemption from the requirement to conduct postmarket surveillance?

Code of Federal Regulations, 2011 CFR

2011-04-01

..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Waivers and... model of that device at any time. You must comply with the requirements of this part unless and until we... exempt the device or model from postmarket surveillance. You should demonstrate why the surveillance...

21 CFR 822.30 - May I request exemption from the requirement to conduct postmarket surveillance?

Code of Federal Regulations, 2010 CFR

2010-04-01

..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Waivers and... model of that device at any time. You must comply with the requirements of this part unless and until we... exempt the device or model from postmarket surveillance. You should demonstrate why the surveillance...

Electrical immunosensor based on a submicron-gap interdigitated electrode and gold enhancement.

PubMed

Ahn, Junhyoung; Lee, Tae Han; Li, Taihua; Heo, Kwang; Hong, Seunghun; Ko, Jeongheon; Kim, Yongsam; Shin, Yong-Beom; Kim, Min-Gon

2011-08-15

We demonstrated that the detection of human interleukin 5 (IL5) with a higher sensitivity than the enzyme-linked immunosorbent assay (ELISA) was possible using mass-producible submicron-gap interdigitated electrodes (IDEs) combined with signal amplification by a gold nanoparticle (AuNP) and gold enhancement. IDEs, facing comb-shape electrodes, can act as simple and miniaturized devices for immunoassay. An IDE with a gap size of 400nm was fabricated by a stepper photolithography process and was applied for the immunoassay of human IL5. A biotinylated anti-human IL5 was immobilized on the streptavidin-modified IDE, and biotin-bovine serum albumin (BSA) and BSA were added sequentially to reduce non-specific binding between the streptavidin-immobilized IDE surface and other proteins. The immunoassay procedure included three main steps: the reaction of human IL5 to form antigen-antibody complexes, the binding of AuNP conjugation with an antibody against human IL5 for the sandwich immunoassay, and gold enhancement for electrical signal amplification. The measurement of electrical current at each step showed that the gold enhancement step was very critical in detection of the concentration of human IL5. Analysis by scanning electron microscope (SEM) showed that close to 1μm particles were formed from 10nm AuNP by the gold enhancement reaction using gold ions and hydroxylamine. Under optimized conditions, human IL5 could be analyzed at 1pgmL(-1) with a wide dynamic range (from 10(-3) to 100ngmL(-1) concentrations). Copyright © 2011 Elsevier B.V. All rights reserved.

21 CFR 814.104 - Original applications.

Code of Federal Regulations, 2014 CFR

2014-04-01

... the Center for Biologics Evaluation and Research, send this information to the Document Control Center... and Research, send this information to the Central Document Control Room, Center for Drug Evaluation... device under an approved IDE) is available to treat or diagnose the disease or condition. The application...

9 CFR 317.400 - Exemption from nutrition labeling.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Exemption from nutrition labeling. 317... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.400 Exemption from nutrition labeling. (a) The following meat or meat food products are exempt from nutrition...

9 CFR 317.400 - Exemption from nutrition labeling.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Exemption from nutrition labeling. 317... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.400 Exemption from nutrition labeling. (a) The following meat or meat food products are exempt from nutrition...

9 CFR 317.400 - Exemption from nutrition labeling.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Exemption from nutrition labeling. 317... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.400 Exemption from nutrition labeling. (a) The following meat or meat food products are exempt from nutrition...

78 FR 14013 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-04

...: General Requirements for Safety-- Collateral Standard: Electromagnetic Compatibility--Requirements and... electromagnetic compatibility and electrical safety. Firms are now exempt from 510(k) requirements for vertical... Equipment--Part 1-2: General Requirements for Safety--Collateral Standard: Electromagnetic Compatibility...

Alternative Fuels Data Center

Science.gov Websites

Idle Reduction Equipment Excise Tax Exemption Qualified on-board idle reduction devices and advanced insulation are exempt from the federal excise tax imposed on the retail sale of heavy-duty highway ) SmartWay Technology Program Federal Excise Tax Exemption website. The exemption applies to equipment that

78 FR 35937 - Food and Drug Administration Decisions for Investigational Device Exemption Clinical...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-14

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0790] Food and Drug Administration Decisions for Investigational Device Exemption Clinical Investigations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug...

21 CFR 812.19 - Address for IDE correspondence.

Code of Federal Regulations, 2011 CFR

2011-04-01

... and Radiological Health, Document Mail Center, 10903 New Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993-0002. (2) For devices regulated by the Center for Biologics Evaluation and Research, send it to the Document Control Center (HFM-99), Center for Biologics Evaluation and Research, Food and...

78 FR 14557 - Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0010] Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption Guidance for Retinal Prostheses; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

78 FR 23941 - Pilot Program for Early Feasibility Study Investigational Device Exemption Applications...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-23

...] Pilot Program for Early Feasibility Study Investigational Device Exemption Applications; Extending the... 13343), FDA terminated the acceptance of applications into the program and extended the pilot program for the nine accepted sponsors until May 8, 2013. The pilot program will be further extended for the...

Fabrication and energy harvesting characteristics of unimorph piezoelectric cantilever generators with interdigitated electrode lead zirconate titanate laminates

NASA Astrophysics Data System (ADS)

Lee, Min-seon; Yun, Ji-sun; Park, Woon-ik; Hong, Youn-woo; Cho, Jeong-ho; Paik, Jong-hoo; Park, Yong Ho; Son, Chun-myung; Jeong, Young Hun

2017-12-01

Interdigitated electrode (IDE) unimorph piezoelectric cantilever generators (UPCGs) were fabricated and their energy harvesting characteristics were investigated. A hard lead zirconate titanate (PZT) material with a high mechanical quality factor (Q m) of 1280 was used for the active piezoelectric film of the IDE UPCGs. Two different laminated IDE UPCGs were prepared; one has Ag/Pd interdigitated electrode (IDE) formed only on the top and bottom PZT sheets (D-IDE), while the other has Ag/Pd IDE on all of the PZT sheets (M-IDE). Cofiring was conducted at 1050 °C for 2 h for PZT laminates with IDEs. The fabricated IDE UPCGs exhibited power densities of 50.4 µW/cm3 for the D-IDE and 820 µW/cm3 for the M-IDE. The UPCG with the M-IDE exhibited a higher performance than that with the D-IDE. Specifically, a significantly enhanced normalized power factor of 670 µW/(g2·cm3) was found at 118 Hz across 100 kΩ.

78 FR 50489 - Petition for Exemption From the Vehicle Theft Prevention Standard; Volkswagen Group of America, Inc.

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-19

...) petition for exemption of the Audi confidential vehicle line in accordance with 49 CFR part 543, Exemption... 2015 Audi vehicle line. The petition requested an exemption from parts- marking requirement pursuant to... the components of the antitheft device for its Audi vehicle line. Volkswagen will install its...

21 CFR 99.305 - Exemption from the requirement to file a supplemental application.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., BIOLOGICS, AND DEVICES FDA Action on Submissions, Requests, and Applications § 99.305 Exemption from the... exemption from the requirement of a supplemental application, FDA shall approve or deny the application. (1) If FDA does not act on the application for an exemption within the 60-day period, the application for...

21 CFR 99.305 - Exemption from the requirement to file a supplemental application.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., BIOLOGICS, AND DEVICES FDA Action on Submissions, Requests, and Applications § 99.305 Exemption from the... exemption from the requirement of a supplemental application, FDA shall approve or deny the application. (1) If FDA does not act on the application for an exemption within the 60-day period, the application for...

21 CFR 99.305 - Exemption from the requirement to file a supplemental application.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., BIOLOGICS, AND DEVICES FDA Action on Submissions, Requests, and Applications § 99.305 Exemption from the... exemption from the requirement of a supplemental application, FDA shall approve or deny the application. (1) If FDA does not act on the application for an exemption within the 60-day period, the application for...

21 CFR 99.305 - Exemption from the requirement to file a supplemental application.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., BIOLOGICS, AND DEVICES FDA Action on Submissions, Requests, and Applications § 99.305 Exemption from the... exemption from the requirement of a supplemental application, FDA shall approve or deny the application. (1) If FDA does not act on the application for an exemption within the 60-day period, the application for...

The study of concentration effects of target hybridization on cervical cancer detection using interdigitated electrodes (IDE)

NASA Astrophysics Data System (ADS)

Noriani, C.; Hashim, U.; Azizah, N.

2016-07-01

Human Papilloma Virus (HPV) is a virus from the Papilloma virus family that affects human skin and the moist membranes that line the body, such as the throat, mouth, feet, fingers, nails, anus and cervix [1]. There are over 100 types, of which 40 can affect the genital area. Most known HPV types cause no symptoms to humans. Some, however, can cause verrucae (warts), while a small number can increase the risk of developing several cancers, such as that of the cervix, penis, vagina, anus and oropharynx (oral part of the pharynx - throat cancer). HPV strand 16 and 18 are well known for causing the advanced of Cervical Cancer (CC). Currently, integrated electrodes (IDEs) are implemented in various sensing devices including surface acoustic wave (SAW) sensors, chemical sensors as well as current MEMS biosensors. IDEs have been optimized for a variety of sensing applications including biosensors sensors, acoustic sensors, and chemical sensors. However, optimization for cancer cell detection has yet to be reported. The output signal strength of IDEs is controlled through careful design of the active area, width, and spacing of the electrode fingers the efficiency of DNA nanochip depends mainly on the sequence of the capture probes and the way they are attached to the support [2]. This strategy presented a simple, rapid and sensitive platform for HPV detection and would become a powerful tool for pathogenic microorganisms screening in clinical diagnosis. The coupling procedure must be quick, covalent, and reproducible.

9 CFR 317.400 - Exemption from nutrition labeling.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Exemption from nutrition labeling. 317... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.400 Exemption from nutrition labeling. Link to an amendment published at 75 FR 82165, Dec. 29, 2010. (a) The...

9 CFR 317.400 - Exemption from nutrition labeling.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Exemption from nutrition labeling. 317... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.400 Exemption from nutrition labeling. Link to an amendment published at 75 FR 82165, Dec. 29, 2010. This amendment...

77 FR 71601 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-03

... in certain circumstances, e.g., recall of the device, the occurrence of unanticipated adverse effects... Annual Reporting Burden \\1\\ Number of Average Activity/21 CFR Section Number of responses per Total annual burden per Total hours respondents respondent responses response Waivers--812.10 1 1 1 1 1 IDE...

21 CFR 822.30 - May I request exemption from the requirement to conduct postmarket surveillance?

Code of Federal Regulations, 2014 CFR

2014-04-01

... conduct postmarket surveillance? 822.30 Section 822.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Waivers and Exemptions § 822.30 May I request exemption from the requirement to conduct postmarket surveillance? You may...

Targeting Insulin-Degrading Enzyme to Treat Type 2 Diabetes Mellitus.

PubMed

Tang, Wei-Jen

2016-01-01

Insulin-degrading enzyme (IDE) selectively degrades peptides, such as insulin, amylin, and amyloid β (Aβ) that form toxic aggregates, to maintain proteostasis. IDE defects are linked to the development of type 2 diabetes mellitus (T2DM) and Alzheimer's disease (AD). Structural and biochemical analyses revealed the molecular basis for IDE-mediated destruction of amyloidogenic peptides and this information has been exploited to develop promising inhibitors of IDE to improve glucose homeostasis. However, the inhibition of IDE can also lead to glucose intolerance. In this review, I focus on recent advances regarding our understanding of the structure and function of IDE and the discovery of IDE inhibitors, as well as challenges in developing IDE-based therapy for human diseases, particularly T2DM. Copyright © 2015 Elsevier Ltd. All rights reserved.

Conformational states and recognition of amyloidogenic peptides of human insulin-degrading enzyme.

PubMed

McCord, Lauren A; Liang, Wenguang G; Dowdell, Evan; Kalas, Vasilios; Hoey, Robert J; Koide, Akiko; Koide, Shohei; Tang, Wei-Jen

2013-08-20

Insulin-degrading enzyme (IDE) selectively degrades the monomer of amyloidogenic peptides and contributes to clearance of amyloid β (Aβ). Thus, IDE retards the progression of Alzheimer's disease. IDE possesses an enclosed catalytic chamber that engulfs and degrades its peptide substrates; however, the molecular mechanism of IDE function, including substrate access to the chamber and recognition, remains elusive. Here, we captured a unique IDE conformation by using a synthetic antibody fragment as a crystallization chaperone. An unexpected displacement of a door subdomain creates an ~18-Å opening to the chamber. This swinging-door mechanism permits the entry of short peptides into the catalytic chamber and disrupts the catalytic site within IDE door subdomain. Given the propensity of amyloidogenic peptides to convert into β-strands for their polymerization into amyloid fibrils, they also use such β-strands to stabilize the disrupted catalytic site resided at IDE door subdomain for their degradation by IDE. Thus, action of the swinging door allows IDE to recognize amyloidogenicity by substrate-induced stabilization of the IDE catalytic cleft. Small angle X-ray scattering (SAXS) analysis revealed that IDE exists as a mixture of closed and open states. These open states, which are distinct from the swinging door state, permit entry of larger substrates (e.g., Aβ, insulin) to the chamber and are preferred in solution. Mutational studies confirmed the critical roles of the door subdomain and hinge loop joining the N- and C-terminal halves of IDE for catalysis. Together, our data provide insights into the conformational changes of IDE that govern the selective destruction of amyloidogenic peptides.

Idebenone-loaded solid lipid nanoparticles for drug delivery to the skin: in vitro evaluation.

PubMed

Montenegro, Lucia; Sinico, Chiara; Castangia, Ines; Carbone, Claudia; Puglisi, Giovanni

2012-09-15

Idebenone (IDE), a synthetic derivative of ubiquinone, shows a potent antioxidant activity that could be beneficial in the treatment of skin oxidative damages. In this work, the feasibility of targeting IDE into the upper layers of the skin by topical application of IDE-loaded solid lipid nanoparticles (SLN) was evaluated. SLN loading different amounts of IDE were prepared by the phase inversion temperature method using cetyl palmitate as solid lipid and three different non-ionic surfactants: ceteth-20, isoceteth-20 and oleth-20. All IDE loaded SLN showed a mean particle size in the range of 30-49 nm and a single peak in size distribution. In vitro permeation/penetration experiments were performed on pig skin using Franz-type diffusion cells. IDE penetration into the different skin layers depended on the type of SLN used while no IDE permeation occurred from all the SLN under investigation. The highest IDE content was found in the epidermis when SLN contained ceteth-20 or isoceteth-20 as surfactant while IDE distribution into the upper skin layers depended on the amount of IDE loaded when oleth-20 was used as surfactant. These results suggest that the SLN tested could be an interesting carrier for IDE targeting to the upper skin layers. Copyright © 2012 Elsevier B.V. All rights reserved.

21 CFR 872.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 872.9 Section 872.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES General...

21 CFR 872.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 872.9 Section 872.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES General...

Catalytic site inhibition of insulin-degrading enzyme by a small molecule induces glucose intolerance in mice

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

Deprez-Poulain, Rebecca; Hennuyer, Nathalie; Bosc, Damien

Insulin-degrading enzyme (IDE) is a protease that cleaves insulin and other bioactive peptides such as amyloid-β. Knockout and genetic studies have linked IDE to Alzheimer’s disease and type-2 diabetes. As the major insulin-degrading protease, IDE is a candidate drug target in diabetes. Here we have used kinetic target-guided synthesis to design the first catalytic site inhibitor of IDE suitable for in vivo studies (BDM44768). Crystallographic and small angle X-ray scattering analyses show that it locks IDE in a closed conformation. Among a panel of metalloproteases, BDM44768 selectively inhibits IDE. Acute treatment of mice with BDM44768 increases insulin signalling and surprisinglymore » impairs glucose tolerance in an IDE-dependent manner. These results confirm that IDE is involved in pathways that modulate short-term glucose homeostasis, but casts doubt on the general usefulness of the inhibition of IDE catalytic activity to treat diabetes.« less

Ensemble cryoEM elucidates the mechanism of insulin capture and degradation by human insulin degrading enzyme

PubMed Central

Bailey, Lucas J; Tan, Yong Zi; Wei, Hui; Wang, Andrew; Farcasanu, Mara; Woods, Virgil A; McCord, Lauren A; Lee, David; Shang, Weifeng; Deprez-Poulain, Rebecca; Deprez, Benoit; Liu, David R; Koide, Akiko; Koide, Shohei; Kossiakoff, Anthony A

2018-01-01

Insulin degrading enzyme (IDE) plays key roles in degrading peptides vital in type two diabetes, Alzheimer's, inflammation, and other human diseases. However, the process through which IDE recognizes peptides that tend to form amyloid fibrils remained unsolved. We used cryoEM to understand both the apo- and insulin-bound dimeric IDE states, revealing that IDE displays a large opening between the homologous ~55 kDa N- and C-terminal halves to allow selective substrate capture based on size and charge complementarity. We also used cryoEM, X-ray crystallography, SAXS, and HDX-MS to elucidate the molecular basis of how amyloidogenic peptides stabilize the disordered IDE catalytic cleft, thereby inducing selective degradation by substrate-assisted catalysis. Furthermore, our insulin-bound IDE structures explain how IDE processively degrades insulin by stochastically cutting either chain without breaking disulfide bonds. Together, our studies provide a mechanism for how IDE selectively degrades amyloidogenic peptides and offers structural insights for developing IDE-based therapies. PMID:29596046

Structure of the streptococcal endopeptidase IdeS, a cysteine proteinase with strict specificity for IgG.

PubMed

Wenig, Katja; Chatwell, Lorenz; von Pawel-Rammingen, Ulrich; Björck, Lars; Huber, Robert; Sondermann, Peter

2004-12-14

Pathogenic bacteria have developed complex and diverse virulence mechanisms that weaken or disable the host immune defense system. IdeS (IgG-degrading enzyme of Streptococcus pyogenes) is a secreted cysteine endopeptidase from the human pathogen S. pyogenes with an extraordinarily high degree of substrate specificity, catalyzing a single proteolytic cleavage at the lower hinge of human IgG. This proteolytic degradation promotes inhibition of opsonophagocytosis and interferes with the killing of group A Streptococcus. We have determined the crystal structure of the catalytically inactive mutant IdeS-C94S by x-ray crystallography at 1.9-A resolution. Despite negligible sequence homology to known proteinases, the core of the structure resembles the canonical papain fold although with major insertions and a distinct substrate-binding site. Therefore IdeS belongs to a unique family within the CA clan of cysteine proteinases. Based on analogy with inhibitor complexes of papain-like proteinases, we propose a model for substrate binding by IdeS.

Catalytic site inhibition of insulin-degrading enzyme by a small molecule induces glucose intolerance in mice

DOE PAGES

Deprez-Poulain, Rebecca; Hennuyer, Nathalie; Bosc, Damien; ...

2015-09-23

Insulin-degrading enzyme (IDE) is a protease that cleaves insulin and other bioactive peptides such as amyloid-β. Knockout and genetic studies have linked IDE to Alzheimer’s disease and type-2 diabetes. As the major insulin-degrading protease, IDE is a candidate drug target in diabetes. Here we have used kinetic target-guided synthesis to design the first catalytic site inhibitor of IDE suitable for in vivo studies (BDM44768). Crystallographic and small angle X-ray scattering analyses show that it locks IDE in a closed conformation. Among a panel of metalloproteases, BDM44768 selectively inhibits IDE. Acute treatment of mice with BDM44768 increases insulin signalling and surprisinglymore » impairs glucose tolerance in an IDE-dependent manner. These results confirm that IDE is involved in pathways that modulate short-term glucose homeostasis, but casts doubt on the general usefulness of the inhibition of IDE catalytic activity to treat diabetes.« less

Nanostructure Engineered Chemical Sensors for Hazardous Gas and Vapor Detection

NASA Technical Reports Server (NTRS)

Li, Jing; Lu, Yijiang

2005-01-01

A nanosensor technology has been developed using nanostructures, such as single walled carbon nanotubes (SWNTs) and metal oxides nanowires or nanobelts, on a pair of interdigitated electrodes (IDE) processed with a silicon based microfabrication and micromachining technique. The IDE fingers were fabricated using thin film metallization techniques. Both in-situ growth of nanostructure materials and casting of the nanostructure dispersions were used to make chemical sensing devices. These sensors have been exposed to hazardous gases and vapors, such as acetone, benzene, chlorine, and ammonia in the concentration range of ppm to ppb at room temperature. The electronic molecular sensing in our sensor platform can be understood by electron modulation between the nanostructure engineered device and gas molecules. As a result of the electron modulation, the conductance of nanodevice will change. Due to the large surface area, low surface energy barrier and high thermal and mechanical stability, nanostructured chemical sensors potentially can offer higher sensitivity, lower power consumption and better robustness than the state-of-the-art systems, which make them more attractive for defense and space applications. Combined with MEMS technology, light weight and compact size sensors can be made in wafer scale with low cost.

Molecular Basis for the Recognition and Cleavages of IGF-II, TGF-[alpha], and Amylin by Human Insulin-Degrading Enzyme

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

Guo, Qing; Manolopoulou, Marika; Bian, Yao

2010-02-11

Insulin-degrading enzyme (IDE) is involved in the clearance of many bioactive peptide substrates, including insulin and amyloid-{beta}, peptides vital to the development of diabetes and Alzheimer's disease, respectively. IDE can also rapidly degrade hormones that are held together by intramolecular disulfide bond(s) without their reduction. Furthermore, IDE exhibits a remarkable ability to preferentially degrade structurally similar peptides such as the selective degradation of insulin-like growth factor (IGF)-II and transforming growth factor-{alpha} (TGF-{alpha}) over IGF-I and epidermal growth factor, respectively. Here, we used high-accuracy mass spectrometry to identify the cleavage sites of human IGF-II, TGF-{alpha}, amylin, reduced amylin, and amyloid-{beta} bymore » human IDE. We also determined the structures of human IDE-IGF-II and IDE-TGF-{alpha} at 2.3 {angstrom} and IDE-amylin at 2.9 {angstrom}. We found that IDE cleaves its substrates at multiple sites in a biased stochastic manner. Furthermore, the presence of a disulfide bond in amylin allows IDE to cut at an additional site in the middle of the peptide (amino acids 18-19). Our amylin-bound IDE structure offers insight into how the structural constraint from a disulfide bond in amylin can alter IDE cleavage sites. Together with NMR structures of amylin and the IGF and epidermal growth factor families, our work also reveals the structural basis of how the high dipole moment of substrates complements the charge distribution of the IDE catalytic chamber for the substrate selectivity. In addition, we show how the ability of substrates to properly anchor their N-terminus to the exosite of IDE and undergo a conformational switch upon binding to the catalytic chamber of IDE can also contribute to the selective degradation of structurally related growth factors.« less

21 CFR 872.3060 - Noble metal alloy.

Code of Federal Regulations, 2014 CFR

2014-04-01

... DEVICES DENTAL DEVICES Prosthetic Devices § 872.3060 Noble metal alloy. (a) Identification. A noble metal... “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the...

21 CFR 862.1795 - Vanilmandelic acid test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... certain hypertensive conditions. (b) Classification. Class I (general controls). The device is exempt from...

Graphene electrodes for lithium-niobate electro-optic devices.

PubMed

Chang, Zeshan; Jin, Wei; Chiang, Kin Seng

2018-04-15

We propose and demonstrate the use of graphene electrodes for lithium-niobate electro-optic (EO) devices to exempt the need of incorporating a buffer layer between the waveguide and the electrodes. Using graphene electrodes, our experimental mode converter, based on an EO-generated long-period grating in a LiNbO 3 waveguide, shows a reduction in the half-π voltage by almost three times, compared with the conventional electrode design using metal. With the buffer layer exempted, the device fabrication process is also significantly simplified. The use of graphene electrodes is an effective approach to enhancing the efficiency of EO devices and, at the same time, reducing their fabrication cost.

49 CFR 385.815 - Exemption for AOBRD users.

Code of Federal Regulations, 2010 CFR

2010-10-01

... the AOBRDs currently in its CMVs or install new devices compliance with § 395.16 of this chapter. (d... to ongoing FMCSA oversight. (e) The exemption granted under this section shall not apply to CMVs...

49 CFR 385.815 - Exemption for AOBRD users.

Code of Federal Regulations, 2011 CFR

2011-10-01

... the AOBRDs currently in its CMVs or install new devices compliance with § 395.16 of this chapter. (d... to ongoing FMCSA oversight. (e) The exemption granted under this section shall not apply to CMVs...

21 CFR 862.1490 - Lysozyme (muramidase) test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... monocytic leukemia and kidney disease. (b) Classification. Class I (general controls). The device is exempt...

21 CFR 862.1500 - Malic dehydrogenase test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... marrow) leukemia. (b) Classification. Class I (general controls). The device is exempt from the premarket...

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

Manolopoulou, Marika; Guo, Qing; Malito, Enrico

Insulin is a hormone vital for glucose homeostasis, and insulin-degrading enzyme (IDE) plays a key role in its clearance. IDE exhibits a remarkable specificity to degrade insulin without breaking the disulfide bonds that hold the insulin A and B chains together. Using Fourier transform ion cyclotron resonance (FTICR) mass spectrometry to obtain high mass accuracy, and electron capture dissociation (ECD) to selectively break the disulfide bonds in gas phase fragmentation, we determined the cleavage sites and composition of human insulin fragments generated by human IDE. Our time-dependent analysis of IDE-digested insulin fragments reveals that IDE is highly processive in itsmore » initial cleavage at the middle of both the insulin A and B chains. This ensures that IDE effectively splits insulin into inactive N- and C-terminal halves without breaking the disulfide bonds. To understand the molecular basis of the recognition and unfolding of insulin by IDE, we determined a 2.6-A resolution insulin-bound IDE structure. Our structure reveals that IDE forms an enclosed catalytic chamber that completely engulfs and intimately interacts with a partially unfolded insulin molecule. This structure also highlights how the unique size, shape, charge distribution, and exosite of the IDE catalytic chamber contribute to its high affinity ( approximately 100 nm) for insulin. In addition, this structure shows how IDE utilizes the interaction of its exosite with the N terminus of the insulin A chain as well as other properties of the catalytic chamber to guide the unfolding of insulin and allowing for the processive cleavages.« less

21 CFR 862.1380 - Hydroxybutyric dehydrogenase test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

21 CFR 862.1330 - Globulin test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... other disorders of blood globulins. (b) Classification. Class I (general controls). The device is exempt...

21 CFR 862.1470 - Lipid (total) test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862.... (b) Classification. Class I (general controls). The device is exempt from the premarket notification...

21 CFR 862.1805 - Vitamin A test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862.... (b) Classification. Class I (general controls). The device is exempt from the premarket notification...

21 CFR 862.1605 - Pregnanediol test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862...) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in...

21 CFR 862.1395 - 17-Hydroxyprogesterone test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... adrenal glands or the ovaries. (b) Classification. Class I (general controls). The device is exempt from...

Impedance Characterization of the Degradation of Insulating Layer Patterned on Interdigitated Microelectrode.

PubMed

Lee, Gihyun; Kim, Sohee; Cho, Sungbo

2015-10-01

Life-time and functionality of planar microelectrode-based devices are determined by not only the corrosion-resistance of the electrode, but also the durability of the insulation layer coated on the transmission lines. Degradation of the insulating layer exposed to a humid environment or solution may cause leakage current or signal loss, and a decrease in measurement sensitivity. In this study, degradation of SU-8, an epoxy-based negative photoresist and insulating material, patterned on Au interdigitated microelectrode (IDE) for long-term (>30 days) immersion in an electrolyte at 37 °C was investigated by electrical impedance spectroscopy and theoretical equivalent circuit modeling. From the experiment and simulation results, it was found that the degradation level of the insulating layer of the IDE electrode can be characterized by monitoring the resistance of the insulating layer among the circuit parameters of the designed equivalent circuit modeling.

21 CFR 862.1590 - Porphobilinogen test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

21 CFR 862.1790 - Uroporphyrin test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

21 CFR 862.1595 - Porphyrins test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

21 CFR 862.1325 - Gastrin test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862...-secreting tumor of the pancreas). (b) Classification. Class I (general controls). The device is exempt from...

21 CFR 862.1620 - Progesterone test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

An Assessment of a Beowulf System for a Wide Class of Analysis and Design Software

NASA Technical Reports Server (NTRS)

Katz, D. S.; Cwik, T.; Kwan, B. H.; Lou, J. Z.; Springer, P. L.; Sterling, T. L.; Wang, P.

1997-01-01

A typical Beowulf system, such as the machine at the Jet Propulsion Laboratory (JPL), may comprise 16 nodes interconnected by 100 base T Fast Ethernet. Each node may include a single Inter Pentium Pro 200 MHz microprocessor, 128 MBytes of DRAM, 2.5 GBytes of IDE disk, and PCI bus backplane, and an assortment of other devices.

21 CFR 886.3100 - Ophthalmic tantalum clip.

Code of Federal Regulations, 2010 CFR

2010-04-01

... blood vessels in the eye. (b) Classification. Class II (special controls). The device is exempt from the...) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3100 Ophthalmic tantalum clip. (a) Identification. An ophthalmic tantalum clip is a malleable metallic device intended to be implanted permanently...

21 CFR 886.1380 - Diagnostic condensing lens.

Code of Federal Regulations, 2010 CFR

2010-04-01

... light from the fundus of the eye. (b) Classification. Class I (general controls). The device is exempt...) 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...

77 FR 32644 - Medical Devices; Exemption From Premarket Notification: Wheelchair Elevator

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-01

... elevator devices commonly known as inclined platform lifts and vertical platform lifts. These devices are... inclined platform lifts and vertical platform lifts), classified under 21 CFR 890.3930. IV. Comments...

Expression of metalloprotease insulin-degrading enzyme (insulysin) in normal and malignant human tissues

PubMed Central

Yfanti, Christina; Mengele, Karin; Gkazepis, Apostolos; Weirich, Gregor; Giersig, Cecylia; Kuo, Wen-Liang; Tang, Wei-Jen; Rosner, Marsha; Schmitt, Manfred

2013-01-01

Background Insulin-degrading enzyme (IDE, insulysin, insulinase; EC 3.4.22.11), a thiol metalloendopeptidase, is involved in intracellular degradation of insulin, thereby inhibiting its translocation and accumulation to the nucleus. Recently, protein expression of IDE has been demonstrated in the epithelial ducts of normal breast and in breast cancer tissue (Radulescu et al., Int J Oncol 30:73; 2007). Materials and Methods Utilizing four different antibodies generated against different epitopes of the IDE molecule, we performed western blot analysis and immunohistochemical staining on several normal human tissues, on a plethora of tumor cell lines of different tissue origin, and on malignant breast and ovarian tissue. Results Applying the four IDE-directed antibodies, we demonstrate IDE expression at the protein level, both by means of immunoblotting and immunocytochemistry, in all of the tumor cell lines analyzed. Besides, IDE protein expression was found in normal tissues of the kidney, liver, lung, brain, breast and skeletal muscle, as well as in breast and ovarian cancer tissues. Immunohistochemical visualization of IDE indicated cytoplasmic localization of IDE in all of the cell lines and tissues assessed. Conclusions We performed for the first time a wide-ranging survey on IDE protein expression in normal and malignant tissues and cells and thus extend knowledge about cellular and tissue distribution of IDE, an enzyme which so far has mainly been studied in connection with Alzheimer’s disease and diabetes but not in cancer. PMID:18813847

Proteolysis of mature HIV-1 p6 Gag protein by the insulin-degrading enzyme (IDE) regulates virus replication in an Env-dependent manner.

PubMed

Hahn, Friedrich; Schmalen, Adrian; Setz, Christian; Friedrich, Melanie; Schlößer, Stefan; Kölle, Julia; Spranger, Robert; Rauch, Pia; Fraedrich, Kirsten; Reif, Tatjana; Karius-Fischer, Julia; Balasubramanyam, Ashok; Henklein, Petra; Fossen, Torgils; Schubert, Ulrich

2017-01-01

There is a significantly higher risk for type II diabetes in HIV-1 carriers, albeit the molecular mechanism for this HIV-related pathology remains enigmatic. The 52 amino acid HIV-1 p6 Gag protein is synthesized as the C-terminal part of the Gag polyprotein Pr55. In this context, p6 promotes virus release by its two late (L-) domains, and facilitates the incorporation of the viral accessory protein Vpr. However, the function of p6 in its mature form, after proteolytic release from Gag, has not been investigated yet. We found that the mature p6 represents the first known viral substrate of the ubiquitously expressed cytosolic metalloendopeptidase insulin-degrading enzyme (IDE). IDE is sufficient and required for degradation of p6, and p6 is approximately 100-fold more efficiently degraded by IDE than its eponymous substrate insulin. This observation appears to be specific for HIV-1, as p6 proteins from HIV-2 and simian immunodeficiency virus, as well as the 51 amino acid p9 from equine infectious anaemia virus were insensitive to IDE degradation. The amount of virus-associated p6, as well as the efficiency of release and maturation of progeny viruses does not depend on the presence of IDE in the host cells, as it was shown by CRISPR/Cas9 edited IDE KO cells. However, HIV-1 mutants harboring IDE-insensitive p6 variants exhibit reduced virus replication capacity, a phenomenon that seems to depend on the presence of an X4-tropic Env. Furthermore, competing for IDE by exogenous insulin or inhibiting IDE by the highly specific inhibitor 6bK, also reduced virus replication. This effect could be specifically attributed to IDE since replication of HIV-1 variants coding for an IDE-insensitive p6 were inert towards IDE-inhibition. Our cumulative data support a model in which removal of p6 during viral entry is important for virus replication, at least in the case of X4 tropic HIV-1.

21 CFR 872.6570 - Impression tube.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DEVICES DENTAL DEVICES Miscellaneous Devices § 872.6570 Impression tube. (a) Identification. An impression tube is a device consisting of a hollow copper tube intended to take an impression of a single tooth...) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in...

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...

77 FR 2555 - Guidance for Industry: Preparation of Investigational Device Exemptions and Investigational New...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-18

... editorial changes were made to improve clarity. Some terminology was changed to harmonize terminology within.../MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm , or http://www.regulations.gov...

Integration of Wireless Sensor Networks into a Commercial Off-the-Shelf (COTS) Multimedia Network

DTIC Science & Technology

2008-12-01

IDE) which supports JAVA ME or in a basic text editor. The simplest IDE to use is the Netbeans IDE, which is supported by Sun 34 Microsystems...discussion,” https://www.sunspotworld.com/forums, November 2008. [28] Netbeans.org, “ Netbeans IDE version 6.5 download,” http://www.netbeans.org

27 CFR 479.33 - Special exemption.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2012-04-01 2010-04-01 true Special exemption. 479.33 Section 479.33 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES, AND CERTAIN...

27 CFR 479.33 - Special exemption.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2014-04-01 2014-04-01 false Special exemption. 479.33 Section 479.33 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES, AND CERTAIN...

27 CFR 479.33 - Special exemption.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2010-04-01 2010-04-01 false Special exemption. 479.33 Section 479.33 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES, AND CERTAIN...

27 CFR 479.33 - Special exemption.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2011-04-01 2010-04-01 true Special exemption. 479.33 Section 479.33 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES, AND CERTAIN...

27 CFR 479.33 - Special exemption.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2013-04-01 2013-04-01 false Special exemption. 479.33 Section 479.33 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES, AND CERTAIN...

A two-in-one Faraday rotator mirror exempt of active optical alignment.

PubMed

Wan, Qiong; Wan, Zhujun; Liu, Hai; Liu, Deming

2014-02-10

A two-in-one Faraday rotator mirror was presented, which functions as two independent Faraday rotation mirrors with a single device. With the introduction of a reflection lens as substitution of the mirror in traditional structure, this device is characterized by exemption of active optical alignment for the designers and manufacturers of Faraday rotator mirrors. A sample was fabricated by passive mechanical assembly. The insertion loss was measured as 0.46 dB/0.50 dB for the two independent ports, respectively.

21 CFR 886.1430 - Ophthalmic contact lens radius measuring device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic contact lens radius measuring device... lens radius measuring device. (a) Identification. An ophthalmic contact lens radius measuring device is... lens. (b) Classification. Class I (general controls). The device is exempt from the premarket...

21 CFR 886.4300 - Intraocular lens guide.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4300 Intraocular lens guide. (a) Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct... lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this...

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...

Expression of metalloprotease insulin-degrading enzyme insulysin in normal and malignant human tissues.

PubMed

Yfanti, Christina; Mengele, Karin; Gkazepis, Apostolos; Weirich, Gregor; Giersig, Cecylia; Kuo, Wen-Liang; Tang, Wei-Jen; Rosner, Marsha; Schmitt, Manfred

2008-10-01

Insulin-degrading enzyme (IDE, insulysin, insulinase; EC 3.4.22.11), a thiol metalloendopeptidase, is involved in intracellular degradation of insulin, thereby inhibiting its translocation and accumulation to the nucleus. Recently, protein expression of IDE has been demonstrated in the epithelial ducts of normal breast and breast cancer tissue. Utilizing four different antibodies generated against different epitopes of the IDE molecule, we performed Western blot analysis and immunohistochemical staining on several normal human tissues, on a plethora of tumor cell lines of different tissue origin, and on malignant breast and ovarian tissue. Applying the four IDE-directed antibodies, we demonstrated IDE expression at the protein level, by means of immunoblotting and immunocytochemistry, in each of the tumor cell lines analyzed. Insulin-degrading enzyme protein expression was found in normal tissues of the kidney, liver, lung, brain, breast and skeletal muscle, as well as in breast and ovarian cancer tissues. Immunohistochemical visualization of IDE indicated cytoplasmic localization of IDE in each of the cell lines and tissues assessed. In conclusion, we performed for the first time a wide-ranging survey on IDE protein expression in normal and malignant tissues and cells thus extending our knowledge on the cellular and tissue distribution of IDE, an enzyme which to date has mainly been studied in connection with Alzheimer's disease and diabetes but not in cancer.

Notch signaling proteins HES-1 and Hey-1 bind to insulin degrading enzyme (IDE) proximal promoter and repress its transcription and activity: Implications for cellular Aβ metabolism

PubMed Central

Leal, María C.; Surace, Ezequiel I.; Holgado, María P.; Ferrari, Carina C.; Tarelli, Rodolfo; Pitossi, Fernando; Wisniewski, Thomas; Castaño, Eduardo M.; Morelli, Laura

2012-01-01

Cerebral amyloid β (Aβ) accumulation is pathogenically associated with sporadic Alzheimer’s disease (SAD). BACE-1 is involved in Aβ generation while insulin-degrading enzyme (IDE) partakes in Aβ proteolytic clearance. Vulnerable regions in AD brains show increased BACE-1 protein levels and enzymatic activity while the opposite occurs with IDE. Another common feature in SAD brains is Notch1 overexpression. Here we demonstrate an increase in mRNA levels of Hey-1, a Notch target gene, and a decrease of IDE transcripts in the hippocampus of SAD brains as compared to controls. Transient transfection of Notch intracellular domain (NICD) in N2aSW cells, mouse neuroblastoma cells (N2a) stably expressing human amyloid precursor protein (APP) Swedish mutation, reduce IDE mRNA levels, promoting extracellular Aβ accumulation. Also, NICD, HES-1 and Hey-1 overexpression result in decreased IDE proximal promoter activity. This effect was mediated by 2 functional sites located at −379/−372 and −310 −303 from the first translation start site in the −575/−19 (556 bp) fragment of IDE proximal promoter. By site-directed mutagenesis of the IDE promoter region we reverted the inhibitory effect mediated by NICD transfection suggesting that these sites are indeed responsible for the Notch-mediated inhibition of the IDE gene expression. Intracranial injection of the Notch ligand JAG-1 in Tg2576 mice, expressing the Swedish mutation in human APP, induced overexpression of HES-1 and Hey-1 and reduction of IDE mRNA levels, respectively. Our results support our theory that a Notch-dependent IDE transcriptional modulation may impact on Aβ metabolism providing a functional link between Notch signaling and the amyloidogenic pathway in SAD. PMID:22036964

Dual Exosite-binding Inhibitors of Insulin-degrading Enzyme Challenge Its Role as the Primary Mediator of Insulin Clearance in Vivo*

PubMed Central

Durham, Timothy B.; Toth, James L.; Klimkowski, Valentine J.; Cao, Julia X. C.; Siesky, Angela M.; Alexander-Chacko, Jesline; Wu, Ginger Y.; Dixon, Jeffrey T.; McGee, James E.; Wang, Yong; Guo, Sherry Y.; Cavitt, Rachel Nicole; Schindler, John; Thibodeaux, Stefan J.; Calvert, Nathan A.; Coghlan, Michael J.; Sindelar, Dana K.; Christe, Michael; Kiselyov, Vladislav V.; Michael, M. Dodson; Sloop, Kyle W.

2015-01-01

Insulin-degrading enzyme (IDE, insulysin) is the best characterized catabolic enzyme implicated in proteolysis of insulin. Recently, a peptide inhibitor of IDE has been shown to affect levels of insulin, amylin, and glucagon in vivo. However, IDE−/− mice display variable phenotypes relating to fasting plasma insulin levels, glucose tolerance, and insulin sensitivity depending on the cohort and age of animals. Here, we interrogated the importance of IDE-mediated catabolism on insulin clearance in vivo. Using a structure-based design, we linked two newly identified ligands binding at unique IDE exosites together to construct a potent series of novel inhibitors. These compounds do not interact with the catalytic zinc of the protease. Because one of these inhibitors (NTE-1) was determined to have pharmacokinetic properties sufficient to sustain plasma levels >50 times its IDE IC50 value, studies in rodents were conducted. In oral glucose tolerance tests with diet-induced obese mice, NTE-1 treatment improved the glucose excursion. Yet in insulin tolerance tests and euglycemic clamp experiments, NTE-1 did not enhance insulin action or increase plasma insulin levels. Importantly, IDE inhibition with NTE-1 did result in elevated plasma amylin levels, suggesting the in vivo role of IDE action on amylin may be more significant than an effect on insulin. Furthermore, using the inhibitors described in this report, we demonstrate that in HEK cells IDE has little impact on insulin clearance. In total, evidence from our studies supports a minimal role for IDE in insulin metabolism in vivo and suggests IDE may be more important in helping regulate amylin clearance. PMID:26085101

21 CFR 886.1810 - Tangent screen (campimeter).

Code of Federal Regulations, 2013 CFR

2013-04-01

...) Identification. A tangent screen (campimeter) is an AC-powered or battery-powered device that is a large square... a patient's visual field. This generic type of device includes projection tangent screens, target... (general controls). The AC-powered device and the battery-powered device are exempt from the premarket...

21 CFR 886.1810 - Tangent screen (campimeter).

Code of Federal Regulations, 2012 CFR

2012-04-01

...) Identification. A tangent screen (campimeter) is an AC-powered or battery-powered device that is a large square... a patient's visual field. This generic type of device includes projection tangent screens, target... (general controls). The AC-powered device and the battery-powered device are exempt from the premarket...

21 CFR 886.1810 - Tangent screen (campimeter).

Code of Federal Regulations, 2011 CFR

2011-04-01

...) Identification. A tangent screen (campimeter) is an AC-powered or battery-powered device that is a large square... a patient's visual field. This generic type of device includes projection tangent screens, target... (general controls). The AC-powered device and the battery-powered device are exempt from the premarket...

21 CFR 886.1810 - Tangent screen (campimeter).

Code of Federal Regulations, 2014 CFR

2014-04-01

...) Identification. A tangent screen (campimeter) is an AC-powered or battery-powered device that is a large square... a patient's visual field. This generic type of device includes projection tangent screens, target... (general controls). The AC-powered device and the battery-powered device are exempt from the premarket...

21 CFR 880.6890 - General purpose disinfectants.

Code of Federal Regulations, 2010 CFR

2010-04-01

... prior to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin. (b) Classification. Class I (general controls). The device is exempt...

Somatostatin modulates insulin-degrading-enzyme metabolism: implications for the regulation of microglia activity in AD.

PubMed

Tundo, Grazia; Ciaccio, Chiara; Sbardella, Diego; Boraso, Mariaserena; Viviani, Barbara; Coletta, Massimiliano; Marini, Stefano

2012-01-01

The deposition of β-amyloid (Aβ) into senile plaques and the impairment of somatostatin-mediated neurotransmission are key pathological events in the onset of Alzheimer's disease (AD). Insulin-degrading-enzyme (IDE) is one of the main extracellular protease targeting Aβ, and thus it represents an interesting pharmacological target for AD therapy. We show that the active form of somatostatin-14 regulates IDE activity by affecting its expression and secretion in microglia cells. A similar effect can also be observed when adding octreotide. Following a previous observation where somatostatin directly interacts with IDE, here we demonstrate that somatostatin regulates Aβ catabolism by modulating IDE proteolytic activity in IDE gene-silencing experiments. As a whole, these data indicate the relevant role played by somatostatin and, potentially, by analogue octreotide, in preventing Aβ accumulation by partially restoring IDE activity.

Association and haplotype analysis of the insulin-degrading enzyme (IDE) gene, a strong positional and biological candidate for type 2 diabetes susceptibility.

PubMed

Groves, Christopher J; Wiltshire, Steven; Smedley, Damian; Owen, Katherine R; Frayling, Timothy M; Walker, Mark; Hitman, Graham A; Levy, Jonathan C; O'Rahilly, Stephen; Menzel, Stephan; Hattersley, Andrew T; McCarthy, Mark I

2003-05-01

The gene for insulin-degrading enzyme (IDE) represents a strong positional and biological candidate for type 2 diabetes susceptibility. IDE maps to chromosome 10q23.3, a region linked to diabetes in several populations; the rat homolog has been directly implicated in diabetes susceptibility; and known functions of IDE support an important role in glucose homeostasis. We sought evidence for association between IDE variation and diabetes by mutation screening, defining local haplotype structure, and genotyping variants delineating common haplotypic diversity. An initial case-control analysis (628 diabetic probands from multiplex sibships and 604 control subjects) found no haplotypic associations, although one variant (IDE2, -179T-->C) showed modest association with diabetes (odds ratio [OR]1.25, P = 0.03). Linkage partitioning analyses failed to support this association, but provided borderline evidence for a different variant (IDE10, IVS20-405A-->G) (P = 0.06). Neither variant was associated with diabetes when replication was sought in 377 early onset diabetic subjects and 825 control subjects, though combined analysis of all typed cohorts indicated a nominally significant effect at IDE2 (OR 1.21 [1.04-1.40], P = 0.013). In the absence of convincing support for this association from linkage partitioning or analyses of continuous measures of glycemia, we conclude that analysis of over 2,400 samples provides no compelling evidence that variation in IDE contributes to diabetes susceptibility in humans.

Anti-diabetic activity of insulin-degrading enzyme inhibitors mediated by multiple hormones

PubMed Central

Maianti, Juan Pablo; McFedries, Amanda; Foda, Zachariah H.; Kleiner, Ralph E.; Du, Xiu Quan; Leissring, Malcolm A.; Tang, Wei-Jen; Charron, Maureen J.; Seeliger, Markus A.; Saghatelian, Alan; Liu, David R.

2014-01-01

Despite decades of speculation that inhibiting endogenous insulin degradation might treat type-2 diabetes1, 2, and the identification of IDE (insulin-degrading enzyme) as a diabetes susceptibility gene3, 4, the relationship between the activity of the zinc metalloprotein IDE and glucose homeostasis remains unclear. Although Ide−/− mice have elevated insulin levels, they exhibit impaired, rather than improved, glucose tolerance that may arise from compensatory insulin signalling dysfunction5, 6. IDE inhibitors that are active in vivo are therefore needed to elucidate IDE’s physiological roles and to determine its potential to serve as a target for the treatment of diabetes. Here we report the discovery of a physiologically active IDE inhibitor identified from a DNA-templated macrocycle library. An X-ray structure of the macrocycle bound to IDE reveals that it engages a binding pocket away from the catalytic site, which explains its remarkable selectivity. Treatment of lean and obese mice with this inhibitor shows that IDE regulates the abundance and signalling of glucagon and amylin, in addition to that of insulin. Under physiological conditions that augment insulin and amylin levels, such as oral glucose administration, acute IDE inhibition leads to substantially improved glucose tolerance and slower gastric emptying. These findings demonstrate the feasibility of modulating IDE activity as a new therapeutic strategy to treat type-2 diabetes and expand our understanding of the roles of IDE in glucose and hormone regulation. PMID:24847884

21 CFR 807.25 - Information required for device establishment registration and device listing.

Code of Federal Regulations, 2013 CFR

2013-04-01

... other provision of the Federal Food, Drug, and Cosmetic Act. (g) Device listing information must be... establishment under the ownership and control of the owner or operator where the device is manufactured..., Drug, and Cosmetic Act, which includes devices that are not exempt from premarket notification and...

21 CFR 807.25 - Information required for device establishment registration and device listing.

Code of Federal Regulations, 2014 CFR

2014-04-01

... other provision of the Federal Food, Drug, and Cosmetic Act. (g) Device listing information must be... establishment under the ownership and control of the owner or operator where the device is manufactured..., Drug, and Cosmetic Act, which includes devices that are not exempt from premarket notification and...

Study of concentration of HPV DNA probe immobilization for cervical cancer detection based IDE biosensor

NASA Astrophysics Data System (ADS)

Roshila, M. L.; Hashim, U.; Azizah, N.

2016-07-01

This paper mainly illustrates regarding the detection process of Human Papillomavirus (HPV) DNA probe. HPV is the most common virus that infected to human by a sexually transmitted virus. The most common high-risk HPV are 16 and 18. Interdigitated electrode (IDE) device used as based of Titanium Dioxide (TiO2) acts as inorganic surface, where by using APTES as a linker between inorganic surface and organic surface. A strategy of rapid and sensitive for the HPV detection was proposed by integrating simple DNA extraction with a gene of DNA. The extraction of the gene of DNA will make an efficiency of the detection process. It will depend on the sequence of the capture probes and the way to support their attached. The fabrication, surface modification, immobilization and hybridization processes are characterized by current voltage (I-V) measurement by using KEITHLEY 6487. This strategy will perform a good sensitivity of HPV detection.

Streptococcus pyogenes Infection and the Human Proteome with a Special Focus on the Immunoglobulin G-cleaving Enzyme IdeS.

PubMed

Karlsson, Christofer A Q; Järnum, Sofia; Winstedt, Lena; Kjellman, Christian; Björck, Lars; Linder, Adam; Malmström, Johan A

2018-06-01

Infectious diseases are characterized by a complex interplay between host and pathogen, but how these interactions impact the host proteome is unclear. Here we applied a combined mass spectrometry-based proteomics strategy to investigate how the human proteome is transiently modified by the pathogen Streptococcus pyogenes , with a particular focus on bacterial cleavage of IgG in vivo In invasive diseases, S. pyogenes evokes a massive host response in blood, whereas superficial diseases are characterized by a local leakage of several blood plasma proteins at the site of infection including IgG. S. pyogenes produces IdeS, a protease cleaving IgG in the lower hinge region and we find highly effective IdeS-cleavage of IgG in samples from local IgG poor microenvironments. The results show that IdeS contributes to the adaptation of S. pyogenes to its normal ecological niches. Additionally, the work identifies novel clinical opportunities for in vivo pathogen detection. © 2018 by The American Society for Biochemistry and Molecular Biology, Inc.

Weak independent association signals between IDE polymorphisms, Alzheimer's disease and cognitive measures.

PubMed

Mueller, Jakob C; Riemenschneider, Matthias; Schoepfer-Wendels, Andreas; Gohlke, Henning; Konta, Lidija; Friedrich, Patricia; Illig, Thomas; Laws, Simon M; Förstl, Hans; Kurz, Alexander

2007-05-01

Functional and genetic studies suggest that insulin-degrading enzyme (IDE) may be a strong functional and positional candidate. As there is a lack of consensus in regards to the level and location of IDE association signals we aimed to clarify these discrepancies through genotyping 28 SNPs in a large case-control collective together with quantitative measures of cognitive ability (MMSE). Four SNPs (rs11187007, rs2149632_ide12, rs11187033, rs11187040) were found to be associated with AD (nominal p<0.01). Tests with MMSE scores adjusted for disease duration identified associations, with the most significant result for rs1999763 (nominal p=0.008). Similarly, different reconstructed IDE haplotypes were associated with AD and higher MMSE scores. The association signals are only borderline significant after adjustment for multiple testing, but add further evidence to previous published results on the association between IDE and AD or MMSE. A subgroup analysis indicated more prominent associations with AD in younger, and with MMSE in older patients. There may be two independent effects mediated by IDE variants, risk for AD and modification of disease progression.

78 FR 19363 - Petition for Exemption From the Vehicle Theft Prevention Standard; Honda

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-29

... immobilizer device occurs automatically when the vehicle is started without any further action by the driver... From the Vehicle Theft Prevention Standard; Honda AGENCY: National Highway Traffic Safety... Honda Civic vehicle line in accordance with 49 CFR part 543, Exemption from the Theft Prevention...

21 CFR 880.5300 - Medical absorbent fiber.

Code of Federal Regulations, 2012 CFR

2012-04-01

...'s body surface. Absorbent fibers intended solely for cosmetic purposes are not included in this generic device category. (b) Classification. Class I (general controls). The device is exempt from the...

21 CFR 880.5300 - Medical absorbent fiber.

Code of Federal Regulations, 2013 CFR

2013-04-01

...'s body surface. Absorbent fibers intended solely for cosmetic purposes are not included in this generic device category. (b) Classification. Class I (general controls). The device is exempt from the...

21 CFR 880.5300 - Medical absorbent fiber.

Code of Federal Regulations, 2014 CFR

2014-04-01

...'s body surface. Absorbent fibers intended solely for cosmetic purposes are not included in this generic device category. (b) Classification. Class I (general controls). The device is exempt from the...

21 CFR 874.4100 - Epistaxis balloon.

Code of Federal Regulations, 2010 CFR

2010-04-01

.... An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal... (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

Somatostatin Modulates Insulin-Degrading-Enzyme Metabolism: Implications for the Regulation of Microglia Activity in AD

PubMed Central

Tundo, Grazia; Ciaccio, Chiara; Sbardella, Diego; Boraso, Mariaserena; Viviani, Barbara; Coletta, Massimiliano; Marini, Stefano

2012-01-01

The deposition of β-amyloid (Aβ) into senile plaques and the impairment of somatostatin-mediated neurotransmission are key pathological events in the onset of Alzheimer's disease (AD). Insulin-degrading-enzyme (IDE) is one of the main extracellular protease targeting Aβ, and thus it represents an interesting pharmacological target for AD therapy. We show that the active form of somatostatin-14 regulates IDE activity by affecting its expression and secretion in microglia cells. A similar effect can also be observed when adding octreotide. Following a previous observation where somatostatin directly interacts with IDE, here we demonstrate that somatostatin regulates Aβ catabolism by modulating IDE proteolytic activity in IDE gene-silencing experiments. As a whole, these data indicate the relevant role played by somatostatin and, potentially, by analogue octreotide, in preventing Aβ accumulation by partially restoring IDE activity. PMID:22509294

21 CFR 868.6175 - Cardiopulmonary emergency cart.

Code of Federal Regulations, 2011 CFR

2011-04-01

... cardiopulmonary resuscitation. (b) Classification. Class I (general controls). The device is exempt from the... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Cardiopulmonary emergency cart. 868.6175 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Miscellaneous § 868.6175 Cardiopulmonary emergency cart...

21 CFR 868.6175 - Cardiopulmonary emergency cart.

Code of Federal Regulations, 2010 CFR

2010-04-01

... cardiopulmonary resuscitation. (b) Classification. Class I (general controls). The device is exempt from the... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Cardiopulmonary emergency cart. 868.6175 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Miscellaneous § 868.6175 Cardiopulmonary emergency cart...

21 CFR 868.6175 - Cardiopulmonary emergency cart.

Code of Federal Regulations, 2014 CFR

2014-04-01

... cardiopulmonary resuscitation. (b) Classification. Class I (general controls). The device is exempt from the... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Cardiopulmonary emergency cart. 868.6175 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Miscellaneous § 868.6175 Cardiopulmonary emergency cart...

21 CFR 868.6175 - Cardiopulmonary emergency cart.

Code of Federal Regulations, 2012 CFR

2012-04-01

... cardiopulmonary resuscitation. (b) Classification. Class I (general controls). The device is exempt from the... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Cardiopulmonary emergency cart. 868.6175 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Miscellaneous § 868.6175 Cardiopulmonary emergency cart...

21 CFR 868.6175 - Cardiopulmonary emergency cart.

Code of Federal Regulations, 2013 CFR

2013-04-01

... cardiopulmonary resuscitation. (b) Classification. Class I (general controls). The device is exempt from the... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Cardiopulmonary emergency cart. 868.6175 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Miscellaneous § 868.6175 Cardiopulmonary emergency cart...

Identification of a Novel Host-Specific IgM Protease in Streptococcus suis

PubMed Central

Seele, Jana; Singpiel, Alena; Spoerry, Christian; von Pawel-Rammingen, Ulrich; Valentin-Weigand, Peter

2013-01-01

Streptococcus suis serotype 2 is a highly invasive, extracellular pathogen in pigs with the capacity to cause severe infections in humans. This study was initiated by the finding that IgM degradation products are released after opsonization of S. suis. The objective of this work was to identify the bacterial factor responsible for IgM degradation. The results of this study showed that a member of the IdeS family, designated IdeSsuis (Immunoglobulin M-degrading enzyme of S. suis), is responsible and sufficient for IgM cleavage. Recombinant IdeSsuis was found to degrade only IgM but neither IgG nor IgA. Interestingly, Western blot analysis revealed that IdeSsuis is host specific, as it exclusively cleaves porcine IgM but not IgM from six other species, including a closely related member of the Suidae family. As demonstrated by flow cytometry and immunofluorescence microscopy, IdeSsuis modulates binding of IgM to the bacterial surface. IdeSsuis is the first prokaryotic IgM-specific protease described, indicating that this enzyme is involved in a so-far-unknown mechanism of host-pathogen interaction at an early stage of the host immune response. Furthermore, cleavage of porcine IgM by IdeSsuis is the first identified phenotype reflecting functional adaptation of S. suis to pigs as the main host. PMID:23243300

21 CFR 870.2390 - Phonocardiograph.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) Identification. A phonocardiograph is a device used to amplify or condition the signal from a heart sound... display of the heart sounds. (b) Classification. Class I (general controls). The device is exempt from the...

21 CFR 870.2390 - Phonocardiograph.

Code of Federal Regulations, 2011 CFR

2011-04-01

...) Identification. A phonocardiograph is a device used to amplify or condition the signal from a heart sound... display of the heart sounds. (b) Classification. Class I (general controls). The device is exempt from the...

21 CFR 870.2390 - Phonocardiograph.

Code of Federal Regulations, 2013 CFR

2013-04-01

...) Identification. A phonocardiograph is a device used to amplify or condition the signal from a heart sound... display of the heart sounds. (b) Classification. Class I (general controls). The device is exempt from the...

21 CFR 870.2390 - Phonocardiograph.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) Identification. A phonocardiograph is a device used to amplify or condition the signal from a heart sound... display of the heart sounds. (b) Classification. Class I (general controls). The device is exempt from the...

21 CFR 870.2390 - Phonocardiograph.

Code of Federal Regulations, 2012 CFR

2012-04-01

...) Identification. A phonocardiograph is a device used to amplify or condition the signal from a heart sound... display of the heart sounds. (b) Classification. Class I (general controls). The device is exempt from the...

26 CFR 44.4402-1 - Exemptions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... section 4401 on any wager placed in a coin-operated device (as defined in section 4462 as in effect for... similar object, to operate a device described in section 4462(a)(2) (as so in effect). These devices... or tokens, has the features and characteristics of a gaming device whether or not evidence exists as...

77 FR 61768 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-11

... vasculature via partial occlusion of the descending aorta, including in patients with acute ischemic stroke... device is placed in the descending aorta. On March 30, 2005, a Humanitarian Device Exemption application... selectively stopping or controlling flow in the peripheral vasculature, which includes the descending aorta...

Lessons learned from IDeAl - 33 recommendations from the IDeAl-net about design and analysis of small population clinical trials.

PubMed

Hilgers, Ralf-Dieter; Bogdan, Malgorzata; Burman, Carl-Fredrik; Dette, Holger; Karlsson, Mats; König, Franz; Male, Christoph; Mentré, France; Molenberghs, Geert; Senn, Stephen

2018-05-11

IDeAl (Integrated designs and analysis of small population clinical trials) is an EU funded project developing new statistical design and analysis methodologies for clinical trials in small population groups. Here we provide an overview of IDeAl findings and give recommendations to applied researchers. The description of the findings is broken down by the nine scientific IDeAl work packages and summarizes results from the project's more than 60 publications to date in peer reviewed journals. In addition, we applied text mining to evaluate the publications and the IDeAl work packages' output in relation to the design and analysis terms derived from in the IRDiRC task force report on small population clinical trials. The results are summarized, describing the developments from an applied viewpoint. The main result presented here are 33 practical recommendations drawn from the work, giving researchers a comprehensive guidance to the improved methodology. In particular, the findings will help design and analyse efficient clinical trials in rare diseases with limited number of patients available. We developed a network representation relating the hot topics developed by the IRDiRC task force on small population clinical trials to IDeAl's work as well as relating important methodologies by IDeAl's definition necessary to consider in design and analysis of small-population clinical trials. These network representation establish a new perspective on design and analysis of small-population clinical trials. IDeAl has provided a huge number of options to refine the statistical methodology for small-population clinical trials from various perspectives. A total of 33 recommendations developed and related to the work packages help the researcher to design small population clinical trial. The route to improvements is displayed in IDeAl-network representing important statistical methodological skills necessary to design and analysis of small-population clinical trials. The methods are ready for use.

Differential cerebral deposition of IDE and NEP in sporadic and familial Alzheimer's disease.

PubMed

Dorfman, Verónica Berta; Pasquini, Laura; Riudavets, Miguel; López-Costa, Juan José; Villegas, Andrés; Troncoso, Juan Carlos; Lopera, Francisco; Castaño, Eduardo Miguel; Morelli, Laura

2010-10-01

Alzheimer's disease (AD) is characterized by amyloid beta (A beta) accumulation in the brain and is classified as familial early-onset (FAD) or sporadic late-onset (SAD). Evidences suggest that deficits in the brain expression of insulin degrading enzyme (IDE) and neprilysin (NEP), both proteases involved in amyloid degradation, may promote A beta deposition in SAD. We studied by immunohistochemistry IDE and NEP cortical expression in SAD and FAD samples carrying the E280A presenilin-1 missense mutation. We showed that IDE, a soluble peptidase, is linked with aggregated A beta 40 isoform while NEP, a membrane-bound protease, negatively correlates with amyloid angiopathy and its expression in the senile plaques is independent of aggregated amyloid and restricted to SAD cases. NEP, but not IDE, is over-expressed in dystrophic neurites, both proteases are immunoreactive in activated astrocytes but not in microglia and IDE was the only one detected in astrocytes of white matter from FAD cases. Collectively, our results support the notion that gross conformational changes involved in the modification from "natively folded-active" to "aggregated-inactive" IDE and NEP may be a relevant pathogenic mechanism in SAD. (c) 2008 Elsevier Inc. All rights reserved.

21 CFR 874.5550 - Powered nasal irrigator.

Code of Federal Regulations, 2011 CFR

2011-04-01

... pressure-controlled pulsating stream of water. The device consists of a control unit and pump connected to a spray tube and nozzle. (b) Classification. Class I (general controls). The device is exempt from...

21 CFR 874.5550 - Powered nasal irrigator.

Code of Federal Regulations, 2012 CFR

2012-04-01

... pressure-controlled pulsating stream of water. The device consists of a control unit and pump connected to a spray tube and nozzle. (b) Classification. Class I (general controls). The device is exempt from...

21 CFR 874.5550 - Powered nasal irrigator.

Code of Federal Regulations, 2013 CFR

2013-04-01

... pressure-controlled pulsating stream of water. The device consists of a control unit and pump connected to a spray tube and nozzle. (b) Classification. Class I (general controls). The device is exempt from...

21 CFR 874.5550 - Powered nasal irrigator.

Code of Federal Regulations, 2014 CFR

2014-04-01

... pressure-controlled pulsating stream of water. The device consists of a control unit and pump connected to a spray tube and nozzle. (b) Classification. Class I (general controls). The device is exempt from...

21 CFR 874.5550 - Powered nasal irrigator.

Code of Federal Regulations, 2010 CFR

2010-04-01

... pressure-controlled pulsating stream of water. The device consists of a control unit and pump connected to a spray tube and nozzle. (b) Classification. Class I (general controls). The device is exempt from...

21 CFR 862.1305 - Formiminoglutamic acid (FIGLU) test system.

Code of Federal Regulations, 2013 CFR

2013-04-01

... measurements obtained by this device are used in the diagnosis of anemias, such as pernicious anemia and congenital hemolytic anemia. (b) Classification. Class I (general controls). The device is exempt from the...

21 CFR 862.1305 - Formiminoglutamic acid (FIGLU) test system.

Code of Federal Regulations, 2011 CFR

2011-04-01

... measurements obtained by this device are used in the diagnosis of anemias, such as pernicious anemia and congenital hemolytic anemia. (b) Classification. Class I (general controls). The device is exempt from the...

21 CFR 876.5210 - Enema kit.

Code of Federal Regulations, 2010 CFR

2010-04-01

... to promote evacuation of the contents of the lower colon. The device consists of a container for... irrigation system (§ 876.5220). (b) Classification. Class I (general controls). The device is exempt from the...

Integration of an Apple II Plus Computer into an Existing Dual Axis Sun Tracker System.

DTIC Science & Technology

1984-06-01

Identify by block number) S, tpec l Sun Tracker System Solar Energy Apple II Plus Computer 20. ABSTRACT (’ ntlnue on reveree ide If neceesery end...14 4. Dual Axis Sun Tracker (Side View) ----------------- 15 5. Solar Tracker System Block Diagram ---------------- 17 6. Plug Wiring Diagram for Top...sources will be competitive. Already many homes have solar collectors and other devices designed to decrease the consumption of gas, oil, and

Elucidation of interactions of Alzheimer amyloid beta peptides (Abeta40 and Abeta42) with insulin degrading enzyme: a molecular dynamics study.

PubMed

Bora, Ram Prasad; Prabhakar, Rajeev

2010-05-11

In this study, interactions of the two full-length Alzheimer amyloid beta peptides (Abeta40 and Abeta42) with the fully active form of insulin degrading enzyme (IDE) through unrestrained, all-atom MD simulations have been investigated. This enzyme is a Zn-containing metallopeptidase that catalyzes the degradation of the monomeric forms of these peptides, and this process is critical for preventing the progression of Alzheimer's disease (AD). The available X-ray structures of the free and small fragment-bound (Asp1-Glu3 and Lys16-Asp23 of Abeta40 and Asp1-Glu3 and Lys16-Glu22 of Abeta42) mutated forms of IDE and NMR structures of the full-length Abeta40 and Abeta42 have been used to build the starting structures for these simulations. The most representative structures derived from the Abeta40-IDE and Abeta42-IDE simulations accurately reproduced the locations of the active site Zn(2+) metal and small fragments of the substrates and their interactions with the enzyme from the X-ray structures. The remaining fragments of both the substrates were found to interact with IDE through several hydrogen bonding, pi-pi, CH-pi, and NH-pi interactions. In comparison to Abeta40, Abeta42 is more flexible and interacts through a smaller number (17-22) of hydrogen bonds in the catalytic chamber of IDE. Both the substrates adopted more beta-sheet character in the IDE environment, an observation that is in line with experiments. Their structural characteristics inside IDE are significantly different than the ones observed in aqueous solution. The atomistic level details provided by these simulations can help in the elucidation of binding and degrading mechanisms of the Abeta peptides by IDE.

Somatostatin: a novel substrate and a modulator of insulin-degrading enzyme activity.

PubMed

Ciaccio, Chiara; Tundo, Grazia R; Grasso, Giuseppe; Spoto, Giuseppe; Marasco, Daniela; Ruvo, Menotti; Gioia, Magda; Rizzarelli, Enrico; Coletta, Massimo

2009-02-06

Insulin-degrading enzyme (IDE) is an interesting pharmacological target for Alzheimer's disease (AD), since it hydrolyzes beta-amyloid, producing non-neurotoxic fragments. It has also been shown that the somatostatin level reduction is a pathological feature of AD and that it regulates the neprilysin activity toward beta-amyloid. In this work, we report for the first time that IDE is able to hydrolyze somatostatin [k(cat) (s(-1))=0.38 (+/-0.05); K(m) (M)=7.5 (+/-0.9) x 10(-6)] at the Phe6-Phe7 amino acid bond. On the other hand, somatostatin modulates IDE activity, enhancing the enzymatic cleavage of a novel fluorogenic beta-amyloid through a decrease of the K(m) toward this substrate, which corresponds to the 10-25 amino acid sequence of the Abeta(1-40). Circular dichroism spectroscopy and surface plasmon resonance imaging experiments show that somatostatin binding to IDE brings about a concentration-dependent structural change of the secondary and tertiary structure(s) of the enzyme, revealing two possible binding sites. The higher affinity binding site disappears upon inactivation of IDE by ethylenediaminetetraacetic acid, which chelates the catalytic Zn(2+) ion. As a whole, these features suggest that the modulatory effect is due to an allosteric mechanism: somatostatin binding to the active site of one IDE subunit (where somatostatin is cleaved) induces an enhancement of IDE proteolytic activity toward fluorogenic beta-amyloid by another subunit. Therefore, this investigation on IDE-somatostatin interaction contributes to a more exhaustive knowledge about the functional and structural aspects of IDE and its pathophysiological implications in the amyloid deposition and somatostatin homeostasis in the brain.

21 CFR 862.2400 - Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use.

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND... element on a radiochromatogram. (b) Classification. Class I (general controls). The device is exempt from...

21 CFR 862.2400 - Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use.

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND... element on a radiochromatogram. (b) Classification. Class I (general controls). The device is exempt from...

21 CFR 862.2400 - Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use.

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND... element on a radiochromatogram. (b) Classification. Class I (general controls). The device is exempt from...

77 FR 22384 - Petition To Modify an Exemption of a Previously Approved Antitheft Device; Porsche

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-13

... passive, microprocessor-based device which includes a starter interrupt function, transponder key and a.... Porsche stated that the antitheft system consists of two major subsystems: a microprocessor-based...

75 FR 22174 - Petition To Modify an Exemption of a Previously Approved Antitheft Device; Porsche

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-27

... passive antitheft device installed on the Porsche Panamera includes a microprocessor-based immobilizer... modified antitheft system will now consist of a microprocessor based immobilizer system which prevents...

Demographic, procedural and 30-day safety results from the WEB Intra-saccular Therapy Study (WEB-IT).

PubMed

Fiorella, David; Molyneux, Andrew; Coon, Alexander; Szikora, Istvan; Saatci, Isil; Baltacioglu, Feyyaz; Sultan, Ali; Arthur, Adam

2017-12-01

The Woven EndoBridge (WEB) represents a novel intrasaccular therapeutic option for the treatment of intracranial wide-necked bifurcation aneurysms (WNBAs). The WEB-IT Study is a pivotal Investigational Device Exemption (IDE) study to determine the safety and effectiveness of the WEB device for the treatment of WNBAs located in the anterior and posterior intracranial circulations. We present the patient demographics, procedural characteristics, and 30-day adverse event data for the US WEB-IT study. WEB-IT is a prospective multicenter single-arm interventional study conducted at 25 US and 6 international centers. The study enrolled 150 adults with WNBAs of the anterior and posterior intracranial circulations. All patients were intended to receive a WEB device delivered via standard endovascular neurosurgical embolization techniques. The study was conducted under Good Clinical Practices and included independent adjudication effectiveness outcomes and all adverse events. One hundred and fifty patients enrolled at 27 investigational sites underwent attempted treatment with the WEB. Mean age was 59 years (range 29-79) and 110 (73.3%) of the patients were female. Treated aneurysms were located at the basilar apex (n=59, 39.3%), middle cerebral artery bifurcation (n=45, 30%), anterior communicating artery (n=40, 26.7%), and internal carotid artery terminus (n=6, 4%). Average aneurysm size was 6.4 mm (range 3.6-11.4) with a mean neck size of 4.8 mm (range 2.0-8.2, mean dome to neck ratio 1.34). Nine patients presented with ruptured aneurysms. Of the enrolled patients, 98.7% were treated successfully with WEB devices. Mean±SD fluoroscopy time was 30.2±15.7 min. One primary safety event (PSE) (0.7%)-a delayed parenchymal hemorrhage 22 days after treatment-occurred between the index procedure and 30-day follow-up. In addition to the single PSE, there were seven (4.7%) minor ischemic strokes (5 resolved without sequelae and 2 had a modified Rankin Scale score of 1 at 30 days), five (2.7%) transient ischemic attacks, and two (1.3%) minor subarachnoid hemorrhages, which did not meet the prospectively established criteria for PSEs. The WEB device can be used to treat WNBAs with a high level of procedural safety and a high degree of technical success. NCT02191618; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

21 CFR 886.1350 - Keratoscope.

Code of Federal Regulations, 2013 CFR

2013-04-01

...-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device... subject to § 886.9. The battery-powered device is exempt from the current good manufacturing practice...

21 CFR 886.1350 - Keratoscope.

Code of Federal Regulations, 2012 CFR

2012-04-01

...-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device... subject to § 886.9. The battery-powered device is exempt from the current good manufacturing practice...

21 CFR 886.1350 - Keratoscope.

Code of Federal Regulations, 2014 CFR

2014-04-01

...-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device... subject to § 886.9. The battery-powered device is exempt from the current good manufacturing practice...

21 CFR 886.1350 - Keratoscope.

Code of Federal Regulations, 2011 CFR

2011-04-01

...-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device... subject to § 886.9. The battery-powered device is exempt from the current good manufacturing practice...

21 CFR 886.1350 - Keratoscope.

Code of Federal Regulations, 2010 CFR

2010-04-01

...-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device... subject to § 886.9. The battery-powered device is exempt from the current good manufacturing practice...

16 CFR § 1500.85 - Exemptions from classification as banned hazardous substances.

Code of Federal Regulations, 2013 CFR

2013-01-01

... component has no hazards other than being in a self-pressurized container. (8) Model rocket propellant devices designed for use in light-weight, recoverable, and reflyable model rockets, provided such devices... recovery system activation devices intended for use with premanufactured model rocket engines wherein all...

16 CFR 1500.85 - Exemptions from classification as banned hazardous substances.

Code of Federal Regulations, 2014 CFR

2014-01-01

... component has no hazards other than being in a self-pressurized container. (8) Model rocket propellant devices designed for use in light-weight, recoverable, and reflyable model rockets, provided such devices... recovery system activation devices intended for use with premanufactured model rocket engines wherein all...

16 CFR 1500.85 - Exemptions from classification as banned hazardous substances.

Code of Federal Regulations, 2011 CFR

2011-01-01

... component has no hazards other than being in a self-pressurized container. (8) Model rocket propellant devices designed for use in light-weight, recoverable, and reflyable model rockets, provided such devices... recovery system activation devices intended for use with premanufactured model rocket engines wherein all...

21 CFR 872.3730 - Pantograph.

Code of Federal Regulations, 2010 CFR

2010-04-01

... lower jaw. (b) Classification. Class I (general controls). The device is exempt from the premarket... intended to be attached to a patient's head to duplicate lower jaw movements to aid in construction of restorative and prosthetic dental devices. A marking pen is attached to the lower jaw component of the device...

21 CFR 874.5840 - Antistammering device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... it senses the user's speech and that is intended to prevent the user from hearing the sounds of his or her own voice. The device is used to minimize a user's involuntary hesitative or repetitive speech. (b) Classification. Class I (general controls). The device is exempt from the premarket notification...

A globally distributed mobile genetic element inhibits natural transformation of Vibrio cholerae

PubMed Central

Dalia, Ankur B.; Seed, Kimberley D.; Calderwood, Stephen B.; Camilli, Andrew

2015-01-01

Natural transformation is one mechanism of horizontal gene transfer (HGT) in Vibrio cholerae, the causative agent of cholera. Recently, it was found that V. cholerae isolates from the Haiti outbreak were poorly transformed by this mechanism. Here, we show that an integrating conjugative element (ICE)-encoded DNase, which we name IdeA, is necessary and sufficient for inhibiting natural transformation of Haiti outbreak strains. We demonstrate that IdeA inhibits this mechanism of HGT in cis via DNA endonuclease activity that is localized to the periplasm. Furthermore, we show that natural transformation between cholera strains in a relevant environmental context is inhibited by IdeA. The ICE encoding IdeA is globally distributed. Therefore, we analyzed the prevalence and role for this ICE in limiting natural transformation of isolates from Bangladesh collected between 2001 and 2011. We found that IdeA+ ICEs were nearly ubiquitous in isolates from 2001 to 2005; however, their prevalence decreased to ∼40% from 2006 to 2011. Thus, IdeA+ ICEs may have limited the role of natural transformation in V. cholerae. However, the rise in prevalence of strains lacking IdeA may now increase the role of this conserved mechanism of HGT in the evolution of this pathogen. PMID:26240317

75 FR 6253 - Petition for Exemption From the Federal Motor Vehicle Theft Prevention Standard; Hyundia-Kia...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-08

...This document grants in full the Hyundai-Kia Motors Corporation (HATCI) petition for exemption of the Hyundai VI vehicle line in accordance with 49 CFR part 543, Exemption from Vehicle Theft Prevention Standard. This petition is granted because the agency has determined that the antitheft device to be placed on the line as standard equipment is likely to be as effective in reducing and deterring motor vehicle theft as compliance with the parts-marking requirements of 49 CFR part 541, Federal Motor Vehicle Theft Prevention Standard.

The 5-year cost-effectiveness of two-level anterior cervical discectomy and fusion or cervical disc replacement: a Markov analysis.

PubMed

Overley, Samuel C; McAnany, Steven J; Brochin, Robert L; Kim, Jun S; Merrill, Robert K; Qureshi, Sheeraz A

2018-01-01

Anterior cervical discectomy and fusion (ACDF) and cervical disc replacement (CDR) are both acceptable surgical options for the treatment of cervical myelopathy and radiculopathy. To date, there are limited economic analyses assessing the relative cost-effectiveness of two-level ACDF versus CDR. The purpose of this study was to determine the 5-year cost-effectiveness of two-level ACDF versus CDR. The study design is a secondary analysis of prospectively collected data. Patients in the Prestige cervical disc investigational device exemption (IDE) study who underwent either a two-level CDR or a two-level ACDF were included in the study. The outcome measures were cost and quality-adjusted life years (QALYs). A Markov state-transition model was used to evaluate data from the two-level Prestige cervical disc IDE study. Data from the 36-item Short Form Health Survey were converted into utilities using the short form (SF)-6D algorithm. Costs were calculated from the payer perspective. QALYs were used to represent effectiveness. A probabilistic sensitivity analysis (PSA) was performed using a Monte Carlo simulation. The base-case analysis, assuming a 40-year-old person who failed appropriate conservative care, generated a 5-year cost of $130,417 for CDR and $116,717 for ACDF. Cervical disc replacement and ACDF generated 3.45 and 3.23 QALYs, respectively. The incremental cost-effectiveness ratio (ICER) was calculated to be $62,337/QALY for CDR. The Monte Carlo simulation validated the base-case scenario. Cervical disc replacement had an average cost of $130,445 (confidence interval [CI]: $108,395-$152,761) with an average effectiveness of 3.46 (CI: 3.05-3.83). Anterior cervical discectomy and fusion had an average cost of $116,595 (CI: $95,439-$137,937) and an average effectiveness of 3.23 (CI: 2.84-3.59). The ICER was calculated at $62,133/QALY with respect to CDR. Using a $100,000/QALY willingness to pay (WTP), CDR is the more cost-effective strategy and would be selected 61.5% of the time by the simulation. Two-level CDR and ACDF are both cost-effective strategies at 5 years. Neither strategy was found to be more cost-effective with an ICER greater than the $50,000/QALY WTP threshold. The assumptions used in the analysis were strongly validated with the results of the PSA. Copyright © 2017 Elsevier Inc. All rights reserved.

21 CFR 888.4600 - Protractor for clinical use.

Code of Federal Regulations, 2011 CFR

2011-04-01

...) Identification. A protractor for clinical use is a device intended for use in measuring the angles of bones, such as on x-rays or in surgery. (b) Classification. Class I (general controls). The device is exempt from...

Testing Cobol Programs by Mutation. Volume II. CMS 1 System Documentation,

DTIC Science & Technology

1980-02-01

8217 LOOP MVth a’ solution was to enebese the macn depesi- 1F rumen Tom dent imes ide a apeelal type of mdulo called a G aaraadom(2); device maul* (see...software status register can be modified at will, while the required, but as an additional benefit, Modula contents of the buffer can be dealt with as...language. The requirements are stringent and usu- Dick up the contents of the address by Indirect ally the work Is never completed, an the uses for

Eicosapentaenoic acid and docosahexaenoic acid increase the degradation of amyloid-β by affecting insulin-degrading enzyme.

PubMed

Grimm, Marcus O W; Mett, Janine; Stahlmann, Christoph P; Haupenthal, Viola J; Blümel, Tamara; Stötzel, Hannah; Grimm, Heike S; Hartmann, Tobias

2016-12-01

Omega-3 polyunsaturated fatty acids (PUFAs) have been proposed to be highly beneficial in Alzheimer's disease (AD). AD pathology is closely linked to an overproduction and accumulation of amyloid-β (Aβ) peptides as extracellular senile plaques in the brain. Total Aβ levels are not only dependent on its production by proteolytic processing of the amyloid precursor protein (APP), but also on Aβ-clearance mechanisms, including Aβ-degrading enzymes. Here we show that the omega-3 PUFAs eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) increase Aβ-degradation by affecting insulin-degrading enzyme (IDE), the major Aβ-degrading enzyme secreted into the extracellular space of neuronal and microglial cells. The identification of the molecular mechanisms revealed that EPA directly increases IDE enzyme activity and elevates gene expression of IDE. DHA also directly stimulates IDE enzyme activity and affects IDE sorting by increasing exosome release of IDE, resulting in enhanced Aβ-degradation in the extracellular milieu. Apart from the known positive effect of DHA in reducing Aβ production, EPA and DHA might ameliorate AD pathology by increasing Aβ turnover.

Identification of residues in the insulin molecule important for binding to insulin-degrading enzyme.

PubMed

Affholter, J A; Cascieri, M A; Bayne, M L; Brange, J; Casaretto, M; Roth, R A

1990-08-21

Insulin-degrading enzyme (IDE) hydrolyzes insulin at a limited number of sites. Although the positions of these cleavages are known, the residues of insulin important in its binding to IDE have not been defined. To this end, we have studied the binding of a variety of insulin analogues to the protease in a solid-phase binding assay using immunoimmobilized IDE. Since IDE binds insulin with 600-fold greater affinity than it does insulin-like growth factor I (25 nM and approximately 16,000 nM, respectively), the first set of analogues studied were hybrid molecules of insulin and IGF I. IGF I mutants [insB1-17,17-70]IGF I, [Tyr55,Gln56]IGF I, and [Phe23,Phe24,Tyr25]IGF I have been synthesized and share the property of having insulin-like amino acids at positions corresponding to primary sites of cleavage of insulin by IDE. Whereas the first two exhibit affinities for IDE similar to that of wild type IGF I, the [Phe23,Phe24,Tyr25]IGF I analogue has a 32-fold greater affinity for the immobilized enzyme. Replacement of Phe-23 by Ser eliminates this increase. Removal of the eight amino acid D-chain region of IGF I (which has been predicted to interfere with binding to the 23-25 region) results in a 25-fold increase in affinity for IDE, confirming the importance of residues 23-25 in the high-affinity recognition of IDE. A similar role for the corresponding (B24-26) residues of insulin is supported by the use of site-directed mutant and semisynthetic insulin analogues. Insulin mutants [B25-Asp]insulin and [B25-His]insulin display 16- and 20-fold decreases in IDE affinity versus wild-type insulin.(ABSTRACT TRUNCATED AT 250 WORDS)

77 FR 71028 - Parts and Accessories Necessary for Safe Operation; Grant of Exemption for Transecurity LLC...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-28

... Carrier Safety Regulations (FMCSRs) currently require antennas, transponders, and similar devices to be... the driver's field of view by devices mounted at the top of the windshield. Antennas, transponders and...

Humanitarian Use Device and Humanitarian Device Exemption regulatory programs: pros and cons.

PubMed

Bernad, Daniel Maxwell

2009-03-01

The US FDA established the Humanitarian Use Device (HUD) and Humanitarian Device Exemption (HDE) program to encourage medical device firms to address rare diseases. Despite being in existence for over a decade, there has only been one peer-reviewed publication examining this field. The objective of this report is to investigate how the HUD/HDE program differs from the standard regulatory system, discuss its potential advantages and disadvantages, and to speculate which humanitarian devices will be brought to market within the next 5 years. A total of 40 semistructured interviews with stakeholders, representing approximately half (n = 20, 49%) of the firms that have successfully obtained HDE-approved products, were performed in order to acquire the primary data for this paper. There appear to be short-term gains and long-term drains associated with launching humanitarian devices to market. This report aims to provide sponsors with information that may allow them to make better decisions during their product development of humanitarian devices and may, hopefully, also play a role in encouraging other sponsors to take the necessary steps forward in helping to find treatments for patients with rare diseases.

77 FR 35112 - Petition To Modify an Exemption of a Previously Approved Antitheft Device; Ford Motor Company

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-12

... stated that the Fusion Titanium trim and Fusion Hybrid vehicles will be equipped with the IAwPB system as... Standard for the Ford Fusion vehicle line beginning with its model year (MY) 2012 vehicles. On February 16, 2012, Ford submitted a petition to modify its previously approved exemption for the Ford Fusion vehicle...

Fast-Response, Sensitivitive and Low-Powered Chemosensors by Fusing Nanostructured Porous Thin Film and IDEs-Microheater Chip

PubMed Central

Dai, Zhengfei; Xu, Lei; Duan, Guotao; Li, Tie; Zhang, Hongwen; Li, Yue; Wang, Yi; Wang, Yuelin; Cai, Weiping

2013-01-01

The chemiresistive thin film gas sensors with fast response, high sensitivity, low power consumption and mass-produced potency, have been expected for practical application. It requires both sensitive materials, especially exquisite nanomaterials, and efficient substrate chip for heating and electrical addressing. However, it is challenging to achieve repeatable microstructures across the films and low power consumption of substrate chip. Here we presented a new sensor structure via the fusion of metal-oxide nanoporous films and micro-electro-mechanical systems (MEMS)-based sensing chip. An interdigital-electrodes (IDEs) and microheater integrated MEMS structure is designed and employed as substrate chip to in-situ fabricate colloidal monolayer template-induced metal-oxide (egg. SnO2) nanoporous sensing films. This fused sensor demonstrates mW-level low power, ultrafast response (~1 s), and parts-per-billion lever detection for ethanol gas. Due to the controllable template strategy and mass-production potential, such micro/nano fused high-performance gas sensors will be next-generation key miniaturized/integrated devices for advanced practical applications. PMID:23591580

78 FR 53498 - Petition for Exemption From the Vehicle Theft Prevention Standard; Fuji Heavy Industries U.S.A...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-29

... identity, design, and location of the components of the antitheft device for the Subaru [confidential.... Additionally, FUSA stated that because the immobilization features are designed and constructed within the... provided a comparative table showing how its device is similar to other manufacturers' devices that have...

27 CFR 478.153 - Semiautomatic assault weapons and large capacity ammunition feeding devices manufactured or...

Code of Federal Regulations, 2011 CFR

2011-04-01

... weapons and large capacity ammunition feeding devices manufactured or imported for the purposes of testing... AMMUNITION Exemptions, Seizures, and Forfeitures § 478.153 Semiautomatic assault weapons and large capacity... weapon, and § 478.40a with respect to large capacity ammunition feeding devices, shall not apply to the...

27 CFR 478.153 - Semiautomatic assault weapons and large capacity ammunition feeding devices manufactured or...

Code of Federal Regulations, 2013 CFR

2013-04-01

... weapons and large capacity ammunition feeding devices manufactured or imported for the purposes of testing... AMMUNITION Exemptions, Seizures, and Forfeitures § 478.153 Semiautomatic assault weapons and large capacity... weapon, and § 478.40a with respect to large capacity ammunition feeding devices, shall not apply to the...

27 CFR 478.153 - Semiautomatic assault weapons and large capacity ammunition feeding devices manufactured or...

Code of Federal Regulations, 2014 CFR

2014-04-01

... weapons and large capacity ammunition feeding devices manufactured or imported for the purposes of testing... AMMUNITION Exemptions, Seizures, and Forfeitures § 478.153 Semiautomatic assault weapons and large capacity... weapon, and § 478.40a with respect to large capacity ammunition feeding devices, shall not apply to the...

27 CFR 478.153 - Semiautomatic assault weapons and large capacity ammunition feeding devices manufactured or...

Code of Federal Regulations, 2012 CFR

2012-04-01

... weapons and large capacity ammunition feeding devices manufactured or imported for the purposes of testing... AMMUNITION Exemptions, Seizures, and Forfeitures § 478.153 Semiautomatic assault weapons and large capacity... weapon, and § 478.40a with respect to large capacity ammunition feeding devices, shall not apply to the...

27 CFR 478.153 - Semiautomatic assault weapons and large capacity ammunition feeding devices manufactured or...

Code of Federal Regulations, 2010 CFR

2010-04-01

... weapons and large capacity ammunition feeding devices manufactured or imported for the purposes of testing... AMMUNITION Exemptions, Seizures, and Forfeitures § 478.153 Semiautomatic assault weapons and large capacity... weapon, and § 478.40a with respect to large capacity ammunition feeding devices, shall not apply to the...

21 CFR 884.5150 - Nonpowered breast pump.

Code of Federal Regulations, 2013 CFR

2013-04-01

... device used to express milk from the breast. (b) Classification. Class I. The device is exempt from the... 250 mm Hg suction, and the device materials that contact breast or breast milk do not produce... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Nonpowered breast pump. 884.5150 Section 884.5150...

21 CFR 884.5150 - Nonpowered breast pump.

Code of Federal Regulations, 2010 CFR

2010-04-01

... device used to express milk from the breast. (b) Classification. Class I. The device is exempt from the... 250 mm Hg suction, and the device materials that contact breast or breast milk do not produce... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Nonpowered breast pump. 884.5150 Section 884.5150...

21 CFR 884.5150 - Nonpowered breast pump.

Code of Federal Regulations, 2014 CFR

2014-04-01

... device used to express milk from the breast. (b) Classification. Class I. The device is exempt from the... 250 mm Hg suction, and the device materials that contact breast or breast milk do not produce... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Nonpowered breast pump. 884.5150 Section 884.5150...

21 CFR 884.5150 - Nonpowered breast pump.

Code of Federal Regulations, 2012 CFR

2012-04-01

... device used to express milk from the breast. (b) Classification. Class I. The device is exempt from the... 250 mm Hg suction, and the device materials that contact breast or breast milk do not produce... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nonpowered breast pump. 884.5150 Section 884.5150...

21 CFR 884.5150 - Nonpowered breast pump.

Code of Federal Regulations, 2011 CFR

2011-04-01

... device used to express milk from the breast. (b) Classification. Class I. The device is exempt from the... 250 mm Hg suction, and the device materials that contact breast or breast milk do not produce... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Nonpowered breast pump. 884.5150 Section 884.5150...

Beta oscillations in freely moving Parkinson's subjects are attenuated during deep brain stimulation.

PubMed

Quinn, Emma J; Blumenfeld, Zack; Velisar, Anca; Koop, Mandy Miller; Shreve, Lauren A; Trager, Megan H; Hill, Bruce C; Kilbane, Camilla; Henderson, Jaimie M; Brontë-Stewart, Helen

2015-11-01

Investigations into the effect of deep brain stimulation (DBS) on subthalamic (STN) beta (13-30 Hz) oscillations have been performed in the perioperative period with the subject tethered to equipment. Using an embedded sensing neurostimulator, this study investigated whether beta power was similar in different resting postures and during forward walking in freely moving subjects with Parkinson's disease (PD) and whether STN DBS attenuated beta power in a voltage-dependent manner. Subthalamic local field potentials were recorded from the DBS lead, using a sensing neurostimulator (Activa(®) PC+S, Medtronic, Inc., Food and Drug Administration- Investigational Device Exemption (IDE)-, institutional review board-approved) from 15 PD subjects (30 STNs) off medication during lying, sitting, and standing, during forward walking, and during randomized periods of 140 Hz DBS at 0 V, 1 V, and 2.5/3 V. Continuous video, limb angular velocity, and forearm electromyography recordings were synchronized with neural recordings. Data were parsed to avoid any movement or electrical artifact during resting states. Beta power was similar during lying, sitting, and standing (P = 0.077, n = 28) and during forward walking compared with the averaged resting state (P = 0.466, n = 24), although akinetic rigid PD subjects tended to exhibit decreased beta power when walking. Deep brain stimulation at 3 V and at 1 V attenuated beta power compared with 0 V (P < 0.003, n = 14), and this was voltage dependent (P < 0.001). Beta power was conserved during resting and forward walking states and was attenuated in a voltage-dependent manner during 140-Hz DBS. Phenotype may be an important consideration if this is used for closed-loop DBS. © 2015 International Parkinson and Movement Disorder Society.

Irreversible electroporation therapy in the management of locally advanced pancreatic adenocarcinoma.

PubMed

Martin, Robert C G; McFarland, Kelli; Ellis, Susan; Velanovich, Vic

2012-09-01

Locally advanced pancreatic cancer patients have limited options for disease control. Local ablation technologies based on thermal damage have been used but are associated with major complications in this region of the pancreas. Irreversible electroporation (IRE) is a nonthermal ablation technology that we have shown is safe near vital vascular and ductal structures. The aim of this study was to evaluate the safety and efficacy of IRE as a therapy in the treatment of locally advanced pancreatic cancer. We performed a prospective multi-institutional pilot evaluation of patients undergoing IRE for locally advanced pancreatic cancer from December 2009 to March 2011. These patients were evaluated for 90-day morbidity, mortality, and local disease control. Twenty-seven patients (13 women and 14 men) underwent IRE, with median age of 61 years (range 45 to 80 years). Eight patients underwent margin accentuation with IRE in combination with left-sided resection (n = 4) or pancreatic head resection (n = 4). Nineteen patients had in situ IRE. All patients underwent successful IRE, with intraoperative imaging confirming effective delivery of therapy. All 27 patients demonstrated nonclinically relevant elevation of their amylase and lipase, which peaked at 48 hours and returned to normal at 72 hour postprocedure. There has been one 90-day mortality. No patient has shown evidence of clinical pancreatitis or fistula formation. After all patients have completed 90-day follow-up, there has been 100% ablation success. IRE ablation of locally advanced pancreatic cancer tumors is a safe and feasible primary local treatment in unresectable, locally advanced disease. Confirming these early results must occur in a planned phase II investigational device exemption (IDE) study to be initiated in 2012. Copyright © 2012 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Effect on HBs antigen clearance of addition of pegylated interferon alfa-2a to nucleos(t)ide analogue therapy versus nucleos(t)ide analogue therapy alone in patients with HBe antigen-negative chronic hepatitis B and sustained undetectable plasma hepatitis B virus DNA: a randomised, controlled, open-label trial.

PubMed

Bourlière, Marc; Rabiega, Pascaline; Ganne-Carrie, Nathalie; Serfaty, Lawrence; Marcellin, Patrick; Barthe, Yoann; Thabut, Dominique; Guyader, Dominique; Hezode, Christophe; Picon, Magali; Causse, Xavier; Leroy, Vincent; Bronowicki, Jean Pierre; Carrieri, Patrizia; Riachi, Ghassan; Rosa, Isabelle; Attali, Pierre; Molina, Jean Michel; Bacq, Yannick; Tran, Albert; Grangé, Jean Didier; Zoulim, Fabien; Fontaine, Hélène; Alric, Laurent; Bertucci, Inga; Bouvier-Alias, Magali; Carrat, Fabrice

2017-03-01

Findings from uncontrolled studies suggest that addition of pegylated interferon in patients with HBe antigen (HBeAg)-negative chronic hepatitis B receiving nucleos(t)ide analogues with undetectable plasma hepatitis B virus (HBV) DNA might increase HBs antigen (HBsAg) clearance. We aimed to assess this strategy. In this randomised, controlled, open-label trial, we enrolled patients aged 18-75 years with HBeAg-negative chronic hepatitis B and documented negative HBV DNA while on stable nucleos(t)ide analogue regimens for at least 1 year from 30 hepatology tertiary care wards in France. Patients had to have an alanine aminotransferase concentration of less than or equal to five times the upper normal range, no hepatocellular carcinoma, and a serum α fetoprotein concentration of less than 50 ng/mL, normal dilated fundus oculi examination, and a negative pregnancy test in women. Patients with contraindications to pegylated interferon were not eligible. A centralised randomisation used computer-generated lists of random permuted blocks of four with stratification by HBsAg titres (< or ≥2·25 log 10 IU/mL) to allocate patients (1:1) to receive a 48 week course of subcutaneous injections of 180 μg per week of pegylated interferon alfa-2a in addition to the nucleos(t)ide analogue regimen or to continue to receive nucleos(t)ide analogues only. The primary endpoint was HBsAg loss at week 96 by intention-to-treat analysis. This trial is closed and registered with ClinicalTrials.gov, number NCT01172392. Between Jan 20, 2011, and July 18, 2012, we randomly allocated 185 patients (92 [50%] to pegylated interferon and nucleos(t)ide analogues and 93 [50%] to nucleos(t)ide analogues alone). We excluded two patients from the pegylated interferon plus nucleos(t)ide analogues group from analyses because of withdrawal of consent (one patient) or violation of inclusion criteria (one patient). At week 96, loss of HBsAg was reported in seven (7·8%) of 90 patients in the pegylated interferon plus nucleos(t)ide analogues group versus three (3·2%) of 93 in the nucleos(t)ide analogues-alone group (difference 4·6% [95% CI -2·6 to 12·5]; p=0·15). 85 (94%) of 90 patients started pegylated interferon, three (4%) of whom had a dose reduction and 17 (20%) had an early discontinuation of pegylated interferon (seven [41%] for serious adverse events). Grade 3 and 4 adverse events were more frequent in the pegylated interferon plus nucleos(t)ide analogues group (26 [29%] grade 3 adverse events; 19 [21%] grade 4 adverse events) than in the nucleos(t)ide analogues-alone group (three [3%] grade 3; six [6%] grade 4). Addition of a 48 week course of pegylated interferon to nucleos(t)ide analogue therapy in patients with HBeAg-negative chronic hepatitis B with undetectable HBV DNA for a least 1 year was poorly tolerated and did not result in a significant increase of HBsAg clearance. Institut national de la santé et de la recherche médicale-Agence nationale de recherches sur le sida et les hépatites virales (France Recherche Nord&sud Sida-vih Hepatites). Copyright © 2017 Elsevier Ltd. All rights reserved.

Genomic population structure of freshwater-resident and anadromous ide (Leuciscus idus) in north-western Europe.

PubMed

Skovrind, Mikkel; Olsen, Morten Tange; Vieira, Filipe Garrett; Pacheco, George; Carl, Henrik; Gilbert, M Thomas P; Møller, Peter Rask

2016-02-01

Climate change experts largely agree that future climate change and associated rises in oceanic water levels over the upcoming decades, will affect marine salinity levels. The subsequent effects on fish communities in estuarine ecosystems however, are less clear. One species that is likely to become increasingly affected by changes in salinity is the ide (Leuciscus idus). The ide is a stenohaline freshwater fish that primarily inhabits rivers, with frequent anadromous behavior when sea salinity does not exceed 15%. Unlike most other anadromous Baltic Sea fish species, the ide has yet to be subjected to large-scale stocking programs, and thus provides an excellent opportunity for studying the natural population structure across the current salinity gradient in the Danish Belts. To explore this, we used Genotyping-by-Sequencing to determine genomic population structure of both freshwater resident and anadromous ide populations in the western Baltic Sea region, and relate the results to the current salinity gradient and the demographic history of ide in the region. The sample sites separate into four clusters, with all anadromous populations in one cluster and the freshwater resident populations in the remaining three. Results demonstrate high level of differentiation between sites hosting freshwater resident populations, but little differentiation among anadromous populations. Thus ide exhibit the genomic population structure of both a typical freshwater species, and a typical anadromous species. In addition to providing a first insight into the population structure of north-western European ide, our data also (1) provide indications of a single illegal introduction by man; (2) suggest limited genetic effects of heavy pollution in the past; and (3) indicate possible historical anadromous behavior in a now isolated freshwater population.

Increasing Diversity in the Earth Sciences - Impact of the IDES Program in Oregon

NASA Astrophysics Data System (ADS)

de Silva, S. L.; Guerrero, E. F.; Duncan, R. A.; de Silva, L. L.; Eriksson, S. C.

2014-12-01

The NSF-OEDG funded Increasing Diversity in the Earth Sciences (IDES) program hosted at Oregon State University targets undergraduate students from diverse backgrounds and diverse ethnicity to engage in research. Partnering with local community colleges, non-traditional students are the hallmark of this program. The IDES program has several components to support the students in the transition from community college to the four-year universities of Oregon State University and Portland State University. Over the four years, the program has adapted while adhering to its primary goals: (1) to increase the number of students from underrepresented groups who prepare for and pursue careers in Earth Science research and education, and (2) to strengthen the understanding of Earth Sciences and their relevance to society among broad and diverse segments of the population. Now in its final year under an extension, 53 participants have participated in the program. An ongoing external evaluation of the program reveals that the various stakeholders consider IDES very successful. Participant surveys and interviews document several impacts: expanded opportunities, making professional contacts, building self-confidence, enhanced ability to be employable, and personal acknowledgement. Research mentors and administrators from partner institutions see positive impacts on the students and on their organizations. Challenges include better communication between the IDES program, mentors, and students. IDES is poised to move forward with its current experiences and successes as a foundation for further funding. IDES-like activities can be funded from private sources and it is a good fit for funding from Research Experiences for Undergraduates at NSF. The new emphasis on education and research at community colleges is an exciting opportunity and Oregon State University has already used aspects of the IDES program in current grant proposals to obtain funds for more undergraduate research.

78 FR 76702 - Parts and Accessories Necessary for Safe Operation; Application for an Exemption From Volvo...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-18

... Regulations (FMCSRs) currently require antennas, transponders, and similar devices to be located not more than... the driver's field of view by devices mounted at the top of the windshield. Antennas, transponders and...

21 CFR 808.1 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

...(a) does not preempt State or local provisions respecting delegations of authority and related... FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS General Provisions § 808.1 Scope... exemption from Federal preemption of State and local requirements applicable to medical devices under...

Liberation of Desmosine and Isodesmosine as Amino Acids from Insoluble Elastin by Elastolytic Proteases

PubMed Central

Umeda, Hideyuki; Aikawa, Masanori; Libby, Peter

2011-01-01

The development of atherosclerotic lesions and abdominal aortic aneurysms involves degradation and loss of extracellular matrix components, such as collagen and elastin. Releases of the elastin cross-links desmosine (DES) and isodesmosine (IDE) may reflect elastin degradation in cardiovascular diseases. This study investigated the production of soluble elastin cross-linking structures by proteinases implicated in arterial diseases. Recombinant MMP-12 and neutrophil elastase liberated DES and IDE as amino acids from insoluble elastin. DES and IDE were also released from insoluble elastin exposed to monocyte/macrophage cell lines or human primary macrophages derived from peripheral blood monocytes. Elastin oxidized by reactive oxygen species (ROS) liberated more unconjugated DES and IDE than did non-oxidized elastin when incubated with MMP-12 or neutrophil elastase. These results support the exploration of free DES and IDE as biomarkers of elastin degradation. PMID:21726534

Prospective, randomized multicenter study of cervical arthroplasty versus anterior cervical discectomy and fusion: 5-year results with a metal-on-metal artificial disc.

PubMed

Coric, Domagoj; Guyer, Richard D; Nunley, Pierce D; Musante, David; Carmody, Cameron; Gordon, Charles; Lauryssen, Carl; Boltes, Margaret O; Ohnmeiss, Donna D

2018-03-01

OBJECTIVE Seven cervical total disc replacement (TDR) devices have received FDA approval since 2006. These devices represent a heterogeneous assortment of implants made from various biomaterials with different biomechanical properties. The majority of these devices are composed of metallic endplates with a polymer core. In this prospective, randomized multicenter study, the authors evaluate the safety and efficacy of a metal-on-metal (MoM) TDR (Kineflex|C) versus anterior cervical discectomy and fusion (ACDF) in the treatment of single-level spondylosis with radiculopathy through a long-term (5-year) follow-up. METHODS An FDA-regulated investigational device exemption (IDE) pivotal trial was conducted at 21 centers across the United States. Standard validated outcome measures including the Neck Disability Index (NDI) and visual analog scale (VAS) for assessing pain were used. Patients were randomized to undergo TDR using the Kineflex|C cervical artificial disc or anterior cervical fusion using structural allograft and an anterior plate. Patients were evaluated preoperatively and at 6 weeks and 3, 6, 12, 24, 36, 48, and 60 months after surgery. Serum ion analysis was performed on a subset of patients randomized to receive the MoM TDR. RESULTS A total of 269 patients were enrolled and randomly assigned to undergo either TDR (136 patients) or ACDF (133 patients). There were no significant differences between the TDR and ACDF groups in terms of operative time, blood loss, or length of hospital stay. In both groups, the mean NDI scores improved significantly by 6 weeks after surgery and remained significantly improved throughout the 60-month follow-up (both p < 0.01). Similarly, VAS pain scores improved significantly by 6 weeks and remained significantly improved through the 60-month follow-up (both p < 0.01). There were no significant changes in outcomes between the 24- and 60-month follow-ups in either group. Range of motion in the TDR group decreased at 3 months but was significantly greater than the preoperative mean value at the 12- and 24-month follow-ups and remained significantly improved through the 60-month period. There were no significant differences between the 2 groups in terms of reoperation/revision surgery or device-/surgery-related adverse events. The serum ion analysis revealed cobalt and chromium levels significantly lower than the levels that merit monitoring. CONCLUSIONS Cervical TDR with an MoM device is safe and efficacious at the 5-year follow-up. These results from a prospective randomized study support that Kineflex|C TDR as a viable alternative to ACDF in appropriately selected patients with cervical radiculopathy. Clinical trial registration no.: NCT00374413 (clinicaltrials.gov).

Analysis of high-order SNP barcodes in mitochondrial D-loop for chronic dialysis susceptibility.

PubMed

Yang, Cheng-Hong; Lin, Yu-Da; Chuang, Li-Yeh; Chang, Hsueh-Wei

2016-10-01

Positively identifying disease-associated single nucleotide polymorphism (SNP) markers in genome-wide studies entails the complex association analysis of a huge number of SNPs. Such large numbers of SNP barcode (SNP/genotype combinations) continue to pose serious computational challenges, especially for high-dimensional data. We propose a novel exploiting SNP barcode method based on differential evolution, termed IDE (improved differential evolution). IDE uses a "top combination strategy" to improve the ability of differential evolution to explore high-order SNP barcodes in high-dimensional data. We simulate disease data and use real chronic dialysis data to test four global optimization algorithms. In 48 simulated disease models, we show that IDE outperforms existing global optimization algorithms in terms of exploring ability and power to detect the specific SNP/genotype combinations with a maximum difference between cases and controls. In real data, we show that IDE can be used to evaluate the relative effects of each individual SNP on disease susceptibility. IDE generated significant SNP barcode with less computational complexity than the other algorithms, making IDE ideally suited for analysis of high-order SNP barcodes. Copyright © 2016 Elsevier Inc. All rights reserved.

Femtosecond laser ablation of gold interdigitated electrodes for electronic tongues

NASA Astrophysics Data System (ADS)

Manzoli, Alexandra; de Almeida, Gustavo F. B.; Filho, José A.; Mattoso, Luiz H. C.; Riul, Antonio; Mendonca, Cleber R.; Correa, Daniel S.

2015-06-01

Electronic tongue (e-tongue) sensors based on impedance spectroscopy have emerged as a potential technology to evaluate the quality and chemical composition of food, beverages, and pharmaceuticals. E-tongues usually employ transducers based on metal interdigitated electrodes (IDEs) coated with a thin layer of an active material, which is capable of interacting chemically with several types of analytes. IDEs are usually produced by photolithographic methods, which are time-consuming and costly, therefore, new fabrication technologies are required to make it more affordable. Here, we employed femtosecond laser ablation with pulse duration of 50 fs to microfabricate gold IDEs having finger width from 2.3 μm up to 3.2 μm. The parameters used in the laser ablation technique, such as light intensity, scan speed and beam spot size have been optimized to achieve uniform IDEs, which were characterized by optical and scanning electron microscopy. The electrical properties of gold IDEs fabricated by laser ablation were evaluated by impedance spectroscopy, and compared to those produced by conventional photolithography. The results show that femtosecond laser ablation is a promising alternative to conventional photolithography for fabricating metal IDEs for e-tongue systems.

Inhibition of Insulin Degrading Enzyme and Insulin Degradation by UV-Killed Lactobacillus acidophilus.

PubMed

Neyazi, Nadia; Motevaseli, Elahe; Khorramizadeh, Mohammad Reza; Mohammadi Farsani, Taiebeh; Nouri, Zahra; Nasli Esfahani, Ensieh; Ghahremani, Mohammad Hossein

2018-05-11

Probiotics have beneficial effects on management of type 2 diabetes (T2D). The major hallmarks of T2D are insulin deficiency and insulin resistance which emphasize insulin therapy in onset of disease. Lactobacilli such as Lactobacillus acidophilus ( L. acidophilus ) have well known properties on prevention of T2D and insulin resistance but not on insulin degradation. Insulin-degrading enzyme (IDE) degrades insulin in the human body. We studied the effects of cell-free supernatant (CFS) and ultraviolet (UV)-killed L. acidophilus (ATCC 314) on IDE activity and insulin degradation in vitro. Cell growth inhibition by CFS and UV-killed L. acidophilus (ATCC 314) was studied and Western blotting and a fluoregenic assay was performed to determine IDE expression and its activity, respectively. Insulin degradation was evaluated by sandwich enzyme-linked immunosorbent assay(ELISA). IDE expression and activity was reduced by CFS and UV-killed L. acidophilus (ATCC 314). Although, decreased enzyme expression and activity was not significant for CFS in contrast to MRL (MRS with same pH as CFS). Also, reduction in IDE activity was not statistically considerable when compared to IDE expression. Insulin degradation was increased by CFS but decreased by UV-killed L. acidophilus (ATCC 314).

21 CFR 866.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 866.9 Section 866.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY...

21 CFR 866.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 866.9 Section 866.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY...

21 CFR 866.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 866.9 Section 866.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY...

21 CFR 866.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 866.9 Section 866.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY...

78 FR 46406 - Parts and Accessories Necessary for Safe Operation; Application for an Exemption From Help, Inc.

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-31

... Regulations (FMCSRs) currently require antennas, transponders, and similar devices to be located not more than.... Antennas, transponders and similar devices must not be mounted more than 152 mm (6 inches) below the upper...

21 CFR 862.1365 - Glutathione test system.

Code of Federal Regulations, 2011 CFR

2011-04-01

....1365 Glutathione test system. (a) Identification. A glutathione test system is a device intended to measure glutathione (the tripeptide of glycine, cysteine, and glutamic acid) in erythrocytes (red blood... I (general controls). The device is exempt from the premarket notification procedures in subpart E...

21 CFR 862.1365 - Glutathione test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

....1365 Glutathione test system. (a) Identification. A glutathione test system is a device intended to measure glutathione (the tripeptide of glycine, cysteine, and glutamic acid) in erythrocytes (red blood... I (general controls). The device is exempt from the premarket notification procedures in subpart E...

21 CFR 862.1365 - Glutathione test system.

Code of Federal Regulations, 2013 CFR

2013-04-01

....1365 Glutathione test system. (a) Identification. A glutathione test system is a device intended to measure glutathione (the tripeptide of glycine, cysteine, and glutamic acid) in erythrocytes (red blood... I (general controls). The device is exempt from the premarket notification procedures in subpart E...

21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical devices for processing, repacking, or manufacturing. 801.122 Section 801.122 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND..., repacking, or use in the manufacture of another drug or device shall be exempt from section 502(f)(1) of the...

21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices for processing, repacking, or manufacturing. 801.122 Section 801.122 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND..., repacking, or use in the manufacture of another drug or device shall be exempt from section 502(f)(1) of the...

21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical devices for processing, repacking, or manufacturing. 801.122 Section 801.122 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND..., repacking, or use in the manufacture of another drug or device shall be exempt from section 502(f)(1) of the...

21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical devices for processing, repacking, or manufacturing. 801.122 Section 801.122 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND..., repacking, or use in the manufacture of another drug or device shall be exempt from section 502(f)(1) of the...

21 CFR 862.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND... purpose, or the device is intended for lay use where the former intended use was by health care... of immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic...

21 CFR 884.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OBSTETRICAL AND GYNECOLOGICAL... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 862.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND... purpose, or the device is intended for lay use where the former intended use was by health care... of immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic...

21 CFR 876.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 864.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 884.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OBSTETRICAL AND GYNECOLOGICAL... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 862.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND... purpose, or the device is intended for lay use where the former intended use was by health care... of immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic...

21 CFR 876.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 876.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 864.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 884.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OBSTETRICAL AND GYNECOLOGICAL... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 876.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 862.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND... purpose, or the device is intended for lay use where the former intended use was by health care... of immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic...

21 CFR 864.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 864.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 884.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OBSTETRICAL AND GYNECOLOGICAL... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

Development of a Sensitive Electrochemical Enzymatic Reaction-Based Cholesterol Biosensor Using Nano-Sized Carbon Interdigitated Electrodes Decorated with Gold Nanoparticles

PubMed Central

Sharma, Deepti; Lee, Jongmin; Seo, Junyoung; Shin, Heungjoo

2017-01-01

We developed a versatile and highly sensitive biosensor platform. The platform is based on electrochemical-enzymatic redox cycling induced by selective enzyme immobilization on nano-sized carbon interdigitated electrodes (IDEs) decorated with gold nanoparticles (AuNPs). Without resorting to sophisticated nanofabrication technologies, we used batch wafer-level carbon microelectromechanical systems (C-MEMS) processes to fabricate 3D carbon IDEs reproducibly, simply, and cost effectively. In addition, AuNPs were selectively electrodeposited on specific carbon nanoelectrodes; the high surface-to-volume ratio and fast electron transfer ability of AuNPs enhanced the electrochemical signal across these carbon IDEs. Gold nanoparticle characteristics such as size and morphology were reproducibly controlled by modulating the step-potential and time period in the electrodeposition processes. To detect cholesterol selectively using AuNP/carbon IDEs, cholesterol oxidase (ChOx) was selectively immobilized via the electrochemical reduction of the diazonium cation. The sensitivity of the AuNP/carbon IDE-based biosensor was ensured by efficient amplification of the redox mediators, ferricyanide and ferrocyanide, between selectively immobilized enzyme sites and both of the combs of AuNP/carbon IDEs. The presented AuNP/carbon IDE-based cholesterol biosensor exhibited a wide sensing range (0.005–10 mM) and high sensitivity (~993.91 µA mM−1 cm−2; limit of detection (LOD) ~1.28 µM). In addition, the proposed cholesterol biosensor was found to be highly selective for the cholesterol detection. PMID:28914766

Zn(II) stimulation of Fe(II)-activated repression in the iron-dependent repressor from Mycobacterium tuberculosis.

PubMed

Stapleton, Brian; Walker, Lawrence R; Logan, Timothy M

2013-03-19

Thermodynamic measurements of Fe(II) binding and activation of repressor function in the iron-dependent repressor from Mycobacterium tuberculosis (IdeR) are reported. IdeR, a member of the diphtheria toxin repressor family of proteins, regulates iron homeostasis and contributes to the virulence response in M. tuberculosis. Although iron is the physiological ligand, this is the first detailed analysis of iron binding and activation in this protein. The results showed that IdeR binds 2 equiv of Fe(II) with dissociation constants that differ by a factor of 25. The high- and low-affinity iron binding sites were assigned to physical binding sites I and II, respectively, using metal binding site mutants. IdeR was also found to contain a high-affinity Zn(II) binding site that was assigned to physical metal binding site II through the use of binding site mutants and metal competition assays. Fe(II) binding was modestly weaker in the presence of Zn(II), but the coupled metal binding-DNA binding affinity was significantly stronger, requiring 30-fold less Fe(II) to activate DNA binding compared to Fe(II) alone. Together, these results suggest that IdeR is a mixed-metal repressor, where Zn(II) acts as a structural metal and Fe(II) acts to trigger the physiologically relevant promoter binding. This new model for IdeR activation provides a better understanding of IdeR and the biology of iron homeostasis in M. tuberculosis.

Physical vapor deposited thin films of lignins extracted from sugar cane bagasse: morphology, electrical properties, and sensing applications.

PubMed

Volpati, Diogo; Machado, Aislan D; Olivati, Clarissa A; Alves, Neri; Curvelo, Antonio A S; Pasquini, Daniel; Constantino, Carlos J L

2011-09-12

The concern related to the environmental degradation and to the exhaustion of natural resources has induced the research on biodegradable materials obtained from renewable sources, which involves fundamental properties and general application. In this context, we have fabricated thin films of lignins, which were extracted from sugar cane bagasse via modified organosolv process using ethanol as organic solvent. The films were made using the vacuum thermal evaporation technique (PVD, physical vapor deposition) grown up to 120 nm. The main objective was to explore basic properties such as electrical and surface morphology and the sensing performance of these lignins as transducers. The PVD film growth was monitored via ultraviolet-visible (UV-vis) absorption spectroscopy and quartz crystal microbalance, revealing a linear relationship between absorbance and film thickness. The 120 nm lignin PVD film morphology presented small aggregates spread all over the film surface on the nanometer scale (atomic force microscopy, AFM) and homogeneous on the micrometer scale (optical microscopy). The PVD films were deposited onto Au interdigitated electrode (IDE) for both electrical characterization and sensing experiments. In the case of electrical characterization, current versus voltage (I vs V) dc measurements were carried out for the Au IDE coated with 120 nm lignin PVD film, leading to a conductivity of 3.6 × 10(-10) S/m. Using impedance spectroscopy, also for the Au IDE coated with the 120 nm lignin PVD film, dielectric constant of 8.0, tan δ of 3.9 × 10(-3), and conductivity of 1.75 × 10(-9) S/m were calculated at 1 kHz. As a proof-of-principle, the application of these lignins as transducers in sensing devices was monitored by both impedance spectroscopy (capacitance vs frequency) and I versus time dc measurements toward aniline vapor (saturated atmosphere). The electrical responses showed that the sensing units are sensible to aniline vapor with the process being reversible. AFM images conducted directly onto the sensing units (Au IDE coated with 120 nm lignin PVD film) before and after the sensing experiments showed a decrease in the PVD film roughness from 5.8 to 3.2 nm after exposing to aniline.

21 CFR 874.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2010 CFR

2010-04-01

... device operates using a different fundamental scientific technology than a legally marketed device in... cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a...

21 CFR 872.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2010 CFR

2010-04-01

... device operates using a different fundamental scientific technology than a legally marketed device in... cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a...

21 CFR 886.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2010 CFR

2010-04-01

... device operates using a different fundamental scientific technology than a legally marketed device in... cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a...

21 CFR 890.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2010 CFR

2010-04-01

... device operates using a different fundamental scientific technology than a legally marketed device in... cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a...

21 CFR 870.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2010 CFR

2010-04-01

... device operates using a different fundamental scientific technology than a legally marketed device in... cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a...

21 CFR 892.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2010 CFR

2010-04-01

... device operates using a different fundamental scientific technology than a legally marketed device in... cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a...

21 CFR 882.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2010 CFR

2010-04-01

... device operates using a different fundamental scientific technology than a legally marketed device in... cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a...

21 CFR 888.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2010 CFR

2010-04-01

... device operates using a different fundamental scientific technology than a legally marketed device in... cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a...

21 CFR 868.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2010 CFR

2010-04-01

... device operates using a different fundamental scientific technology than a legally marketed device in... cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a...

21 CFR 864.6600 - Osmotic fragility test.

Code of Federal Regulations, 2011 CFR

2011-04-01

... test. (a) Identification. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions. (b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...

21 CFR 864.6600 - Osmotic fragility test.

Code of Federal Regulations, 2012 CFR

2012-04-01

... test. (a) Identification. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions. (b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...

21 CFR 864.6600 - Osmotic fragility test.

Code of Federal Regulations, 2014 CFR

2014-04-01

... test. (a) Identification. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions. (b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...

21 CFR 864.6600 - Osmotic fragility test.

Code of Federal Regulations, 2013 CFR

2013-04-01

... test. (a) Identification. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions. (b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...

21 CFR 864.6600 - Osmotic fragility test.

Code of Federal Regulations, 2010 CFR

2010-04-01

... test. (a) Identification. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions. (b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...

40 CFR 63.2250 - What are the general requirements?

Code of Federal Regulations, 2012 CFR

2012-07-01

..., except during periods of process unit or control device startup, shutdown, and malfunction; prior to process unit initial startup; and during the routine control device maintenance exemption specified in... practice requirements are not operating, or during periods of startup, shutdown, and malfunction. Startup...

40 CFR 63.2250 - What are the general requirements?

Code of Federal Regulations, 2013 CFR

2013-07-01

..., except during periods of process unit or control device startup, shutdown, and malfunction; prior to process unit initial startup; and during the routine control device maintenance exemption specified in... practice requirements are not operating, or during periods of startup, shutdown, and malfunction. Startup...

40 CFR 63.2250 - What are the general requirements?

Code of Federal Regulations, 2014 CFR

2014-07-01

..., except during periods of process unit or control device startup, shutdown, and malfunction; prior to process unit initial startup; and during the routine control device maintenance exemption specified in... practice requirements are not operating, or during periods of startup, shutdown, and malfunction. Startup...

Fabrication and characterization of spiral interdigitated electrodes based biosensor for salivary glucose detection

NASA Astrophysics Data System (ADS)

Adelyn, P. Y. P.; Hashim, U.; Arshad, M. K. Md; Voon, C. H.; Liu, Wei-Wen; Kahar, S. M.; Huda, A. R. N.; Lee, H. Cheun

2017-03-01

This work introduces the non-invasive glucose monitoring technique by using the Complementary Metal Oxide Semiconductor (CMOS) technologically fabricated spiral Interdigitated Electrodes (IDE) based biosensor. Scanning Electron Microscopy (SEM) image explores the morphology of spiral IDE while Energy Dispersive X-Ray (EDX) determines the elements induced in spiral IDE. Oral saliva of two patients are collected and tested on the spiral IDE sensor with electrical characterization as glucose detection results. However, both patients exhibit their glucose level characteristics inconsistently. Therefore, this work could be extended and enhanced by adding Glutaraldehyde in between 3-Aminoproply)triethoxysilane (APTES) modified and glucose oxidase (GOD) enzyme immobilized layer with FTIR validation for bonding attachment.

CoINcIDE: A framework for discovery of patient subtypes across multiple datasets.

PubMed

Planey, Catherine R; Gevaert, Olivier

2016-03-09

Patient disease subtypes have the potential to transform personalized medicine. However, many patient subtypes derived from unsupervised clustering analyses on high-dimensional datasets are not replicable across multiple datasets, limiting their clinical utility. We present CoINcIDE, a novel methodological framework for the discovery of patient subtypes across multiple datasets that requires no between-dataset transformations. We also present a high-quality database collection, curatedBreastData, with over 2,500 breast cancer gene expression samples. We use CoINcIDE to discover novel breast and ovarian cancer subtypes with prognostic significance and novel hypothesized ovarian therapeutic targets across multiple datasets. CoINcIDE and curatedBreastData are available as R packages.

Characterization of the terminal stages of chlorophyll (ide) synthesis in etioplast membrane preparations.

PubMed Central

Griffiths, W T

1975-01-01

1. Chlorophyll (ide) formation from protochlorophyll (ide) that is normally inactive was demonstrated in etioplast membranes isolated from maize and barlley plants, the process being dependent on intermittent illumination and the addition of NADPH. 2. The addition of NADPH to the membranes was shown to result in the conversion of inactive protochlorophyll (ide) absorbing at about 630 nm into a form(s) with light-absorption maxima at about 640 and 652 nm, both of which disappear when chlorophyll (ide) is formed on illumination. 3. The temperature-dependence of the activation process and its response to a variety of reagents were examined. From these, the conclusion is drawn that -SH groups are involved in the activation but in the active complex these are unavailable for reaction with -SH reagents. 4. Evidence is presented for the occurrence of glucose 6-phosphate dehydrogenase activity within etioplasts and the suggestion is made that the oxidative pentose phosphate pathway can provide the NADPH required for chlorophyll biosynthesis during the early stages of greening. PMID:5998

The Examination of Real Property Tax Exemptions: An Example of Land Use Planning for Fiscal Gain. Exchange Bibliography No. 172.

ERIC Educational Resources Information Center

Martin, Larry R. G.

This selected bibliography focuses on property tax exemptions in urban areas and on the ability of cities to generate property tax revenues. It begins with a review of some relationships between the property tax and land use planning. Then, the role of the property tax as one of several devices employed in fiscally-oriented planning is examined.…

Non-clinical and Pre-clinical Testing to Demonstrate Safety of the Barostim Neo Electrode for Activation of Carotid Baroreceptors in Chronic Human Implants

PubMed Central

Wilks, Seth J.; Hara, Seth A.; Ross, Erika K.; Nicolai, Evan N.; Pignato, Paul A.; Cates, Adam W.; Ludwig, Kip A.

2017-01-01

The Barostim neo™ electrode was developed by CVRx, Inc.to deliver baroreflex activation therapy (BAT)™ to treat hypertension and heart failure. The neo electrode concept was designed to deliver electrical stimulation to the baroreceptors within the carotid sinus bulb, while minimizing invasiveness of the implant procedure. This device is currently CE marked in Europe, and in a Pivotal (akin to Phase III) Trial in the United States. Here we present the in vitro and in vivo safety testing that was completed in order to obtain necessary regulatory approval prior to conducting human studies in Europe, as well as an FDA Investigational Device Exemption (IDE) to conduct a Pivotal Trial in the United States. Stimulated electrodes (10 mA, 500 μs, 100 Hz) were compared to unstimulated electrodes using optical microscopy and several electrochemical techniques over the course of 27 weeks. Electrode dissolution was evaluated by analyzing trace metal content of solutions in which electrodes were stimulated. Lastly, safety testing under Good Laboratory Practice guidelines was conducted in an ovine animal model over a 12 and 24 week time period, with results processed and evaluated by an independent histopathologist. Long-term stimulation testing indicated that the neo electrode with a sputtered iridium oxide coating can be stimulated at maximal levels for the lifetime of the implant without clinically significant dissolution of platinum or iridium, and without increasing the potential at the electrode interface to cause hydrolysis or significant tissue damage. Histological examination of tissue that was adjacent to the neo electrodes indicated no clinically significant signs of increased inflammation and no arterial stenosis as a result of 6 months of continuous stimulation. The work presented here involved rigorous characterization and evaluation testing of the neo electrode, which was used to support its safety for chronic implantation. The testing strategies discussed provide a starting point and proven framework for testing new neuromodulation electrode concepts to support regulatory approval for clinical studies. PMID:28824361

21 CFR 878.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 880.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 880.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 878.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 878.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 880.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 880.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

21 CFR 878.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

Peptidomics approach to elucidate the proteolytic regulation of bioactive peptides

PubMed Central

Kim, Yun-Gon; Lone, Anna Mari; Nolte, Whitney M.; Saghatelian, Alan

2012-01-01

Peptide hormones and neuropeptides have important roles in physiology and therefore the regulation of these bioactive peptides is of great interest. In some cases proteolysis controls the concentrations and signaling of bioactive peptides, and the peptidases that mediate this biochemistry have proven to be extremely successful drug targets. Due to the lack of any general method to identify these peptidases, however, the role of proteolysis in the regulation of most neuropeptides and peptide hormones is unknown. This limitation prompted us to develop an advanced peptidomics-based strategy to identify the peptidases responsible for the proteolysis of significant bioactive peptides. The application of this approach to calcitonin gene-related peptide (CGRP), a neuropeptide associated with blood pressure and migraine, revealed the endogenous CGRP cleavage sites. This information was then used to biochemically purify the peptidase capable of proteolysis of CGRP at those cleavage sites, which led to the identification of insulin-degrading enzyme (IDE) as a candidate CGRP-degrading enzyme. CGRP had not been identified as an IDE substrate before and we tested the physiological relevance of this interaction by quantitative measurements of CGRP using IDE null (IDE−/−) mice. In the absence of IDE, full-length CGRP levels are elevated in vivo, confirming IDE as an endogenous CGRP-degrading enzyme. By linking CGRP and IDE, this strategy uncovers a previously unknown pathway for CGRP regulation and characterizes an additional role for IDE. More generally, this work suggests that this may be an effective general strategy for characterizing these pathways and peptidases moving forward. PMID:22586115

Electrical DNA biosensor using aluminium interdigitated electrode for E.Coli O157:H7 detection

NASA Astrophysics Data System (ADS)

Natasha, N. Z.; Rajapaksha, R. D. A. A.; Uda, M. N. A.; Hashim, U.

2017-09-01

Escherichia Coli (E.Coli) O157:H7 is the one of the most dangerous foodborne pathogens based diseases that presence in our daily life that causes illness and death increase every year. Aluminum Interdigitated Electrode (Al IDE) biosensor was introduced to detect E.Coli O157:H7 in earlier stage. In this paper we investigated ssDNA of E.Coli O157:H7 bacteria detection through electrical behavior of Al IDE sensor. The physical properties of Al IDE biosensor has been characterized using Low Power Microscope (LPM), High Power Microscope (HPM), Scanning Electron Microscope (SEM) and 3D Nano Profiler. The bare Al IDE was electrical characterized by using I-V measurement. The surface modification was accomplished by salinization using APTES and immobilization using Carboxylic Probe E.Coli which was the first step in preparing Al IDE biosensor. Geared up prepared biosensor was hybridized with complementary, non-complementary and single based mismatch ssDNA to confirmed specificity detection of E Coli O157:H7 ssDNA target. The Current - Voltage was performed for each step such as bare Al IDE, surface modification, immobilization and hybridization. Sensitivity measurement was accomplished using different concentration of complementary ssDNA target from 1 fM - 10 µM. Selectivity measurements was achieved using same concentration which was 10 µM concentration for complement, non-complement and mismatch E.Coli O157:H7 ssDNA target. It's totally proved that the Al IDE able to detect specific and small current down to Femtomolar concentration.

75 FR 50036 - Petition To Modify an Exemption of a Previously Approved Antitheft Device; Ford Motor Company

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-16

... standard equipment or the optional Intelligent Access with Push Button Start (IAwPB). Key components of the... and reports back to the BCM whether a valid key was found. In both devices, if the codes do not match...

21 CFR 880.2920 - Clinical mercury thermometer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Clinical mercury thermometer. 880.2920 Section 880... Devices § 880.2920 Clinical mercury thermometer. (a) Identification. A clinical mercury thermometer is a... mercury. (b) Classification. Class II (special controls). The device is exempt from the premarket...

21 CFR 880.2920 - Clinical mercury thermometer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Clinical mercury thermometer. 880.2920 Section 880... Devices § 880.2920 Clinical mercury thermometer. (a) Identification. A clinical mercury thermometer is a... mercury. (b) Classification. Class II (special controls). The device is exempt from the premarket...

21 CFR 880.2920 - Clinical mercury thermometer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Clinical mercury thermometer. 880.2920 Section 880... Devices § 880.2920 Clinical mercury thermometer. (a) Identification. A clinical mercury thermometer is a... mercury. (b) Classification. Class II (special controls). The device is exempt from the premarket...

21 CFR 880.2920 - Clinical mercury thermometer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Clinical mercury thermometer. 880.2920 Section 880... Devices § 880.2920 Clinical mercury thermometer. (a) Identification. A clinical mercury thermometer is a... mercury. (b) Classification. Class II (special controls). The device is exempt from the premarket...

21 CFR 862.1670 - Sorbitol dehydrogenase test system.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Systems § 862.1670 Sorbitol dehydrogenase test system. (a) Identification. A sorbitol dehydrogenase test system is a device intended to measure the activity of the enzyme sorbitol dehydrogenase in serum... cirrhosis or acute hepatitis. (b) Classification. Class I (general controls). The device is exempt from the...

21 CFR 880.5630 - Nipple shield.

Code of Federal Regulations, 2011 CFR

2011-04-01

... nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

21 CFR 880.5630 - Nipple shield.

Code of Federal Regulations, 2013 CFR

2013-04-01

... nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

21 CFR 880.5630 - Nipple shield.

Code of Federal Regulations, 2014 CFR

2014-04-01

... nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

21 CFR 880.5630 - Nipple shield.

Code of Federal Regulations, 2010 CFR

2010-04-01

... nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

21 CFR 880.5630 - Nipple shield.

Code of Federal Regulations, 2012 CFR

2012-04-01

... nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

21 CFR 866.5490 - Hemopexin immunological test system.

Code of Federal Regulations, 2012 CFR

2012-04-01

... survival of mature red blood cells and inability of the bone marrow to compensate for their decreased life span) and sickle cell anemia. (b) Classification. Class II (special controls). The device is exempt... Hemopexin immunological test system. (a) Indentification. A hemopexin immunological test system is a device...

21 CFR 866.5490 - Hemopexin immunological test system.

Code of Federal Regulations, 2011 CFR

2011-04-01

... survival of mature red blood cells and inability of the bone marrow to compensate for their decreased life span) and sickle cell anemia. (b) Classification. Class II (special controls). The device is exempt... Hemopexin immunological test system. (a) Indentification. A hemopexin immunological test system is a device...

21 CFR 862.1650 - Pyruvate kinase test system.

Code of Federal Regulations, 2013 CFR

2013-04-01

....1650 Pyruvate kinase test system. (a) Identification. A pyruvate kinase test system is a device intended to measure the activity of the enzyme pyruvate kinase in erythrocytes (red blood cells...). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

21 CFR 862.1650 - Pyruvate kinase test system.

Code of Federal Regulations, 2011 CFR

2011-04-01

....1650 Pyruvate kinase test system. (a) Identification. A pyruvate kinase test system is a device intended to measure the activity of the enzyme pyruvate kinase in erythrocytes (red blood cells...). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

21 CFR 866.5360 - Cohn fraction IV immuno-logical test system.

Code of Federal Regulations, 2012 CFR

2012-04-01

...-lipoprotein), malnutrition, iron deficiency anemia, red blood cell disorders, and kidney disease. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in... test system is a device that consists of or measures that fraction of plasma proteins, predominantly...

21 CFR 866.5490 - Hemopexin immunological test system.

Code of Federal Regulations, 2013 CFR

2013-04-01

... survival of mature red blood cells and inability of the bone marrow to compensate for their decreased life span) and sickle cell anemia. (b) Classification. Class II (special controls). The device is exempt... Hemopexin immunological test system. (a) Indentification. A hemopexin immunological test system is a device...

21 CFR 866.5360 - Cohn fraction IV immuno-logical test system.

Code of Federal Regulations, 2011 CFR

2011-04-01

...-lipoprotein), malnutrition, iron deficiency anemia, red blood cell disorders, and kidney disease. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in... test system is a device that consists of or measures that fraction of plasma proteins, predominantly...

21 CFR 862.1650 - Pyruvate kinase test system.

Code of Federal Regulations, 2014 CFR

2014-04-01

....1650 Pyruvate kinase test system. (a) Identification. A pyruvate kinase test system is a device intended to measure the activity of the enzyme pyruvate kinase in erythrocytes (red blood cells...). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

21 CFR 866.5360 - Cohn fraction IV immuno-logical test system.

Code of Federal Regulations, 2014 CFR

2014-04-01

...-lipoprotein), malnutrition, iron deficiency anemia, red blood cell disorders, and kidney disease. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in... test system is a device that consists of or measures that fraction of plasma proteins, predominantly...

21 CFR 866.5490 - Hemopexin immunological test system.

Code of Federal Regulations, 2014 CFR

2014-04-01

... survival of mature red blood cells and inability of the bone marrow to compensate for their decreased life span) and sickle cell anemia. (b) Classification. Class II (special controls). The device is exempt... Hemopexin immunological test system. (a) Indentification. A hemopexin immunological test system is a device...

21 CFR 862.1650 - Pyruvate kinase test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

....1650 Pyruvate kinase test system. (a) Identification. A pyruvate kinase test system is a device intended to measure the activity of the enzyme pyruvate kinase in erythrocytes (red blood cells...). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

21 CFR 862.1650 - Pyruvate kinase test system.

Code of Federal Regulations, 2012 CFR

2012-04-01

....1650 Pyruvate kinase test system. (a) Identification. A pyruvate kinase test system is a device intended to measure the activity of the enzyme pyruvate kinase in erythrocytes (red blood cells...). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

21 CFR 866.5360 - Cohn fraction IV immuno-logical test system.

Code of Federal Regulations, 2013 CFR

2013-04-01

...-lipoprotein), malnutrition, iron deficiency anemia, red blood cell disorders, and kidney disease. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in... test system is a device that consists of or measures that fraction of plasma proteins, predominantly...

40 CFR 63.2250 - What are the general requirements?

Code of Federal Regulations, 2011 CFR

2011-07-01

... periods of process unit or control device startup, shutdown, and malfunction; prior to process unit initial startup; and during the routine control device maintenance exemption specified in § 63.2251. The... are not operating, or during periods of startup, shutdown, and malfunction. Startup and shutdown...

40 CFR 63.2250 - What are the general requirements?

Code of Federal Regulations, 2010 CFR

2010-07-01

... periods of process unit or control device startup, shutdown, and malfunction; prior to process unit initial startup; and during the routine control device maintenance exemption specified in § 63.2251. The... are not operating, or during periods of startup, shutdown, and malfunction. Startup and shutdown...

Understanding the Slow Transient Optoelectronic Response of Hybrid Organic-Inorganic Halide Perovskites

NASA Astrophysics Data System (ADS)

Jacobs, Daniel Louis

Hybrid organic-inorganic halide perovskites, particularly methylammonium lead triiodide (MAPbI3), have emerged within the past decade as an exciting class of photovoltaic materials. In less than ten years, MAPbI3-based photovoltaic devices have seen unprecedented performance growth, with photoconversion efficiency increasing from 3% to over 22%, making it competitive with traditional high-efficiency solar cells. Furthermore, the fabrication of MAPbI3 devices utilize low-temperature solution processing, which could facilitate ultra low cost manufacturing. However, MAPbI3 suffers from significant instabilities under working conditions that have limited their applications outside of the laboratory. The instability of the MAPbI3 material can be generalized as a complex, slow transient optoelectronic response (STOR). The mechanism of the generalized STOR is dependent on the native defects of MAPbI3, but detailed understanding of the material defect properties is complicated by the complex ionic bonding of MAPbI3. Furthermore, characterization of the intrinsic material's response is complicated by the diverse approach to material processing and device architecture across laboratories around the world. In order to understand and mitigate the significant problems of MAPbI3 devices, a new approach focused on the material response, rather than the full device response, must be pursued. This dissertation highlights the work to analyze and mitigate the STOR intrinsic to MAPbI3. An experimental platform was developed based on lateral interdigitated electrode (IDE) arrays capable of monitoring the current and photoluminescence response simultaneously. By correlating the dynamics of the current and photoluminescence (PL) responses, both charge trapping and ion migration mechanisms were identified to contribute to the STOR. Next, a novel fabrication technique is introduced that is capable of reliably depositing MAPbI3 thin films with grain sizes at least an order of magnitude larger than most common techniques. These films were studied with confocal microscopy to give insight into the intra-grain PL dynamics of MAPbI3. Finally, the lateral IDE device platform was used to study the composition and morphology dependent STOR and revealed important correlations between defect formation and the STOR. These results represent an important step toward realizing a deeper understanding of the intrinsic limitations of MAPbI3 needed to progress the technology outside of the laboratory.

Impedance biosensor for the rapid detection of Listeria spp. based on aptamer functionalized Pt-interdigitated microelectrodes array

NASA Astrophysics Data System (ADS)

Sidhu, R.; Rong, Y.; Vanegas, D. C.; Claussen, J.; McLamore, E. S.; Gomes, C.

2016-05-01

Listeria monocytogenes is one of the most common causes of food illness deaths worldwide, with multiple outbreaks in the United States alone. Current methods to detect foodborne pathogens are laborious and can take several hours to days to produce results. Thus, faster techniques are needed to detect bacteria within the same reliability level as traditional techniques. This study reports on a rapid, accurate, and sensitive aptamer biosensor device for Listeria spp. detection based on platinum interdigitated array microelectrodes (Pt-IDEs). Pt-IDEs with different geometric electrode gaps were fabricated by lithographic techniques and characterized by cyclic voltammetric (CV), electrochemical impedance spectroscopy (EIS), and potential amperometry (DCPA) measurements of reversible redox species. Based on these results, 50 μm Pt-IDE was chosen to further functionalize with a Listeria monocytogenes DNA aptamer selective to the cell surface protein internalin A, via metal-thiol self-assembly at the 5' end of the 47-mer's. EIS analysis was used to detect Listeria spp. without the need for label amplification and pre-concentration steps. The optimized aptamer concentration of 800 nM was selected to capture the bacteria through internalin A binding and the aptamer hairpin structure near the 3' end. The aptasensor was capable of detecting a wide range of bacteria concentration from 10 to 106 CFU/mL at lower detection limit of 5.39 +/- 0.21 CFU/mL with sensitivity of 268.1 +/- 25.40 (Ohms/log [CFU/mL]) in 17 min. The aptamer based biosensor offers a portable, rapid and sensitive alternative for food safety applications with one of the lowest detection limits reported to date.

Immunohistochemical evidence of ubiquitous distribution of the metalloendoprotease insulin-degrading enzyme (IDE; insulysin) in human non-malignant tissues and tumor cell lines.

PubMed

Weirich, Gregor; Mengele, Karin; Yfanti, Christina; Gkazepis, Apostolos; Hellmann, Daniela; Welk, Anita; Giersig, Cecylia; Kuo, Wen-Liang; Rosner, Marsha Rich; Tang, Wei-Jen; Schmitt, Manfred

2008-11-01

Immunohistochemical evidence of ubiquitous distribution of the metalloprotease insulin-degrading enzyme (IDE; insulysin) in human non-malignant tissues and tumor cells is presented. Immunohistochemical staining was performed on a multi-organ tissue microarray (pancreas, lung, kidney, central/peripheral nervous system, liver, breast, placenta, myocardium, striated muscle, bone marrow, thymus, and spleen) and on a cell microarray of 31 tumor cell lines of different origin, as well as trophoblast cells and normal blood lymphocytes and granulocytes. IDE protein was expressed in all the tissues assessed and all the tumor cell lines except for Raji and HL-60. Trophoblast cells and granulocytes, but not normal lymphocytes, were also IDE-positive.

Immunohistochemical evidence for ubiquitous distribution of metalloendoprotease insulin-degrading enzyme (IDE; insulysin) in human non-malignant tissues and tumor cell lines

PubMed Central

Weirich, Gregor; Mengele, Karin; Yfanti, Christina; Gkazepis, Apostolos; Hellmann, Daniela; Welk, Anita; Giersig, Cecylia; Kuo, Wen-Liang; Rosner, Marsha Rich; Tang, Wei-Jen; Schmitt, Manfred

2013-01-01

Immunohistochemical evidence for ubiquitous distribution of metalloprotease insulin-degrading enzyme (IDE; insulysin) in human non-malignant tissues and tumor cells is presented. Immunohistochemical staining was performed on a multi-organ tissue microarray (pancreas, lung, kidney, central/peripheral nervous system, liver, breast, placenta, myocardium, striated muscle, bone marrow, thymus, spleen) and on a cell microarray encompassing 31 tumor cell lines of different origin plus trophoblast cells, and normal blood lymphocytes and granulocytes. IDE protein is expressed by all of the tissues assessed and in all of the tumor cell lines except Raji and HL-60; trophoblast cells and granulocytes but not normal lymphocytes are also IDE-positive. PMID:18783335

21 CFR 880.6265 - Examination gown.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Examination gown. 880.6265 Section 880.6265 Food... § 880.6265 Examination gown. (a) Identification. An examination gown is a device intended for medical... covering during a medical examination. (b) Classification. Class I (general controls). The device is exempt...

78 FR 14015 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Patient Transport

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-04

... for Safety--Collateral Standard: Electromagnetic Compatibility--Requirements and Tests,'' and ASME A18.1 ``Safety Standard for Platform Lifts and Stairway Chair Lifts'') must validate electromagnetic...: Electromagnetic Compatibility--Requirements and Tests,'' and ASME A18.1 ``Safety Standard for Platform Lifts and...

21 CFR 862.1720 - Triose phosphate isomerase test system.

Code of Federal Regulations, 2014 CFR

2014-04-01

... isomerase test system is a device intended to measure the activity of the enzyme triose phosphate isomerase in erythrocytes (red blood cells). Triose phosphate isomerase is an enzyme important in glycolysis... device is exempt from the premarket notification procedures in subpart E of part 807 subject to the...

21 CFR 862.1720 - Triose phosphate isomerase test system.

Code of Federal Regulations, 2013 CFR

2013-04-01

... isomerase test system is a device intended to measure the activity of the enzyme triose phosphate isomerase in erythrocytes (red blood cells). Triose phosphate isomerase is an enzyme important in glycolysis... device is exempt from the premarket notification procedures in subpart E of part 807 subject to the...

21 CFR 864.7675 - Leukocyte peroxidase test.

Code of Federal Regulations, 2011 CFR

2011-04-01

... cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their... peroxidase test. (a) Identification. A leukocyte peroxidase test is a device used to distinguish certain... of the leukemias. (b) Classification. Class I (general controls). This device is exempt from the...

21 CFR 864.7675 - Leukocyte peroxidase test.

Code of Federal Regulations, 2013 CFR

2013-04-01

... cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their... peroxidase test. (a) Identification. A leukocyte peroxidase test is a device used to distinguish certain... of the leukemias. (b) Classification. Class I (general controls). This device is exempt from the...

21 CFR 864.7675 - Leukocyte peroxidase test.

Code of Federal Regulations, 2012 CFR

2012-04-01

... cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their... peroxidase test. (a) Identification. A leukocyte peroxidase test is a device used to distinguish certain... of the leukemias. (b) Classification. Class I (general controls). This device is exempt from the...

21 CFR 864.7675 - Leukocyte peroxidase test.

Code of Federal Regulations, 2010 CFR

2010-04-01

... cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their... peroxidase test. (a) Identification. A leukocyte peroxidase test is a device used to distinguish certain... of the leukemias. (b) Classification. Class I (general controls). This device is exempt from the...

21 CFR 864.7675 - Leukocyte peroxidase test.

Code of Federal Regulations, 2014 CFR

2014-04-01

... cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their... peroxidase test. (a) Identification. A leukocyte peroxidase test is a device used to distinguish certain... of the leukemias. (b) Classification. Class I (general controls). This device is exempt from the...

21 CFR 862.1720 - Triose phosphate isomerase test system.

Code of Federal Regulations, 2012 CFR

2012-04-01

... isomerase test system is a device intended to measure the activity of the enzyme triose phosphate isomerase in erythrocytes (red blood cells). Triose phosphate isomerase is an enzyme important in glycolysis... device is exempt from the premarket notification procedures in subpart E of part 807 subject to the...

21 CFR 880.5090 - Liquid bandage.

Code of Federal Regulations, 2013 CFR

2013-04-01

... powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant. (b) Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E...

21 CFR 880.5090 - Liquid bandage.

Code of Federal Regulations, 2011 CFR

2011-04-01

... powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant. (b) Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E...

21 CFR 880.5090 - Liquid bandage.

Code of Federal Regulations, 2014 CFR

2014-04-01

... powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant. (b) Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E...

21 CFR 880.5090 - Liquid bandage.

Code of Federal Regulations, 2012 CFR

2012-04-01

... powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant. (b) Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E...

21 CFR 886.1200 - Optokinetic drum.

Code of Federal Regulations, 2010 CFR

2010-04-01

... optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be... of the eyeball) in patients. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the...

21 CFR 886.1200 - Optokinetic drum.

Code of Federal Regulations, 2011 CFR

2011-04-01

... optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be... of the eyeball) in patients. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the...

21 CFR 886.1200 - Optokinetic drum.

Code of Federal Regulations, 2014 CFR

2014-04-01

... optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be... of the eyeball) in patients. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the...

21 CFR 886.1200 - Optokinetic drum.

Code of Federal Regulations, 2013 CFR

2013-04-01

... optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be... of the eyeball) in patients. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the...

21 CFR 886.1200 - Optokinetic drum.

Code of Federal Regulations, 2012 CFR

2012-04-01

... optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be... of the eyeball) in patients. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the...

21 CFR 880.5090 - Liquid bandage.

Code of Federal Regulations, 2010 CFR

2010-04-01

... powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant. (b) Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E...

21 CFR 812.30 - FDA action on applications.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false FDA action on applications. 812.30 Section 812.30...) MEDICAL DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Application and Administrative Action § 812.30 FDA action on applications. (a) Approval or disapproval. FDA will notify the sponsor in writing of the date...

21 CFR 812.30 - FDA action on applications.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false FDA action on applications. 812.30 Section 812.30...) MEDICAL DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Application and Administrative Action § 812.30 FDA action on applications. (a) Approval or disapproval. FDA will notify the sponsor in writing of the date...

21 CFR 812.30 - FDA action on applications.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false FDA action on applications. 812.30 Section 812.30...) MEDICAL DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Application and Administrative Action § 812.30 FDA action on applications. (a) Approval or disapproval. FDA will notify the sponsor in writing of the date...

21 CFR 812.30 - FDA action on applications.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false FDA action on applications. 812.30 Section 812.30...) MEDICAL DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Application and Administrative Action § 812.30 FDA action on applications. (a) Approval or disapproval. FDA will notify the sponsor in writing of the date...

21 CFR 812.30 - FDA action on applications.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false FDA action on applications. 812.30 Section 812.30...) MEDICAL DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Application and Administrative Action § 812.30 FDA action on applications. (a) Approval or disapproval. FDA will notify the sponsor in writing of the date...

IDeF-X ECLAIRs: A CMOS ASIC for the Readout of CdTe and CdZnTe Detectors for High Resolution Spectroscopy

NASA Astrophysics Data System (ADS)

Gevin, Olivier; Baron, Pascal; Coppolani, Xavier; Daly, FranÇois; Delagnes, Eric; Limousin, Olivier; Lugiez, Francis; Meuris, Aline; Pinsard, FrÉdÉric; Renaud, Diana

2009-08-01

The very last member of the IDeF-X ASIC family is presented: IDeF-X ECLAIRs is a 32-channel front end ASIC designed for the readout of Cadmium Telluride (CdTe) and Cadmium Zinc Telluride (CdZnTe) Detectors. Thanks to its noise performance (Equivalent Noise Charge floor of 33 e- rms) and to its radiation hardened design (Single Event Latchup Linear Energy Transfer threshold of 56 MeV.cm2.mg-1), the chip is well suited for soft X-rays energy discrimination and high energy resolution, ldquospace proof,rdquo hard X-ray spectroscopy. We measured an energy low threshold of less than 4 keV with a 10 pF input capacitor and a minimal reachable sensitivity of the Equivalent Noise Charge (ENC) to input capacitance of less than 7 e-/pF obtained with a 6 mus peak time. IDeF-X ECLAIRs will be used for the readout of 6400 CdTe Schottky monopixel detectors of the 2D coded mask imaging telescope ECLAIRs aboard the SVOM satellite. IDeF-X ECLAIRs (or IDeF-X V2) has also been designed for the readout of a pixelated CdTe detector in the miniature spectro-imager prototype Caliste 256 that is currently foreseen for the high energy detector module of the Simbol-X mission.

Guidance for the emergency use of unapproved medical devices; availability--FDA. Notice.

PubMed

1985-10-22

The Food and Drug Administration (FDA) is announcing guidance, developed by FDA's Center for Devices and Radiological Health (CDRH), with respect to those emergency situations in which the agency would not object to a physician's using a potentially life-saving medical device for a use for which the device ordinarily is required to have, but does not have, an approved application for premarket approval or an investigational device exemption. The guidance is contained in a document entitled "guidance for the Emergency Use of Unapproved Medical Devices."

New technique for fertilizing eggs of burbot, asp and ide under hatchery conditions.

PubMed

Kucharczyk, Dariusz; Nowosad, Joanna; Łuczyński, Marek J; Targońska, Katarzyna

2016-09-01

The development of a new protocol for egg fertilization may increase embryo survival and benefit the aquaculture process. In the present study, a new technique of partially adding sperm to activated eggs in the artificial fertilization of burbot (Lota lota), ide (Leuciscus idus) and asp (Aspius aspius) eggs was evaluated. If the same volume of sperm was divided into two or three parts and added to eggs in 30-60s intervals, it significantly improved embryo survival at the eyed-egg-stage of development. In the present study, the periodic addition of spermatozoa to eggs affected fertilization (ide and asp) and embryo survival rates (ide, asp and burbot) and might be successfully applied under hatchery conditions. Copyright © 2016 Elsevier B.V. All rights reserved.

27 CFR 555.141 - Exemptions.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., fertilizers, propellant actuated devices, or propellant actuated industrial tools manufactured, imported, or distributed for their intended purposes. (9) Industrial and laboratory chemicals which are intended for use as...

27 CFR 555.141 - Exemptions.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., fertilizers, propellant actuated devices, or propellant actuated industrial tools manufactured, imported, or distributed for their intended purposes. (9) Industrial and laboratory chemicals which are intended for use as...

27 CFR 555.141 - Exemptions.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., fertilizers, propellant actuated devices, or propellant actuated industrial tools manufactured, imported, or distributed for their intended purposes. (9) Industrial and laboratory chemicals which are intended for use as...

Governance in Open Source Software Development Projects: Towards a Model for Network-Centric Edge Organizations

DTIC Science & Technology

2008-06-01

project is not an isolated OSSD project. Instead, the NetBeans IDE which is the focus of development activities in the NetBeans.org project community...facilitate or constrain the intended usage of the NetBeans IDE. Figure 1 provides a rendering of some of the more visible OSSD projects that...as BioBeans and RefactorIT communities build tools on top of or extending the NetBeans platform or IDE. How do these organizations interact with

A Software Agent Toolkit for Effective Information Processing in the Battle Command Domain

DTIC Science & Technology

2006-11-01

the ADE will be based on a popular Integrated Development Environment (IDE) such as NetBeans or Eclipse. We further specified that the IDE is to be...JBuilder, NetBeans , and Eclipse. We quickly eliminated Visual Studio and JBuilder because they did not meet our basic requirements of being Java...based and freely obtainable. This left us with NetBeans and Eclipse. Each is a solid IDE with features that permit extensions well suited to our

21 CFR 870.4200 - Cardiopulmonary bypass accessory equipment.

Code of Federal Regulations, 2010 CFR

2010-04-01

....4200 Section 870.4200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... class I if it does not involve an electrical connection to the patient. The device is exempt from the... (special controls). The device is classified as class II if it involves an electrical connection to the...

21 CFR 870.4200 - Cardiopulmonary bypass accessory equipment.

Code of Federal Regulations, 2011 CFR

2011-04-01

....4200 Section 870.4200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... class I if it does not involve an electrical connection to the patient. The device is exempt from the... (special controls). The device is classified as class II if it involves an electrical connection to the...

77 FR 1973 - Petition for Exemption From the Vehicle Theft Prevention Standard; Fuji Heavy Industries U.S.A...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-12

... description and diagram of the identity, design and location of the components of the antitheft device for the... the antitheft device and the immobilization features are constructed and designed within the vehicle's... test. Additionally, FUSA stated that since the immobilization features are designed and constructed...

21 CFR 864.6700 - Erythrocyte sedimentation rate test.

Code of Federal Regulations, 2010 CFR

2010-04-01

... sedimentation rate test. (a) Identification. An erythrocyte sedimentation rate test is a device that measures the length of time required for the red cells in a blood sample to fall a specified distance or a... device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

21 CFR 864.6700 - Erythrocyte sedimentation rate test.

Code of Federal Regulations, 2014 CFR

2014-04-01

... sedimentation rate test. (a) Identification. An erythrocyte sedimentation rate test is a device that measures the length of time required for the red cells in a blood sample to fall a specified distance or a... device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

21 CFR 864.6700 - Erythrocyte sedimentation rate test.

Code of Federal Regulations, 2012 CFR

2012-04-01

... sedimentation rate test. (a) Identification. An erythrocyte sedimentation rate test is a device that measures the length of time required for the red cells in a blood sample to fall a specified distance or a... device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

21 CFR 864.6700 - Erythrocyte sedimentation rate test.

Code of Federal Regulations, 2011 CFR

2011-04-01

... sedimentation rate test. (a) Identification. An erythrocyte sedimentation rate test is a device that measures the length of time required for the red cells in a blood sample to fall a specified distance or a... device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

21 CFR 864.6700 - Erythrocyte sedimentation rate test.

Code of Federal Regulations, 2013 CFR

2013-04-01

... sedimentation rate test. (a) Identification. An erythrocyte sedimentation rate test is a device that measures the length of time required for the red cells in a blood sample to fall a specified distance or a... device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

21 CFR 862.1255 - 2,3-Diphosphoglyceric acid test system.

Code of Federal Regulations, 2013 CFR

2013-04-01

... acid test system is a device intended to measure 2,3-diphosphoglyceric acid (2,3-DPG) in erythrocytes (red blood cells). Measurements of 2,3-diphosphoglyceric acid are used in the diagnosis and treatment... the quality of stored blood. (b) Classification. Class I (general controls). The device is exempt from...

21 CFR 812.42 - FDA and IRB approval.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both...

21 CFR 812.42 - FDA and IRB approval.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both...

21 CFR 812.42 - FDA and IRB approval.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both...

21 CFR 812.42 - FDA and IRB approval.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both...

21 CFR 812.42 - FDA and IRB approval.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both...

75 FR 39263 - Guidance for Humanitarian Device Exemption Holders, Institutional Review Boards, Clinical...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-08

..., and Consumer Assistance (DSMICA), Center for Devices and Radiological Health (CDRH), Food and Drug... label to assist that office in processing your request, or fax your request to CDRH at 301-847-8149. The... the guidance you are requesting. A search capability for all CDRH guidance documents is available at...

Long Duration Exposure Facility (LDEF) attitude measurements of the interplanetary dust experiment

NASA Technical Reports Server (NTRS)

Kassel, Philip C., Jr.; Singer, S. Fred; Mulholland, J. Derral; Oliver, John P.; Weinberg, Jerry L.; Cooke, William J.; Wortman, Jim J.; Motley, William R., III

1992-01-01

The Long Duration Exposure Facility (LDEF) Interplanetary Dust Experiment (IDE) was unique in providing a time history of impacts of micron-sized particles on six orthogonal faces of LDEF during the first year in orbit. The value of this time resolved data depended on and was enhanced by the proper operation of some basic LDEF systems. Thus, the value of the data is greatly enhanced when the location and orientation of LDEF is known for each time of impact. The location and velocity of LDEF as a function of time can be calculated from the 'two-line elements' published by GSFC during the first year of the LDEF mission. The attitude of LDEF was passively stabilized in a gravity-gradient mode and a magnetically anchored viscous damper was used to dissipate roll, pitch, and yaw motions. Finally, the IDE used a standard LDEF Experiment Power and Data System (EPDS) to collect and store data and also to provide a crystal derived clock pulse (1 count every 13.1072 seconds) for all IDE time measurements. All that remained for the IDE was to provide a system to calibrate the clock, eliminating accumulative errors, and also verify the attitude of LDEF. The IDE used solar cells on six orthogonal faces to observe the LDEF sunrise and provide data about the LDEF attitude. The data was recorded by the EPDS about 10 times per day for the first 345 days of the LDEF mission. This data consist of the number of IDE counts since the last LDEF sunrise and the status of the six solar cells (light or dark) at the time of the last IDE count. The EPDS determined the time that data was recorded and includes, with each record, the master EPDS clock counter (1 count every 1.6384 seconds) that provided the range and resolution for time measurements. The IDE solar cells provided data for an excellent clock calibration, meeting their primary purpose, and the time resolved LDEF attitude measurements that can be gleaned from this data are presented.

Capacitive Behavior of Single Gallium Oxide Nanobelt

PubMed Central

Cai, Haitao; Liu, Hang; Zhu, Huichao; Shao, Pai; Hou, Changmin

2015-01-01

In this research, monocrystalline gallium oxide (Ga2O3) nanobelts were synthesized through oxidation of metal gallium at high temperature. An electronic device, based on an individual Ga2O3 nanobelt on Pt interdigital electrodes (IDEs), was fabricated to investigate the electrical characteristics of the Ga2O3 nanobelt in a dry atmosphere at room temperature. The current-voltage (I-V) and I/V-t characteristics show the capacitive behavior of the Ga2O3 nanobelt, indicating the existence of capacitive elements in the Pt/Ga2O3/Pt structure. PMID:28793506

Gemcitabine and Nucleos(t)ide Synthesis Inhibitors Are Broad-Spectrum Antiviral Drugs that Activate Innate Immunity.

PubMed

Shin, Hye Jin; Kim, Chonsaeng; Cho, Sungchan

2018-04-20

Nucleoside analogs have been frequently identified as antiviral agents. In recent years, gemcitabine, a cytidine analog in clinical use for the treatment of many solid tumors, was also shown to have antiviral activity against a broad range of viruses. Nucleoside analogs generally interfere with cellular nucleos(t)ide synthesis pathways, resulting in the depletion or imbalance of (d)NTP pools. Intriguingly, a few recent reports have shown that some nucleoside analogs, including gemcitabine, activated innate immunity, inducing the expression of interferon-stimulated genes, through nucleos(t)ide synthesis inhibition. The precise crosstalk between these two independent processes remains to be determined. Nonetheless, we summarize the current knowledge of nucleos(t)ide synthesis inhibition-related innate immunity and propose it as a newly emerging antiviral mechanism of nucleoside analogs.

Multiple allosteric sites are involved in the modulation of insulin-degrading-enzyme activity by somatostatin.

PubMed

Tundo, Grazia R; Di Muzio, Elena; Ciaccio, Chiara; Sbardella, Diego; Di Pierro, Donato; Polticelli, Fabio; Coletta, Massimo; Marini, Stefano

2016-10-01

Somatostatin is a cyclic peptide, released in the gastrointestinal system and the central nervous system, where it is involved in the regulation of cognitive and sensory functions, motor activity and sleep. It is a substrate of insulin-degrading enzyme (IDE), as well as a modulator of its activity and expression. In the present study, we have investigated the modulatory role of somatostatin on IDE activity at 37 °C and pH 7.3 for various substrates [i.e. insulin, β-amyloid (Aβ) 1-40 and bradykinin], aiming to quantitatively characterize the correlation between the specific features of the substrates and the regulatory mechanism. Functional data indicate that somatostatin, in addition to the catalytic site of IDE (being a substrate), is also able to bind to two additional exosites, which play different roles according to the size of the substrate and its binding mode to the IDE catalytic cleft. In particular, one exosite, which displays high affinity for somatostatin, regulates only the interaction of IDE with larger substrates (such as insulin and Aβ 1-40 ) in a differing fashion according to their various modes of binding to the enzyme. A second exosite, which is involved in the regulation of enzymatic processing by IDE of all substrates investigated (including a 10-25 amino acid long amyloid-like peptide, bradykinin and somatostatin itself, which had been studied previously), probably acts through the alteration of an 'open-closed' equilibrium. © 2016 Federation of European Biochemical Societies.

Patient and Staff Perceptions of Intradialytic Exercise before and after Implementation: A Qualitative Study

PubMed Central

Young, Hannah M. L.; Hudson, Nicky; Clarke, Amy L.; Dungey, Maurice; Feehally, John; Burton, James O.; Smith, Alice C.

2015-01-01

Introduction Despite guidance and evidence for the beneficial effects of intradialytic exercise (IDE), such programmes are rarely adopted within practice and little is known about how they may best be sustained. The Theoretical Domains Framework (TDF) was used to guide the understanding of the barriers and facilitators to initial and ongoing IDE participation and to understand how these are influential at each stage. Materials and Methods Focus groups explored patient (n=24) and staff (n=9) perceptions of IDE prior to the introduction of a programme and, six months later, face to face semi-structured interviews captured exercising patients (n=11) and staffs’ (n=8) actual experiences. Data were collected at private and NHS haemodialysis units within the UK. All data were audio-recorded, translated where necessary, transcribed verbatim and subject to framework analysis. Results IDE initiation can be facilitated by addressing the pre-existing beliefs about IDE through the influence of peers (for patients) and training (for staff). Participation was sustained through the observation of positive outcomes and through social influences such as teamwork and collaboration. Despite this, environment and resource limitations remained the greatest barrier perceived by both groups. Conclusions Novel methods of staff training and patient education should enhance engagement. Programmes that clearly highlight the benefits of IDE should be more successful in the longer term. The barrier of staff workload needs to be addressed through specific guidance that includes recommendations on staffing levels, roles, training and skill mix. PMID:26068875

Long-term microparticle flux variability indicated by comparison of Interplanetary Dust Experiment (IDE) timed impacts for LDEF's first year in orbit with impact data for the entire 5.77-year orbital lifetime

NASA Technical Reports Server (NTRS)

Simon, Charles G.; Mulholland, J. Derral; Oliver, John P.; Cooke, William J.; Kassel, Philip C., Jr.

1993-01-01

The electronic sensors of the Interplanetary Dust Experiment (IDE) recorded precise impact times and approximate directions for submicron to approximately 100 micron size particles on all six primary sides of the spacecraft for the first 346 days of the LDEF orbital mission. Previously-reported analyses of the timed impact data have established their spatio-temporal features, including the demonstration that a preponderance of the particles in this regime are orbital debris and that a large fraction of the debris particles are encountered in megameter-size clouds. Short-term fluxes within such clouds can rise several orders of magnitude above the long-term average. These unexpectedly large short-term variations in debris flux raise the question of how representative an indication of the multi-year average flux is given by the nearly one year of timed data. One of the goals of the IDE was to conduct an optical survey of impact sites on detectors that remained active during the entire LDEF mission, to obtain full-mission fluxes. We present here the comparisons and contrasts among the new IDE optical survey impact data, the IDE first-year timed impact data, and impact data from other LDEF micrometeoroid and debris experiments. The following observations are reported: (1) the 5.77 year long-term integrated microparticle impact fluxes recorded by IDE detectors matched the integrated impact fluxes measured by other LDEF investigators for the same period; (2) IDE integrated microparticle impact fluxes varied by factors from 0.5 to 8.3 for LDEF days 1-346, 347-2106 and 1-2106 (5.77 years) on rows 3 (trailing edge, or West), 6 (South side), 12 (North side), and the Earth and Space ends; and (3) IDE integrated microparticle impact fluxes varied less than 3 percent for LDEF days 1-346, 347-2106 and 1-2106 (5.77 years) on row 9 (leading edge, or East). These results give further evidence of the accuracy and internal consistency of the recorded IDE impact data. This leads to the further conclusion that the utility of long-term ratios for impacts on various sides of a stabilized satellite in low Earth orbit (LEO) is extremely limited. These observations and their consequences highlight the need for continuous, real time monitoring of the dynamic microparticle environment in LEO.

21 CFR 864.3300 - Cytocentrifuge.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) Identification. A cytocentrifuge is a centrifuge used to concentrate cells from biological cell suspensions (e.g...) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...

21 CFR 864.3300 - Cytocentrifuge.

Code of Federal Regulations, 2011 CFR

2011-04-01

...) Identification. A cytocentrifuge is a centrifuge used to concentrate cells from biological cell suspensions (e.g...) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...

Structure–activity relationships of imidazole-derived 2-[N-carbamoylmethyl-alkylamino]acetic acids, dual binders of human insulin-degrading enzyme

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

Charton, Julie; Gauriot, Marion; Totobenazara, Jane

Insulin degrading enzyme (IDE) is a zinc metalloprotease that degrades small amyloid peptides such as amyloid-â and insulin. So far the dearth of IDE-specific pharmacological inhibitors impacts the understanding of its role in the physiopathology of Alzheimer's disease, amyloid-â clearance, and its validation as a potential therapeutic target. Hit 1 was previously discovered by high-throughput screening. Here we describe the structure-activity study, that required the synthesis of 48 analogues. We found that while the carboxylic acid, the imidazole and the tertiary amine were critical for activity, the methyl ester was successfully optimized to an amide or a 1,2,4-oxadiazole. Along withmore » improving their activity, compounds were optimized for solubility, lipophilicity and stability in plasma and microsomes. The docking or co-crystallization of some compounds at the exosite or the catalytic site of IDE provided the structural basis for IDE inhibition. The pharmacokinetic properties of best compounds 44 and 46 were measured in vivo. As a result, 44 (BDM43079) and its methyl ester precursor 48 (BDM43124) are useful chemical probes for the exploration of IDE's role.« less

Characterization of Piezoresistive PEDOT:PSS Pressure Sensors with Inter-Digitated and Cross-Point Electrode Structures

PubMed Central

Wang, Jer-Chyi; Karmakar, Rajat Subhra; Lu, Yu-Jen; Huang, Chiung-Yin; Wei, Kuo-Chen

2015-01-01

The piezoresistive characteristics of poly(3,4-ethylenedioxythiophene):polystyrene sulfonate (PEDOT:PSS) pressure sensors with inter-digitated (IDE) and cross-point electrode (CPE) structures have been investigated. A small variation of the resistance of the pressure sensors with IDE without bottom indium-tin-oxide (b-ITO) film and with CPE structures was observed owing to the single carrier-conducting pathway. For the IDE pressure sensors with b-ITO, the piezoresistive characteristics at low and high pressure were similar to those of the pressure sensors with IDE without b-ITO and with CPE structures, respectively, leading to increased piezoresistive pressure sensitivity as the PEDOT:PSS film thickness decreased. A maximum sensitivity of more than 42 kΩ/Pa was achieved. When the normal pressure was applied, the increased number of conducting points or the reduced distance between the PEDOT oligomers within the PEDOT:PSS film resulted in a decrease of the resistance. The piezoresistive pressure sensors with a single carrier-conducting pathway, i.e., IDE without b-ITO and CPE structures, exhibited a small relaxation time and a superior reversible operation, which can be advantageous for fast piezoresistive response applications. PMID:25569756

Characterization of piezoresistive PEDOT:PSS pressure sensors with inter-digitated and cross-point electrode structures.

PubMed

Wang, Jer-Chyi; Karmakar, Rajat Subhra; Lu, Yu-Jen; Huang, Chiung-Yin; Wei, Kuo-Chen

2015-01-05

The piezoresistive characteristics of poly(3,4-ethylenedioxythiophene):polystyrene sulfonate (PEDOT:PSS) pressure sensors with inter-digitated (IDE) and cross-point electrode (CPE) structures have been investigated. A small variation of the resistance of the pressure sensors with IDE without bottom indium-tin-oxide (b-ITO) film and with CPE structures was observed owing to the single carrier-conducting pathway. For the IDE pressure sensors with b-ITO, the piezoresistive characteristics at low and high pressure were similar to those of the pressure sensors with IDE without b-ITO and with CPE structures, respectively, leading to increased piezoresistive pressure sensitivity as the PEDOT:PSS film thickness decreased. A maximum sensitivity of more than 42 kΩ/Pa was achieved. When the normal pressure was applied, the increased number of conducting points or the reduced distance between the PEDOT oligomers within the PEDOT:PSS film resulted in a decrease of the resistance. The piezoresistive pressure sensors with a single carrier-conducting pathway, i.e., IDE without b-ITO and CPE structures, exhibited a small relaxation time and a superior reversible operation, which can be advantageous for fast piezoresistive response applications.

Analysis of Interplanetary Dust Experiment Detectors and Other Witness Plates

NASA Technical Reports Server (NTRS)

Griffis, D. P.; Wortman, J. J.

1992-01-01

The development of analytical procedures for identifying the chemical composition of residue from impacts that occurred on the Interplanetary Dust Experiment (IDE) detectors during the flight of Long Duration Exposure Facility (LDEF) and the carrying out of actual analysis on IDE detectors and other witness plates are discussed. Two papers on the following topics are presented: (1) experimental analysis of hypervelocity microparticle impact sites on IDE sensor surfaces; and (2) contaminant interfaces with secondary Ion Mass Spectrometer (SIMS) analysis of microparticle impactor residues on LDEF surfaces.

77 FR 25209 - Environmental Assessment and Finding of No Significant Impact for Exemption Request for...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-27

... sealed source must either identify the source or device by manufacturer and model number as registered in...., Model Nos. 1862, 1864, and 1866 manual brachytherapy sources for medical uses authorized under the... that do not have an approved Sealed Source and Device Registry (SSDR). The NRC has determined that the...

75 FR 31837 - Petition for Exemption From the Vehicle Theft Prevention Standard; Mercedes-Benz

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-04

... agency comparing its proposed device to antitheft devices already installed in the Aston Martin Vantage... effective in contributing to a 63.5% reduction in the theft rate for the Aston Martin Vantage Line... Martin Vantage vehicle line and 0.6784 for the MY 2007. MBUSA also referenced theft data published by the...

21 CFR 882.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 882.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 890.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 888.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 888.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 870.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 886.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 886.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 892.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 870.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 888.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 892.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 882.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 886.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 870.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 890.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 886.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 892.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 882.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 870.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 890.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 872.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 868.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 868.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 872.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 868.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 888.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 890.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 868.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 892.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

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...

40 CFR 142.57 - Bottled water, point-of-use, and point-of-entry devices.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 23 2014-07-01 2014-07-01 false Bottled water, point-of-use, and point-of-entry devices. 142.57 Section 142.57 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS (CONTINUED) NATIONAL PRIMARY DRINKING WATER REGULATIONS IMPLEMENTATION Exemptions Issued by the Administrator § 142.57...

16 CFR 1500.88 - Exemptions from lead limits under section 101 of the Consumer Product Safety Improvement Act for...

Code of Federal Regulations, 2010 CFR

2010-01-01

... 101 of the Consumer Product Safety Improvement Act for certain electronic devices. 1500.88 Section... from lead limits under section 101 of the Consumer Product Safety Improvement Act for certain electronic devices. (a) The Consumer Product Safety Improvement Act (CPSIA) provides for specific lead limits...

21 CFR 862.1560 - Urinary phenylketones (nonquantitative) test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... and treatment of congenital phenylketonuria which, if untreated, may cause mental retardation. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in...

21 CFR 892.1910 - Radiographic grid.

Code of Federal Regulations, 2012 CFR

2012-04-01

... placed between the patient and the image receptor to reduce the amount of scattered radiation reaching the image receptor. (b) Classification. Class I (general controls). The device is exempt from the...

21 CFR 892.1910 - Radiographic grid.

Code of Federal Regulations, 2011 CFR

2011-04-01

... placed between the patient and the image receptor to reduce the amount of scattered radiation reaching the image receptor. (b) Classification. Class I (general controls). The device is exempt from the...

21 CFR 892.1910 - Radiographic grid.

Code of Federal Regulations, 2014 CFR

2014-04-01

... placed between the patient and the image receptor to reduce the amount of scattered radiation reaching the image receptor. (b) Classification. Class I (general controls). The device is exempt from the...

21 CFR 892.1910 - Radiographic grid.

Code of Federal Regulations, 2013 CFR

2013-04-01

... placed between the patient and the image receptor to reduce the amount of scattered radiation reaching the image receptor. (b) Classification. Class I (general controls). The device is exempt from the...

21 CFR 872.3220 - Facebow.

Code of Federal Regulations, 2010 CFR

2010-04-01

... for use in denture fabrication to determine the spatial relationship between the upper and lower jaws.... Class I (general controls). The device is exempt from the premarket notification procedures in subpart E...

21 CFR 880.5475 - Jet lavage.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., and a means of propelling the fluid through the tubing, such as an electric roller pump. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in...

21 CFR 880.5475 - Jet lavage.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., and a means of propelling the fluid through the tubing, such as an electric roller pump. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in...

21 CFR 886.3800 - Scleral shell.

Code of Federal Regulations, 2012 CFR

2012-04-01

... and proximal-cornea sclera for cosmetic or reconstructive purposes. An artificial eye is usually... controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

21 CFR 886.3800 - Scleral shell.

Code of Federal Regulations, 2014 CFR

2014-04-01

... and proximal-cornea sclera for cosmetic or reconstructive purposes. An artificial eye is usually... controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

21 CFR 886.3800 - Scleral shell.

Code of Federal Regulations, 2013 CFR

2013-04-01

... and proximal-cornea sclera for cosmetic or reconstructive purposes. An artificial eye is usually... controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

21 CFR 866.5490 - Hemopexin immunological test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... diagnosis of various hematologic disorders, such as hemolytic anemia (anemia due to shortened in vivo... span) and sickle cell anemia. (b) Classification. Class II (special controls). The device is exempt...

77 FR 1782 - Petition for Exemption; Summary of Petition Received

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-11

... any personal information you provide. Using the search function of our docket web site, anyone can... systems without giving approval for automatic activation devices (AAD). Parachute Labs provides...

21 CFR 874.1800 - Air or water caloric stimulator.

Code of Federal Regulations, 2010 CFR

2010-04-01

... vestibular function testing of a patient's body balance system. The vestibular stimulation of the...) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in...

[Double J stent removal's cost estimate using a re-sterilizable fibroscope in a French private structure].

PubMed

Almeras, C; Loison, G; Tollon, C; Gautier, J-R; Badoc, C; Cid, E; Sabatier, R; Zanoun, L; Brudo, L

2017-12-01

In front of the arrival of new devices intended to simplify the removal of double J stent, it poses the problem of the knowledge of the real cost of such an ablation under the current conditions of realization. This is a monocentric economic evaluation of cost and remuneration needed data-gathering of quotation (CCAM, GHS/SE, …), estimate of the associated costs of wear and damping of the endoscopic equipments (endoscopes, cables, …), estimate of the cost of sterilization, estimate of the associated costs to the intervention of staff (Auxiliary nurse [AS] and Nurse [IDE]) with timing of the various tasks. Quotation CCAM JCGE004 (48€) gives access to fixed price SE1 (73.71€ for private clinic, and 75.89€ for public institution) without hospitalization nor anaesthesia. The costs were reported to an act of single double J removal. Concerning the equipments: 4.42€HT for the fibroscopes, graspers, cable and light. The costs of sterilization were: 17.95€HT. The timed workforce's costs were: 7.61-9.51€ for AS and 9.92-10.84€ for IDE. The cost of consumable was about 1.37 €HT, by excluding the common base from the extractions (1.876€HT). The total costs in France in 2016 were thus about 47.4 to 50.496€ including all taxes. This estimate will be used certainly for reflection on the investments and the future studies of the economic impact of the new devices of extraction, by correlating it of course with the various maintenance contracts from each institution. 4. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Implications of formulation design on lipid-based nanostructured carrier system for drug delivery to brain.

PubMed

Salunkhe, Sachin S; Bhatia, Neela M; Bhatia, Manish S

2016-05-01

The aim of present investigation was to formulate and develop lipid-based nanostructured carriers (NLCs) containing Idebenone (IDE) for delivery to brain. Attempts have been made to evaluate IDE NLCs for its pharmacokinetic and pharmacodynamic profile through the objective of enhancement in bioavailability and effectivity of drug. Nanoprecipitation technique was used for development of drug loaded NLCs. The components solid lipid Precirol ATO 5, oil Miglyol 840, surfactants Tween 80 and Labrasol have been screened out for formulation development by consideration of preformulation parameters including solubility, Required Hydrophilic lipophilic balance (HLB) of lipids and stability study. Developed IDE NLCs were subjected for particle size, zeta potential, entrapment efficiency (%EE), crystallographic investigation, transmission electron microscopy, in vitro drug release, pharmacokinetics, in vivo and stability study. Formulation under investigation has particle size 174.1 ± 2.6 nm, zeta potential -18.65 ± 1.13 mV and% EE 90.68 ± 2.90. Crystallographic studies exemplified for partial amorphization of IDE by molecularly dispersion within lipid crust. IDE NLCs showed drug release 93.56 ± 0.39% at end of 24 h by following Higuchi model which necessitates for appropriate drug delivery with enhancement in bioavailability of drug by 4.6-fold in plasma and 2.8-fold in brain over plain drug loaded aqueous dispersions. In vivo studies revealed that effect of drug was enhanced by prepared lipid nanocarriers. IDE lipid-based nanostructured carriers could have potential for efficient drug delivery to brain with enhancement in bioavailability of drug over the conventional formulations.

Customizing the management of chronic hepatitis B virus infection.

PubMed

Gish, Robert G; Perrillo, Robert P; Jacobson, Ira M

2007-08-01

As of October 2006, 6 medications are approved in the United States for the management of chronic hepatitis B virus (HBV) infection: 2 formulations of interferon and 4 oral nucleos(t)ide analogues. For the treating practitioner, tailoring the pharmaceutical regimen according to patient features and clinical circumstances can be a challenge. First-line therapeutic regimens for the management of HBV infection include monotherapy with a U.S. Food and Drug Administration-approved agent that has potent on-treatment viral response and low rates of resistance; in the future, these regimens may include a combination of more than one nucleos(t)ide analogue or a combination of a nucleos(t)ide analogue and pegylated interferon. The oral nucleos(t)ide analogues are generally better tolerated than interferon; however, they can be expensive when administered for lengthy periods and can also lead to medication resistance. Lamivudine, the first approved nucleoside analogue for the treatment of HBV infection, has a very high resistance profile; in fact, lamivudine exposure increases viral resistance to other commercially available nucleos(t)ide analogues: entecavir, telbivudine, and adefovir. For these reasons, the 2007 American Association for the Study of Liver Diseases (AASLD) guidelines no longer recommend lamivudine as first-line therapy for the management of HBV infection. A satellite symposium conducted during the 57th Annual Meeting of the AASLD in Boston, Massachusetts, presented approaches to customizing the management of chronic HBV infection. The presentation highlighted recent findings suggesting that early, profound, and sustained viral suppression improves the probability of sustained virologic response and reduces the likelihood of nucleos(t)ide resistance.

Cost effectiveness of tenofovir disoproxil fumarate for the treatment of chronic hepatitis B from a Canadian public payer perspective.

PubMed

Dakin, Helen; Sherman, Morris; Fung, Scott; Fidler, Carrie; Bentley, Anthony

2011-12-01

Previous research has demonstrated that tenofovir disoproxil fumarate (DF) is the most cost-effective nucleos(t)ide treatment for chronic hepatitis B (CHB) in the UK, Spain, Italy and France. However, to our knowledge, no published studies have yet evaluated the cost effectiveness of any treatments for CHB in a Canadian setting, where relative prices and management of CHB differ from those in Europe. Our objective was to determine the cost effectiveness of tenofovir DF compared with other nucleos(t)ide therapies licensed for CHB in Canada from the perspective of publicly funded healthcare payers. A Markov model was used to calculate the costs and benefits of nucleos(t)ide therapy in three groups of patients with hepatitis B e antigen (HBeAg)-positive and -negative CHB: nucleos(t)ide-naive patients without cirrhosis; nucleos(t)ide-naive patients with compensated cirrhosis; and lamivudine-resistant patients. Disease progression was modelled as annual transitions between 18 disease states. Transition probabilities, quality of life and costs were based on published studies. Health benefits were measured in QALYs. The reference year for costs was 2007 and costs and outcomes were discounted at 5% per annum. First-line tenofovir DF was the most effective nucleos(t)ide strategy for managing CHB, generating 6.85-9.39 QALYs per patient. First-line tenofovir DF was also the most cost-effective strategy in all patient subgroups investigated, costing between $Can43,758 and $Can48,015 per QALY gained compared with lamivudine then tenofovir. First-line tenofovir DF strongly dominated first-line entecavir. Giving tenofovir DF monotherapy immediately after lamivudine resistance developed was less costly and more effective than any other active treatment strategy investigated for lamivudine-resistant CHB, including second-line use of adefovir or adefovir + lamivudine. Probabilistic sensitivity analysis demonstrated 50% confidence that first-line tenofovir DF is the most cost-effective nucleos(t)ide strategy for treatment-naive patients with CHB, at a $Can50,000 per QALY threshold, and confirmed that first-line tenofovir DF has the highest expected net benefits. First-line tenofovir DF appears to be the most cost-effective nucleos(t)ide treatment for both cirrhotic and non-cirrhotic CHB patients in Canada, providing that society is willing to pay at least $Can48,015 per QALY gained, although sensitivity analyses highlighted uncertainty around the results.

Retrospective epidemiological study of canine epilepsy in Japan using the International Veterinary Epilepsy Task Force classification 2015 (2003-2013): etiological distribution, risk factors, survival time, and lifespan.

PubMed

Hamamoto, Yuji; Hasegawa, Daisuke; Mizoguchi, Shunta; Yu, Yoshihiko; Wada, Masae; Kuwabara, Takayuki; Fujiwara-Igarashi, Aki; Fujita, Michio

2016-11-09

Epilepsy is the most common neurological disease in veterinary practice. However, contrary to human medicine, epilepsy classification in veterinary medicine had not been clearly defined until recently. A number of reports on canine epilepsy have been published, reflecting in part updated proposals from the human epilepsy organization, the International League Against Epilepsy. In 2015, the International Veterinary Epilepsy Task Force (IVETF) published a consensus report on the classification and definition of canine epilepsy. The purpose of this retrospective study was to investigate the etiological distribution, survival time of dogs with idiopathic epilepsy (IdE) and structural epilepsy (StE), and risk factors for survival time, according to the recently published IVETF classification. We investigated canine cases with epilepsy that were referred to our teaching hospital in Japan during the past 10 years, and which encompassed a different breed population from Western countries. A total of 358 dogs with epilepsy satisfied our etiological study criteria. Of these, 172 dogs (48 %) were classified as IdE and 76 dogs (21 %) as StE. Of these dogs, 100 dogs (consisting of 65 with IdE and 35 with StE) were included in our survival study. Median survival time from the initial epileptic seizure in dogs with IdE and StE was 10.4 and 4.5 years, respectively. Median lifespan of dogs with IdE and StE was 13.5 and 10.9 years, respectively. Multivariable analysis demonstrated that risk factors for survival time in IdE were high seizure frequency (≥0.3 seizures/month) and focal epileptic seizures. Focal epileptic seizures were identified as a risk factor for survival time in IdE. Clinicians should carefully differentiate seizure type as it is difficult to identify focal epileptic seizures. With good seizure control, dogs with IdE can survive for nearly the same lifespan as the general dog population. Our results using the IVETF classification are similar to previous studies, although some features were noted in our Japanese canine population (which was composed of mainly small-breed dogs), including a longer lifespan in dogs with epilepsy and a larger percentage of meningoencephalomyelitis of unknown origin in dogs with StE.

21 CFR 872.3730 - Pantograph.

Code of Federal Regulations, 2011 CFR

2011-04-01

... and, as the patient's mouth opens, the pen records on graph paper the angle between the upper and the lower jaw. (b) Classification. Class I (general controls). The device is exempt from the premarket...

Association between polymorphisms of the insulin-degrading enzyme gene and late-onset Alzheimer disease.

PubMed

Wang, Shitao; He, Feiyan; Wang, Ying

2015-06-01

The insulin-degrading enzyme (IDE) gene is a strong positional and biological candidate for late-onset Alzheimer disease (LOAD) susceptibility, with recent studies independently demonstrating an association between IDE gene variants and LOAD. However, previous data have been controversial. To investigate the relationship between IDE gene polymorphisms and LOAD risk, a case-control association study of 406 Han Chinese participants in Xinjiang, China, was undertaken. The LOAD and control groups consisted of 202 and 204 participants, respectively. The single-nucleotide polymorphisms rs1887922 and rs1999764 of the IDE gene were linked to LOAD incidence. The presence of the CT+CC genotype of rs1999764 had a protective effect compared to the TT genotype (adjusted P=.0001; odds ratio [OR]=0.226; 95% confidence interval [CI]=0.116-0.441), while the CT+CC genotype of rs1887922 was associated with increased LOAD risk (adjusted P=.0001; OR=3.640; 95% CI=1.889-7.016). Moreover, the effects of rs1887922 and rs1999764 were associated with LOAD risk independent of the apolipoprotein E ∊4 polymorphism and were more significant in men and women, respectively. These results demonstrate that the polymorphisms rs1887922 and rs1999764 of the IDE gene are associated with LOAD susceptibility in the Xinjiang Han population. © The Author(s) 2014.

21 CFR 868.1575 - Gas collection vessel.

Code of Federal Regulations, 2012 CFR

2012-04-01

... for subsequent analysis. It does not include a sampling pump. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

21 CFR 876.5160 - Urological clamp for males.

Code of Federal Regulations, 2010 CFR

2010-04-01

... temporarily. It is an external clamp. (b) Classification. Class I (general controls). Except when intended for internal use or use on females, the device is exempt from the premarket notification procedures in subpart...

78 FR 56839 - Compatibility of Generally Licensed and Exempt Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-16

... 20852. FOR FURTHER INFORMATION CONTACT: Solomon Sahle, Office of Federal and State Materials and...-415- 3781, email: Solomon[email protected] . SUPPLEMENTARY INFORMATION: I. The Petition Section 2.802 of...

21 CFR 886.4070 - Powered corneal burr.

Code of Federal Regulations, 2013 CFR

2013-04-01

... to remove rust rings from the cornea of the eye. (b) Classification. Class I (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in...

21 CFR 886.4070 - Powered corneal burr.

Code of Federal Regulations, 2011 CFR

2011-04-01

... to remove rust rings from the cornea of the eye. (b) Classification. Class I (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in...

21 CFR 886.4070 - Powered corneal burr.

Code of Federal Regulations, 2014 CFR

2014-04-01

... to remove rust rings from the cornea of the eye. (b) Classification. Class I (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in...

21 CFR 886.4070 - Powered corneal burr.

Code of Federal Regulations, 2010 CFR

2010-04-01

... to remove rust rings from the cornea of the eye. (b) Classification. Class I (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in...

21 CFR 886.4070 - Powered corneal burr.

Code of Federal Regulations, 2012 CFR

2012-04-01

... to remove rust rings from the cornea of the eye. (b) Classification. Class I (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in...

75 FR 3154 - Children's Products Containing Lead; Exemptions for Certain Electronic Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-20

..., some calculators, and certain computers or similar electronic learning products. 3. Certain Lead...: (1) Lead blended into the glass of cathode ray tubes, electronic components, and fluorescent tubes...

21 CFR 874.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 874.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 874.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

21 CFR 874.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

Laboratory variables for assessing iron deficiency in REDS-II Iron Status Evaluation (RISE) blood donors

PubMed Central

Kiss, Joseph E.; Steele, Whitney R.; Wright, David J.; Mast, Alan E.; Carey, Patricia M.; Murphy, Edward L.; Gottschall, Jerry L.; Simon, Toby L.; Cable, Ritchard G.

2014-01-01

BACKGROUND Iron deficiency is common in regular blood donors. We evaluated the diagnostic sensitivity and specificity of red blood cell (RBC) hematology analyzer indices to assess iron status as a part of donor management. STUDY DESIGN AND METHODS A total of 1659 male and female donors from the Retrovirus Epidemiology Donor Study-II (REDS-II) Donor Iron Status Evaluation (RISE) study who were either first-time/reactivated (FT/ RA; no donations for 2 years) or frequent donors were recruited into a longitudinal study of regular donation of RBCs. Of these, 1002 donors returned 15 to 24 months later for a final assessment. Absent iron stores (AIS) was defined as plasma ferritin level of less than 12 µ.g/L. Logarithm of the ratio of soluble transferrin receptor to ferritin of at least 2.07 (≥97.5% in FT/RA males) was used to define iron-deficient erythropoiesis (IDE). Receiver operating characteristics analysis was performed to assess selected RBC indices (e.g., percentage of hypochromic mature RBCs, proportion of hypochromic mature RBCs [HYPOm], and hemoglobin [Hb] content of reticulocytes [CHr]) in identifying AIS and IDE. RESULTS HYPOm and CHr detected IDE with comparable sensitivity, 72% versus 69%, but differed in specificity: HYPOm 68% and CHr 53%. For detecting AIS, sensitivity was improved to 85% for HYPOm and 81% for CHr but specificity was reduced for both. Venous Hb had high specificity but poor sensitivity for IDE and AIS. A plasma ferritin level of less than 26.7 u.g/L was a good surrogate for assessing IDE. CONCLUSION RBC indices correlate with AIS and IDE and are more informative than Hb measurement, but lack sufficient sensitivity and specificity to be used as diagnostic tools in blood donors at risk for iron deficiency. PMID:23617531

Efficient programming of human eye conjunctiva-derived induced pluripotent stem (ECiPS) cells into definitive endoderm-like cells.

PubMed

Massumi, Mohammad; Hoveizi, Elham; Baktash, Parvaneh; Hooti, Abdollah; Ghazizadeh, Leili; Nadri, Samad; Pourasgari, Farzaneh; Hajarizadeh, Athena; Soleimani, Masoud; Nabiuni, Mohammad; Khorramizadeh, Mohammad R

2014-03-10

Due to pluripotency of induced pluripotent stem (iPS) cells, and the lack of immunological incompatibility and ethical issues, iPS cells have been considered as an invaluable cell source for future cell replacement therapy. This study was aimed first at establishment of novel iPS cells, ECiPS, which directly reprogrammed from human Eye Conjunctiva-derived Mesenchymal Stem Cells (EC-MSCs); second, comparing the inductive effects of Wnt3a/Activin A biomolecules to IDE1 small molecule in derivation of definitive endoderm (DE) from the ECiPS cells. To that end, first, the EC-MSCs were transduced by SOKM-expressing lentiviruses and characterized for endogenous expression of embryonic markers Then the established ECiPS cells were induced to DE formation by Wnt3a/Activin A or IDE1. Quantification of GSC, Sox17 and Foxa2 expression, as DE-specific markers, in both mRNA and protein levels revealed that induction of ECiPS cells by either Wnt3a/Activin A or IDE1 could enhance the expression level of the genes; however the levels of increase were higher in Wnt3a/Activin A induced ECiPS-EBs than IDE1 induced cells. Furthermore, the flow cytometry analyses showed no synergistic effect between Activin A and Wnt3a to derive DE-like cells from ECiPS cells. The comparative findings suggest that although both Wnt3a/Activin A signaling and IDE1 molecule could be used for differentiation of iPS into DE cells, the DE-inducing effect of Wnt3a/Activin A was statistically higher than IDE1. Copyright © 2014 Elsevier Inc. All rights reserved.

Laboratory variables for assessing iron deficiency in REDS-II Iron Status Evaluation (RISE) blood donors.

PubMed

Kiss, Joseph E; Steele, Whitney R; Wright, David J; Mast, Alan E; Carey, Patricia M; Murphy, Edward L; Gottschall, Jerry L; Simon, Toby L; Cable, Ritchard G

2013-11-01

Iron deficiency is common in regular blood donors. We evaluated the diagnostic sensitivity and specificity of red blood cell (RBC) hematology analyzer indices to assess iron status as a part of donor management. A total of 1659 male and female donors from the Retrovirus Epidemiology Donor Study-II (REDS-II) Donor Iron Status Evaluation (RISE) study who were either first-time/reactivated (FT/RA; no donations for 2 years) or frequent donors were recruited into a longitudinal study of regular donation of RBCs. Of these, 1002 donors returned 15 to 24 months later for a final assessment. Absent iron stores (AIS) was defined as plasma ferritin level of less than 12 μg/L. Logarithm of the ratio of soluble transferrin receptor to ferritin of at least 2.07 (≥97.5% in FT/RA males) was used to define iron-deficient erythropoiesis (IDE). Receiver operating characteristics analysis was performed to assess selected RBC indices (e.g., percentage of hypochromic mature RBCs, proportion of hypochromic mature RBCs [HYPOm], and hemoglobin [Hb] content of reticulocytes [CHr]) in identifying AIS and IDE. HYPOm and CHr detected IDE with comparable sensitivity, 72% versus 69%, but differed in specificity: HYPOm 68% and CHr 53%. For detecting AIS, sensitivity was improved to 85% for HYPOm and 81% for CHr but specificity was reduced for both. Venous Hb had high specificity but poor sensitivity for IDE and AIS. A plasma ferritin level of less than 26.7 μg/L was a good surrogate for assessing IDE. RBC indices correlate with AIS and IDE and are more informative than Hb measurement, but lack sufficient sensitivity and specificity to be used as diagnostic tools in blood donors at risk for iron deficiency. © 2013 American Association of Blood Banks.

Capacitance Variation Induced by Microfluidic Two-Phase Flow across Insulated Interdigital Electrodes in Lab-On-Chip Devices

PubMed Central

Dong, Tao; Barbosa, Cátia

2015-01-01

Microfluidic two-phase flow detection has attracted plenty of interest in various areas of biology, medicine and chemistry. This work presents a capacitive sensor using insulated interdigital electrodes (IDEs) to detect the presence of droplets in a microchannel. This droplet sensor is composed of a glass substrate, patterned gold electrodes and an insulation layer. A polydimethylsiloxane (PDMS) cover bonded to the multilayered structure forms a microchannel. Capacitance variation induced by the droplet passage was thoroughly investigated with both simulation and experimental work. Olive oil and deionized water were employed as the working fluids in the experiments to demonstrate the droplet sensor. The results show a good sensitivity of the droplet with the appropriate measurement connection. This capacitive droplet sensor is promising to be integrated into a lab-on-chip device for in situ monitoring/counting of droplets or bubbles. PMID:25629705

77 FR 65761 - Petition for Exemption; Summary of Petition Received

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-30

... an explosive or incendiary device; 6. The requirement for a designated location where a bomb or other... case of detonation (least risk bomb location); 7. The requirement that the passenger cabin be designed...

21 CFR 886.5820 - Closed-circuit television reading system.

Code of Federal Regulations, 2011 CFR

2011-04-01

... of a lens, video camera, and video monitor that is intended for use by a patient who has subnormal vision to magnify reading material. (b) Classification. Class I (general controls). The device is exempt...

21 CFR 888.4800 - Template for clinical use.

Code of Federal Regulations, 2011 CFR

2011-04-01

... cutting. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9. [52 FR...

47 CFR 15.205 - Restricted bands of operation.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Intentional Radiators § 15.205 Restricted bands of operation. (a) Except as shown in paragraph (d) of this... radiator. (d) The following devices are exempt from the requirements of this section: (1) Swept frequency...

47 CFR 15.103 - Exempted devices.

Code of Federal Regulations, 2011 CFR

2011-10-01

... exclusively as an electronic control or power system utilized by a public utility or in an industrial plant... circuit to convert the signal to the format required (e.g., an integrated circuit for analog to digital...

47 CFR 15.103 - Exempted devices.

Code of Federal Regulations, 2010 CFR

2010-10-01

... exclusively as an electronic control or power system utilized by a public utility or in an industrial plant... circuit to convert the signal to the format required (e.g., an integrated circuit for analog to digital...

47 CFR 15.103 - Exempted devices.

Code of Federal Regulations, 2013 CFR

2013-10-01

... exclusively as an electronic control or power system utilized by a public utility or in an industrial plant... circuit to convert the signal to the format required (e.g., an integrated circuit for analog to digital...

47 CFR 15.103 - Exempted devices.

Code of Federal Regulations, 2014 CFR

2014-10-01

... exclusively as an electronic control or power system utilized by a public utility or in an industrial plant... circuit to convert the signal to the format required (e.g., an integrated circuit for analog to digital...

47 CFR 15.103 - Exempted devices.

Code of Federal Regulations, 2012 CFR

2012-10-01

... exclusively as an electronic control or power system utilized by a public utility or in an industrial plant... circuit to convert the signal to the format required (e.g., an integrated circuit for analog to digital...

MollDE: a homology modeling framework you can click with.

PubMed

Canutescu, Adrian A; Dunbrack, Roland L

2005-06-15

Molecular Integrated Development Environment (MolIDE) is an integrated application designed to provide homology modeling tools and protocols under a uniform, user-friendly graphical interface. Its main purpose is to combine the most frequent modeling steps in a semi-automatic, interactive way, guiding the user from the target protein sequence to the final three-dimensional protein structure. The typical basic homology modeling process is composed of building sequence profiles of the target sequence family, secondary structure prediction, sequence alignment with PDB structures, assisted alignment editing, side-chain prediction and loop building. All of these steps are available through a graphical user interface. MolIDE's user-friendly and streamlined interactive modeling protocol allows the user to focus on the important modeling questions, hiding from the user the raw data generation and conversion steps. MolIDE was designed from the ground up as an open-source, cross-platform, extensible framework. This allows developers to integrate additional third-party programs to MolIDE. http://dunbrack.fccc.edu/molide/molide.php rl_dunbrack@fccc.edu.

Development of a Spanish version of the "Backache Index".

PubMed

Cuesta-Vargas, Antonio; Gonzaleaz-Sanchez, Manuel; Farasyn, Andre

2010-01-01

In routine clinical practice a physical examination should include an assessment of ability/function. The use of a scale or index in low back pain (LBP) is mainly used to categorize patients and to measure syndrome severity. For this reason we developed an easy and quick to perform standardised measuring procedure of impairment in patients with LBP without using inclinometers. The new "Backache Index" (BAI) is applied in order to help therapists, doctors, and surgeons perform physical examinations easily. The factor of presence or absence of pain with respect to different lumbar movements is elaborated for the patient with LBP, standing in an erect position. This resulted in outcome scores (0-3) for five impairment examinations of the trunk from which the sum of the scores gives the BAI (max. 15 points). The purpose of this study was to develop the linguistic adaptation and to explore the reliability of this new Backache Index translated in a Spanish version called "indice de Dolor de Espalda" or IDE, which can fulfil the existing need for a reliable routine examination in the clinical environment for Spanish speaking clinicians and patients. Two independent translations were made by two separate professional translators to Spanish. Both versions were compared and consensus resulted in a single translation. In a pain center patients were asked to participate in this project as volunteers. The exclusion criteria have been used in patients with LBP suffering of severe spinal pathology or having deseases. In total 46 patients (67% females, age = 52 ± 13 years) underwent the physical examination at the first session (IDE-1) and were retested without any treatment after 3 days (IDE-2). The two translations submitted by respective experts were identical and the final IDE was used in futher clinical examinations. The test-retest after 3 days of the same group revailed that the reliability for the 5 outcome scores was good (ICC ⩾ 0.73). No significant difference was found between IDE-1 (4.65 ± 4.15 ) and IDE-2 (4.72 ± 4.20) and the absolute reliability was perfect with an ICC=0.97. The IDE form facilitates a better diffusion under the Spanish speaking population, allowing it to maintain the degree of homogenenity and acceptance that the "Indice de Dolor de Espalda" or IDE has in clinical practice, helping to spread among the Hispanic world one of the objectives that the creator of this index raised when it was developed.

77 FR 51104 - Parts and Accessories Necessary for Safe Operation; Application for an Exemption From...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-23

... vehicles (CMVs). The Federal Motor Carrier Safety Regulations (FMCSRs) currently require antennas... the driver's field of view by devices mounted at the top of the windshield. Antennas, transponders and...

21 CFR 872.3910 - Backing and facing for an artificial tooth.

Code of Federal Regulations, 2010 CFR

2010-04-01

... use in fabrication of a fixed or removable dental appliance, such as a crown or bridge. The backing... is made of porcelain or plastic. (b) Classification. Class I (general controls). The device is exempt...

78 FR 4190 - Petition for Exemption; Summary of Petition Received

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-18

... Lines' 737-800 fleet, a placard was placed on the flight deck prohibiting use of WiFi devices from the... using the existing aircraft WiFi connection during the operational demonstration period of the research...

Early clinical results of a high-flexion, posterior-stabilized, mobile-bearing total knee arthroplasty: a US investigational device exemption trial.

PubMed

Scuderi, Giles R; Hedden, David R; Maltry, John A; Traina, Steven M; Sheinkop, Mitchell B; Hartzband, Mark A

2012-03-01

Between May 2001 and June 2004, 388 total knee arthroplasty cases were enrolled in a prospective, randomized, multicenter investigational device exemption trial. Patients received either the investigational high-flexion mobile-bearing knee or a fixed-bearing control. At 2 to 4 years of follow-up, results in 293 patients with degenerative joint disease were compared using Knee Society Assessment and Function scores, radiographic results, complications analysis, and survival estimates. The mobile-bearing and fixed-bearing groups demonstrated similar, significant improvement over preoperative assessments in Knee Scores, maximum flexion, and range of motion. One mobile-bearing arthroplasty required revision. Radiographic results were unremarkable, and implant-related complications were rare in both groups. At this early follow-up, the investigational high-flexion mobile-bearing knee and its fixed-bearing counterpart demonstrated comparable, effective performance. Copyright © 2012 Elsevier Inc. All rights reserved.

21 CFR 812.19 - Address for IDE correspondence.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Document Control Center (HFM-99), Center for Biologics Evaluation and Research, Food and Drug... Evaluation and Research, Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 20705-1266. (b... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Address for IDE correspondence. 812.19 Section 812...

The Scenario Analysis Tool Suite: A User’s Guide

DTIC Science & Technology

2009-01-01

be exported at any stage and continued manually. The free, open-source integrated development environment (IDE) NetBeans [14] was used in the creation...and Technology Organisation, Australia. 14. Sun Microsystems & CollabNet (2008) NetBeans IDE 6.0, http://wwwnetbeans.org. 15. Tri, N., Boswell, S

Delegations of authority and organization; Center for Devices and Radiological Health--FDA. Final rule.

PubMed

1994-06-17

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority relating to general redelegations of authority from the Associate Commissioner of Regulatory Affairs to certain FDA officials in the Center for Devices and Radiological Health (CDRH). The redelegation provides these officials with authority to grant or deny certain citizen petitions for exemption or variance from medical device tracking requirements. This action is being taken to facilitate expeditious handling of citizen petitions. FDA is also issuing a conforming amendment to the medical device tracking regulations to make the regulations consistent.

Solar-blind-ultraviolet extraordinary transmission for ultrasensitive photoconductive detector based on plasmonic subwavelength interdigital electrodes

NASA Astrophysics Data System (ADS)

Peng, Nan; Huang, Feng; Chu, Sheng; Chen, Hao

2016-12-01

The solar-blind-ultraviolet (SBUV) detection industry demands high sensitivity as well as easy processability for its semiconductor devices. Photoconductive detectors have the simplest structure. However, the electrodes covering the illuminated side cause optical shielding losses, resulting in a relatively low sensitivity of such devices. Through finite-difference time-domain (FDTD) simulation, we demonstrated that surface-plasmon-based enhanced SBUV transmission is achievable for Al interdigital electrodes (IDEs) with a period  ⩽200 nm and an interval  ⩾140 nm. Under this parameter setting, a larger interval and smaller period leads to further enhancement of SBUV transmission. Particularly, we have found that different possible dielectric environments, such as Ni insertion, Al oxidization, and MgF2 anti-oxidation, would not exert fatal effects on this enhancement. Besides, such an enhancement is maintained under the angle of incidence within 10°, which is large enough for practical SBUV detection. Our research reveals the feasibility of high sensitivity by a simple photoconductive device, showing profound significance for an applicable SBUV detector.

40 CFR 266.109 - Low risk waste exemption.

Code of Federal Regulations, 2012 CFR

2012-07-01

... of fuel fired to the device shall be fossil fuel, fuels derived from fossil fuel, tall oil, or, if... comparable to fossil fuel. Such fuels are termed “primary fuel” for purposes of this section. (Tall oil is a...

40 CFR 266.109 - Low risk waste exemption.

Code of Federal Regulations, 2014 CFR

2014-07-01

... of fuel fired to the device shall be fossil fuel, fuels derived from fossil fuel, tall oil, or, if... comparable to fossil fuel. Such fuels are termed “primary fuel” for purposes of this section. (Tall oil is a...

40 CFR 266.109 - Low risk waste exemption.

Code of Federal Regulations, 2011 CFR

2011-07-01

... of fuel fired to the device shall be fossil fuel, fuels derived from fossil fuel, tall oil, or, if... comparable to fossil fuel. Such fuels are termed “primary fuel” for purposes of this section. (Tall oil is a...

40 CFR 266.109 - Low risk waste exemption.

Code of Federal Regulations, 2010 CFR

2010-07-01

... of fuel fired to the device shall be fossil fuel, fuels derived from fossil fuel, tall oil, or, if... comparable to fossil fuel. Such fuels are termed “primary fuel” for purposes of this section. (Tall oil is a...

40 CFR 266.109 - Low risk waste exemption.

Code of Federal Regulations, 2013 CFR

2013-07-01

... of fuel fired to the device shall be fossil fuel, fuels derived from fossil fuel, tall oil, or, if... comparable to fossil fuel. Such fuels are termed “primary fuel” for purposes of this section. (Tall oil is a...

Insulin‐degrading enzyme is genetically associated with Alzheimer's disease in the Finnish population

PubMed Central

Vepsäläinen, Saila; Parkinson, Michele; Helisalmi, Seppo; Mannermaa, Arto; Soininen, Hilkka; Tanzi, Rudolph E; Bertram, Lars; Hiltunen, Mikko

2007-01-01

The gene for insulin‐degrading enzyme (IDE), which is located at chromosome 10q24, has been previously proposed as a candidate gene for late‐onset Alzheimer's disease (AD) based on its ability to degrade amyloid β‐protein. Genotyping of single nucleotide polymorphisms (SNPs) in the IDE gene in Finnish patients with AD and controls revealed SNPs rs4646953 and rs4646955 to be associated with AD, conferring an approximately two‐fold increased risk. Single locus findings were corroborated by the results obtained from haplotype analyses. This suggests that genetic alterations in or near the IDE gene may increase the risk for developing AD. PMID:17496198

Terabyte IDE RAID-5 Disk Arrays

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

David A. Sanders et al.

2003-09-30

High energy physics experiments are currently recording large amounts of data and in a few years will be recording prodigious quantities of data. New methods must be developed to handle this data and make analysis at universities possible. We examine some techniques that exploit recent developments in commodity hardware. We report on tests of redundant arrays of integrated drive electronics (IDE) disk drives for use in offline high energy physics data analysis. IDE redundant array of inexpensive disks (RAID) prices now are less than the cost per terabyte of million-dollar tape robots! The arrays can be scaled to sizes affordablemore » to institutions without robots and used when fast random access at low cost is important.« less

Large-Scale Dynamic Observation Planning for Unmanned Surface Vessels

DTIC Science & Technology

2007-06-01

programming language. In addition, the useful development software NetBeans IDE is free and makes the use of Java very user-friendly. 92...3. We implemented the greedy and 3PAA algorithms in Java using the NetBeans IDE version 5.5. 4. The test datasets were generated in MATLAB. 5

Carbon Nanotube Based Chemical Sensors for Space and Terrestrial Applications

NASA Technical Reports Server (NTRS)

Li, Jing; Lu, Yijiang

2009-01-01

A nanosensor technology has been developed using nanostructures, such as single walled carbon nanotubes (SWNTs), on a pair of interdigitated electrodes (IDE) processed with a silicon-based microfabrication and micromachining technique. The IDE fingers were fabricated using photolithography and thin film metallization techniques. Both in-situ growth of nanostructure materials and casting of the nanostructure dispersions were used to make chemical sensing devices. These sensors have been exposed to nitrogen dioxide, acetone, benzene, nitrotoluene, chlorine, and ammonia in the concentration range of ppm to ppb at room temperature. The electronic molecular sensing of carbon nanotubes in our sensor platform can be understood by intra- and inter-tube electron modulation in terms of charge transfer mechanisms. As a result of the charge transfer, the conductance of p-type or hole-richer SWNTs in air will change. Due to the large surface area, low surface energy barrier and high thermal and mechanical stability, nanostructured chemical sensors potentially can offer higher sensitivity, lower power consumption and better robustness than the state-of-the-art systems, which make them more attractive for defense and space applications. Combined with MEMS technology, light weight and compact size sensors can be made in wafer scale with low cost. Additionally, a wireless capability of such a sensor chip can be used for networked mobile and fixed-site detection and warning systems for military bases, facilities and battlefield areas.

Fingerprinting Desmosine-Containing Elastin Peptides

NASA Astrophysics Data System (ADS)

Schräder, Christoph U.; Heinz, Andrea; Majovsky, Petra; Schmelzer, Christian E. H.

2015-05-01

Elastin is a vital protein of the extracellular matrix of jawed vertebrates and provides elasticity to numerous tissues. It is secreted in the form of its soluble precursor tropoelastin, which is subsequently cross-linked in the course of the elastic fiber assembly. The process involves the formation of the two tetrafunctional amino acids desmosine (DES) and isodesmosine (IDES), which are unique to elastin. The resulting high degree of cross-linking confers remarkable properties, including mechanical integrity, insolubility, and long-term stability to the protein. These characteristics hinder the structural elucidation of mature elastin. However, MS2 data of linear and cross-linked peptides released by proteolysis can provide indirect insights into the structure of elastin. In this study, we performed energy-resolved collision-induced dissociation experiments of DES, IDES, their derivatives, and DES-/IDES-containing peptides to determine characteristic product ions. It was found that all investigated compounds yielded the same product ion clusters at elevated collision energies. Elemental composition determination using the exact masses of these ions revealed molecular formulas of the type CxHyN, suggesting that the pyridinium core of DES/IDES remains intact even at relatively high collision energies. The finding of these specific product ions enabled the development of a similarity-based scoring algorithm that was successfully applied on LC-MS/MS data of bovine elastin digests for the identification of DES-/IDES-cross-linked peptides. This approach facilitates the straightforward investigation of native cross-links in elastin.

Fingerprinting desmosine-containing elastin peptides.

PubMed

Schräder, Christoph U; Heinz, Andrea; Majovsky, Petra; Schmelzer, Christian E H

2015-05-01

Elastin is a vital protein of the extracellular matrix of jawed vertebrates and provides elasticity to numerous tissues. It is secreted in the form of its soluble precursor tropoelastin, which is subsequently cross-linked in the course of the elastic fiber assembly. The process involves the formation of the two tetrafunctional amino acids desmosine (DES) and isodesmosine (IDES), which are unique to elastin. The resulting high degree of cross-linking confers remarkable properties, including mechanical integrity, insolubility, and long-term stability to the protein. These characteristics hinder the structural elucidation of mature elastin. However, MS(2) data of linear and cross-linked peptides released by proteolysis can provide indirect insights into the structure of elastin. In this study, we performed energy-resolved collision-induced dissociation experiments of DES, IDES, their derivatives, and DES-/IDES-containing peptides to determine characteristic product ions. It was found that all investigated compounds yielded the same product ion clusters at elevated collision energies. Elemental composition determination using the exact masses of these ions revealed molecular formulas of the type CxHyN, suggesting that the pyridinium core of DES/IDES remains intact even at relatively high collision energies. The finding of these specific product ions enabled the development of a similarity-based scoring algorithm that was successfully applied on LC-MS/MS data of bovine elastin digests for the identification of DES-/IDES-cross-linked peptides. This approach facilitates the straightforward investigation of native cross-links in elastin.

Synthesis and Characterization of Stimuli-Responsive Star-Like Polypept(o)ides: Introducing Biodegradable PeptoStars.

PubMed

Holm, Regina; Weber, Benjamin; Heller, Philipp; Klinker, Kristina; Westmeier, Dana; Docter, Dominic; Stauber, Roland H; Barz, Matthias

2017-06-01

Star-like polymers are one of the smallest systems in the class of core crosslinked polymeric nanoparticles. This article reports on a versatile, straightforward synthesis of three-arm star-like polypept(o)ide (polysarcosine-block-polylysine) polymers, which are designed to be either stable or degradable at elevated levels of glutathione. Polypept(o)ides are a recently introduced class of polymers combining the stealth-like properties of the polypeptoid polysarcosine with the functionality of polypeptides, thus enabling the synthesis of materials completely based on endogenous amino acids. The star-like homo and block copolymers are synthesized by living nucleophilic ring opening polymerization of the corresponding N-carboxyanhydrides (NCAs) yielding polymeric stars with precise control over the degree of polymerization (X n = 25, 50, 100), Poisson-like molecular weight distributions, and low dispersities (Đ = 1.06-1.15). Star-like polypept(o)ides display a hydrodynamic radius of 5 nm (μ 2 < 0.05) as determined by dynamic light scattering (DLS). While star-like polysarcosines and polypept(o)ides based on disulfide containing initiators are stable in solution, degradation occurs at 100 × 10 -3 m glutathione concentration. The disulfide cleavage yields the respective polymeric arms, which possess Poisson-like molecular weight distributions and low dispersities (Đ = 1.05-1.12). Initial cellular uptake and toxicity studies reveal that PeptoStars are well tolerated by HeLa, HEK 293, and DC 2.4 cells. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Global Earth Observation System of Systems (GEOSS): Initial Actions to Enhance Data Sharing to Meet Societal Needs

NASA Astrophysics Data System (ADS)

Adang, T.

2006-05-01

Over 60 nations and 50 participating organizations are working to make the Global Earth Observation System of Systems (GEOSS) a reality. The U.S. contribution to GEOSS is the Integrated Earth Observation System (IEOS), with a vision of enabling a healthy public, economy and planet through an integrated, comprehensive, and sustained Earth observation system. The international Group on Earth Observations (GEO) and the U.S. Group on Earth Observations have developed strategic plans for both GEOSS and IEOS, respectively, and are now working the first phases of implementation. Many of these initial actions are data architecture related and are being addressed by architecture and data working groups from both organizations - the GEO Architecture and Data Committee and the USGEO Architecture and Data Management Working Group. NOAA has actively participated in both architecture groups and has taken internal action to better support GEOSS and IEOS implementation by establishing the Global Earth Observation Integrated Data Environment (GEO IDE). GEO IDE provides a "system of systems" framework for effective and efficient integration of NOAA's many quasi-independent systems, which individually address diverse mandates in such areas resource management, weather forecasting, safe navigation, disaster response, and coastal mapping among others. GEO IDE will have a services oriented architecture, allowing NOAA Line Offices to retain a high level of independence in many of their data management decisions, and encouraging innovation in pursuit of their missions. Through GEO IDE, NOAA partners (both internal and external) will participate in a well-ordered, standards-based data and information infrastructure that will allow users to easily locate, acquire, integrate and utilize NOAA data and information. This paper describes the initial progress being made by GEO and USGEO architecture and data working groups, a status report on GEO IDE development within NOAA, and an assessment of how GEO IDE can facilitate greater progress in GEOSS and IEOS development.

Gene expression levels as endophenotypes in genome-wide association studies of Alzheimer disease

PubMed Central

Zou, F.; Carrasquillo, M. M.; Pankratz, V. S.; Belbin, O.; Morgan, K.; Allen, M.; Wilcox, S. L.; Ma, L.; Walker, L. P.; Kouri, N.; Burgess, J. D.; Younkin, L. H.; Younkin, Samuel G.; Younkin, C. S.; Bisceglio, G. D.; Crook, J. E.; Dickson, D. W.; Petersen, R. C.; Graff-Radford, N.; Younkin, Steven G.; Ertekin-Taner, N.

2010-01-01

Background: Late-onset Alzheimer disease (LOAD) is a common disorder with a substantial genetic component. We postulate that many disease susceptibility variants act by altering gene expression levels. Methods: We measured messenger RNA (mRNA) expression levels of 12 LOAD candidate genes in the cerebella of 200 subjects with LOAD. Using the genotypes from our LOAD genome-wide association study for the cis-single nucleotide polymorphisms (SNPs) (n = 619) of these 12 LOAD candidate genes, we tested for associations with expression levels as endophenotypes. The strongest expression cis-SNP was tested for AD association in 7 independent case-control series (2,280 AD and 2,396 controls). Results: We identified 3 SNPs that associated significantly with IDE (insulin degrading enzyme) expression levels. A single copy of the minor allele for each significant SNP was associated with ∼twofold higher IDE expression levels. The most significant SNP, rs7910977, is 4.2 kb beyond the 3′ end of IDE. The association observed with this SNP was significant even at the genome-wide level (p = 2.7 × 10−8). Furthermore, the minor allele of rs7910977 associated significantly (p = 0.0046) with reduced LOAD risk (OR = 0.81 with a 95% CI of 0.70-0.94), as expected biologically from its association with elevated IDE expression. Conclusions: These results provide strong evidence that IDE is a late-onset Alzheimer disease (LOAD) gene with variants that modify risk of LOAD by influencing IDE expression. They also suggest that the use of expression levels as endophenotypes in genome-wide association studies may provide a powerful approach for the identification of disease susceptibility alleles. GLOSSARY AD = Alzheimer disease; CI = confidence interval; GWAS = genome-wide association study; LOAD = late-onset Alzheimer disease; mRNA = messenger RNA; OR = odds ratio; SNP = single nucleotide polymorphism. PMID:20142614

Sci-Thur AM: YIS – 03: Combining sagittally-reconstructed 3D and live-2D ultrasound for high-dose-rate prostate brachytherapy needle segmentation

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

Hrinivich, Thomas; Hoover, Douglas; Surry, Kathlee

Ultrasound-guided high-dose-rate prostate brachytherapy (HDR-BT) needle segmentation is performed clinically using live-2D sagittal images. Organ segmentation is then performed using axial images, introducing a source of geometric uncertainty. Sagittally-reconstructed 3D (SR3D) ultrasound enables both needle and organ segmentation, but suffers from shadow artifacts. We present a needle segmentation technique augmenting SR3D with live-2D sagittal images using mechanical probe tracking to mitigate image artifacts and compare it to the clinical standard. Seven prostate cancer patients underwent TRUS-guided HDR-BT during which the clinical and proposed segmentation techniques were completed in parallel using dual ultrasound video outputs. Calibrated needle end-length measurements were usedmore » to calculate insertion depth errors (IDEs), and the dosimetric impact of IDEs was evaluated by perturbing clinical treatment plan source positions. The proposed technique provided smaller IDEs than the clinical approach, with mean±SD of −0.3±2.2 mm and −0.5±3.7mm respectively. The proposed and clinical techniques resulted in 84% and 43% of needles with IDEs within ±3mm, and IDE ranges across all needles of [−7.7mm, 5.9mm] and [−9.3mm, 7.7mm] respectively. The proposed and clinical IDEs lead to mean±SD changes in the volume of the prostate receiving the prescription dose of −0.6±0.9% and −2.0±5.3% respectively. The proposed technique provides improved HDR-BT needle segmentation accuracy over the clinical technique leading to decreased dosimetric uncertainty by eliminating the axial-to-sagittal registration, and mitigates the effect of shadow artifacts by incorporating mechanically registered live-2D sagittal images.« less

Design architecture of double spiral interdigitated electrode with back gate electrode for biosensor application

NASA Astrophysics Data System (ADS)

Fathil, M. F. M.; Arshad, M. K. Md.; Hashim, U.; Ruslinda, A. R.; Gopinath, Subash C. B.; M. Nuzaihan M., N.; Ayub, R. M.; Adzhri, R.; Zaki, M.; Azman, A. H.

2016-07-01

This paper presents the preparation method of photolithography chrome mask design used in fabrication process of double spiral interdigitated electrode with back gate biasing based biosensor. By learning the fabrication process flow of the biosensor, the chrome masks are designed through drawing using the AutoCAD software. The overall width and length of the device is optimized at 7.0 mm and 10.0 mm, respectively. Fabrication processes of the biosensor required three chrome masks, which included back gate opening, spiral IDE formation, and passivation area formation. The complete chrome masks design will be sent for chrome mask fabrication and for future use in biosensor fabrication.

21 CFR 880.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2010 CFR

2010-04-01

...) The modified device operates using a different fundamental scientific technology than a legally...) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6) For...

21 CFR 878.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2010 CFR

2010-04-01

...) The modified device operates using a different fundamental scientific technology than a legally...) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6) For...

21 CFR 866.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Code of Federal Regulations, 2010 CFR

2010-04-01

...) The modified device operates using a different fundamental scientific technology than a legally...) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6) For...