Navigation Links
Instrumentation Laboratory Receives FDA Clearance to Expand the Intended Use of HemosIL(R) D-Dimer Assay
Date:8/28/2008

-Now for Exclusion of Venous Thromboembolism-

LEXINGTON, Mass., Aug. 28 /PRNewswire/ -- Instrumentation Laboratory (IL) today announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance to expand the intended use for the HemosIL D-Dimer assay to exclude venous thromboembolism (VTE) in outpatients suspected of deep venous thrombosis (DVT) and pulmonary embolism (PE), when used in conjunction with a clinical pretest probability (PTP) assessment model. HemosIL D-Dimer was originally released in 1998, for the quantitative determination of D-Dimer in human citrated plasma and in 2005 was FDA cleared for use as an aid in the diagnosis of VTE.

As a part of the 510(k), IL performed a multi-center clinical study involving more than six-hundred patients in four different hospitals, according to a strict protocol reviewed through the FDA. Using a cut-off value of 230 ng/mL, the Negative Predicative Value was 100% for DVT and PE on the ACL TOP(R) Hemostasis Testing System and 100% for DVT and 99.1% for PE on the ACL ELITE(R) system.

In 2007, the FDA granted clearance for the same VTE exclusionary claims with IL's second-generation HemosIL D-Dimer HS assay. Both assays now have proven clinical performance for the exclusion of DVT and PE when used with a PTP assessment model and share the same cut-off value.

"This expanded intended use for our D-Dimer assay allows IL to provide the tools healthcare professionals need to more accurately and efficiently rule-out patients suspected of DVT and PE, regardless of the size of their institution or the throughput of their analyzers," said Giovanni Russi, Director of Worldwide Marketing, Hemostasis Reagents at IL. "We are passionate about developing innovative products and offering all of our customers a full range of solutions through our comprehensive portfolio of hemostasis reagents and instruments."

HemosIL D-Dimer is fully automated on ACL systems, with tim
'/>"/>

SOURCE Instrumentation Laboratory (IL)
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2

Related biology technology :

1. Alliance for Medical Devices, Instrumentation and Diagnostics formed between Fraunhofer Center for Manufacturing Innovation and Boston University
2. Instrumentation Laboratory Receives FDA Clearance to Expand the Intended Use for HemosIL(R) D-Dimer HS Assay
3. Thermo Fisher Scientific Selected by China Doping Control Center to Supply Testing Instrumentation for the 2008 Olympic Games in Beijing
4. HealthTrust Expands Contract With Instrumentation Laboratory for Critical Care Portfolio to Include Consorta
5. Cepheid and Instrumentation Laboratory Introduce Xpert(TM) HemosIL(R) FII & FV Assay to European Clinical Testing Market
6. Instrumentation Laboratory Ships 1000th GEM Premier 4000 Analyzer to Scripps Health
7. Instrumentation Laboratory to Celebrate 50th Anniversary With 50 and Forward Program
8. Instrumentation Laboratory Announces Contract for Multi-Parameter Testing Products with Broadlane
9. PerkinElmer Expertise and Solutions Integral to Food Safety Monitoring for the Beijing Games : Methods, Applications Expertise and Instrumentation Deployed in Mobile Laboratory
10. Pharmatek Adds Cytotoxic and High-Potent Drug Development Capabilities to San Diego Laboratory
11. BioMarin Licenses Technology From Leading Cystic Fibrosis Research Laboratory at the University of California, San Francisco
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/3/2015)... Michigan (PRWEB) , ... September 03, 2015 , ... ... to release its non-invasive hydration monitoring wearable early 2016. , The device, ... level using proprietary optical and electrical sensing technology. These sensors track trending ...
(Date:9/2/2015)... 2015 Research and Markets ( ... Jain PharmaBiotech,s new report "Nanobiotechnology Applications, ... An increasing use of ... is anticipated. Nanotechnology will be applied at ... formulations for optimal delivery to diagnostic applications ...
(Date:9/2/2015)... , Sep. 02, 2015 ... announced the addition of Jain PharmaBiotech,s new report ... Companies" to their offering. This ... on technologies and applications. The report starts with ... estimation of markets. Technologies include array comparative genomic ...
(Date:9/2/2015)... DUBLIN , Sep. 02, 2015 ... announced the addition of Jain PharmaBiotech,s new report ... their offering. The markets for gene therapy ... approved gene therapy product and it is marketed in ... markets are estimated for the years 2014-2024. The estimates ...
Breaking Biology Technology:Technology Startup Halo Wearables to Unveil Non-Invasive Hydration Monitoring Device Early 2016 2Global Nanobiotechnology Applications, Markets and Companies Report 2015-2024 2Global Nanobiotechnology Applications, Markets and Companies Report 2015-2024 3Global Biochips and Microarrays Technologies, Markets and Companies Report 2015 with Market Size in 2014 and Projected Value for the Years 2019 and 2024 2Global Gene Therapy Market Study 2015-2024 - Technologies, Markets and Companies Analysis 2
... access is easily available. Many businesses offer Internet access ... However, recent news reports and editorials might lead you ... municipalities in terms of wireless access. Some suggest the ... , ,Mayor Dave Cieslewicz's plan to expand wireless ...
... of technologies -- one virtual, one corporeal -- were on ... Corp. presented its latest business awards. , ,The ... given awards or special recognitions to 60 businesses. Winners receive ... EDC has awarded $106,000 in cash awards and $246,000 in ...
... of Appeals for the Federal Circuit (CAFC) issued a patent-law ... patent applications worthless, and that will raise the bar for ... issue was whether certain gene fragment sequences were useful. Most ... use, as required by U.S. patent law. , ,The CAFC ...
Cached Biology Technology:Madison - Wired and unplugged 2Madison - Wired and unplugged 3StrandVision, Arctic Cool win Eau Claire business contest awards 2Court bars patent protection for certain gene fragments 2Court bars patent protection for certain gene fragments 3Court bars patent protection for certain gene fragments 4
(Date:8/12/2015)... Minn. , Aug. 12, 2015   MedNet ... supports the entire spectrum of clinical research, is proud ... , the company,s comprehensive SaaS-based eClinical technology platform, has ... during the first two quarters of 2015.   Q2 ... second largest quarters measured by contract value sold in ...
(Date:8/10/2015)... BOSTON and TELTOW, Germany ... SensoMotoric Instruments (SMI), a world leader in Eye ... the completion of its OEM Eye Tracking Platform for ... Eye Tracking Platform contains reference designs for seamless integration ... kiosk systems, virtual reality HMDs and augmented reality smart ...
(Date:8/5/2015)... CHICAGO , August 5, 2015 ... Identity & Access Management Market by Software, Services, Vertical (BFSI, ... Chemical/Pharma), & Geography - Global Forecast to 2020", published ... Access Management Market globally into various segments. The global ... in 2014 to $546.2 Million by 2019, at a ...
Breaking Biology News(10 mins):MedNet Solutions Experiences Explosive Corporate Growth 2SMI Completes OEM Eye Tracking Platform to Cover All Consumer Displays 2SMI Completes OEM Eye Tracking Platform to Cover All Consumer Displays 3Physical Identity and Access Management Market Worth $546.2 Million by 2019 2Physical Identity and Access Management Market Worth $546.2 Million by 2019 3Physical Identity and Access Management Market Worth $546.2 Million by 2019 4
... chief executive officer of DuPont, and Abby Joseph Cohen, ... & Co., will be featured speakers at a University ... to be held Friday, Nov. 2, in Clayton Hall, ... conference is the first in a new series of ...
... of marine microbes have been discovered at two deep-sea ... the MBL (Marine Biological Laboratory) and University of Washingtons ... Their findings, published in the October 5 issue of ... comprehensive, comparative study to date of deep-sea microbial communities ...
... (ESA) is proud to announce its selection of ... as an ESA Fellow acknowledges outstanding contributions in research, ... have have participated actively in ESA affairs and served ... be recognized during the ESA Annual Meeting, which will ...
Cached Biology News:UD hosts conference on knowledge-based partnerships Nov. 2 2Hydrothermal vents: Hot spots of microbial diversity 2Entomological Society of America recognizes 2007 fellows and honorary members 2Entomological Society of America recognizes 2007 fellows and honorary members 3
... the efficient enrichment of functional endoplasmic ... cell culture. The isolated ER are ... metabolic pathway analysis. Metabolic abnornalities of ... children, cystic fibrosis and many more ...
Plasmid expressing the LacZ reporter gene....
... culture flasks have triple baffles located at ... achieve maximal oxygen transfer to culture medium. ... A wide range of optional caps are ... colored caps for ease of sorting and ...
...
Biology Products: