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:8/28/2014)... Ca. (PRWEB) August 28, 2014 Best ... rating for an alcohol-based hand sanitizer, asks food processors ... by comparing the hand sanitizer they’re currently using to ... . Hand hygiene is critical to fighting cross-contamination and ... Best Sanitizers believes there are key criteria that ...
(Date:8/28/2014)... 28, 2014 The ability for organizations ... that will allow individuals to perform at the highest ... for employers looking to compete in this post–recession era. ... this trend, as the sector increasingly focuses on the ... which will have real results on the organization's development ...
(Date:8/28/2014)... TALLAHASSEE, Fla. Exciting new work by a Florida ... molecular system that can take your temperature, emit white ... , And, the molecule looks like a butterfly. , ... and Biomedical Engineering in the FAMU-FSU College of Engineering, ... ago, but has continued to discover that his creation ...
(Date:8/28/2014)... San Diego, CA (PRWEB) August 28, 2014 ... products, Pipette.com is offering a promotion for ... enables Pipette.com customers to purchase the highest quality ... Centrifuge Tubes are ideal for customers doing chemical, ... benefit lab technicians who are not regularly able ...
Breaking Biology Technology:Food Processors and Food Handlers are Encouraged to Prepare for Fall Harvest by Evaluating Their Current Hand Sanitizer Using Nine Key Criteria 2Food Processors and Food Handlers are Encouraged to Prepare for Fall Harvest by Evaluating Their Current Hand Sanitizer Using Nine Key Criteria 3Klein Hersh International Leads Philadelphia Area Life Science Industry in Company Culture 2Klein Hersh International Leads Philadelphia Area Life Science Industry in Company Culture 3Novel 'butterfly' molecule could build new sensors, photoenergy conversion devices 2Eppendorf Safe Lock Centrifuge Tube Promotion Now Available at Major Pipette Distributor Pipette.com 2Eppendorf Safe Lock Centrifuge Tube Promotion Now Available at Major Pipette Distributor Pipette.com 3
... Veteran healthcare executive brings solid experience with international ... healthcare and technology companies, ... management tools, announced the appointment of,Guillermo Moreno as its vice ... for developing and implementing strategic,initiatives to grow the company,s business ...
... Corporation,(Nasdaq: SIAL ) will be presenting at the ... at 8:30 AM ET at the Grand Hyatt in,New ... broadcast over the,Internet available at http://ir.sigmaaldrich.com . Users ... the webcast on, http://ir.sigmaaldrich.com users will need to ...
... FREMONT, Calif., Sept. 17 Quark ... and developing novel,RNA interference (RNAi)-based therapeutics, ... the 5th Annual RNAi Europe, taking ... Three of Quark,s scientists,Igor Mett, Hagar ...
Cached Biology Technology:Guillermo Moreno Named Aurillion's Vice President of Sales and Marketing 2Quark Pharmaceuticals Announces Poster Presentations at RNAi Europe 2008 2Quark Pharmaceuticals Announces Poster Presentations at RNAi Europe 2008 3
(Date:8/28/2014)... Clinic researcher and his collaborators have developed an online ... process of re-engineering cells for biomedical investigation. CellNet is ... to aid stem cell engineering. Details of CellNet and ... two back-to-back papers in the journal Cell . ... uses for all types of cell-based investigations and can ...
(Date:8/28/2014)... MD FASEB MARC (Maximizing Access to Research ... for the Genetics Society of America,s 27th Annual ... October 3, 2014 in Pacific Grove, California. ... of students, post doctorates and scientists from underrepresented ... community and to encourage the participation of young ...
(Date:8/28/2014)... -- Scientists have identified the developmental on-off switch for ... produce more than two-thirds of the world,s naturally derived ... to see whether it is possible to manipulate this ... , The study, appearing August 28 in Cell ... molecule called cyclic-di-GMP and a larger protein called BldD ...
Breaking Biology News(10 mins):New tool aids stem cell engineering for medical research 2Small molecule acts as on-off switch for nature's antibiotic factory 2Small molecule acts as on-off switch for nature's antibiotic factory 3
... The World Science Festival launches its first full day with ... will feature a keynote address by Harold Varmus, co-chair of ... well as a live simulcast of the announcement of the ... Oslo, Norway. A panel discussion follows, moderated by Elizabeth ...
... (May 14, 2010)--The New York Stem Cell Foundation (NYSCF) ... Robertson Foundation, established by Julian and Josie Robertson. ... will provide funding for NYSCF-Robertson Investigators in NYSCF,s new ... the NYSCF-Robertson Stem Cell Prize. This award ...
... 2010 The same digital technology that enables young people ... immerse them in a simulated coral reef environment where they ... project led by Field Museum scientists will link students from ... reef environments in the Pacific Ocean, engage in the scientific ...
Cached Biology News:Field Museum technology project wins prestigious award 2
... Isothermal Block is an anodized aluminum, solvent-resistant ... and to provide efficient thermal transfer to ... design of the HT96 Isothermal Block replaces ... product design allowing for compatibility with robotic ...
Human monocyte-derived dendritic cells, For immunohistochemistry (IHC) Cell Chip with Human Peripheral Blood Dendritic Cells and EPCs...
...
...
Biology Products: