Navigation Links
Instrumentation Laboratory Receives 510(K) Clearance From FDA and Canadian License for HemosIL(R) D-Dimer HS 500 Assay
Date:2/23/2010

BEDFORD, Mass., Feb. 23 /PRNewswire/ -- Instrumentation Laboratory (IL) today announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its HemosIL D-Dimer HS 500 assay.  Additionally, the Company received a license from Health Canada for the product.  The Company will now initiate commercialization of HemosIL D-Dimer HS 500 in North America, with their distribution partner, Beckman Coulter, Inc.  In April 2009, the assay was previously released in Europe, after receiving the European CE IVD Mark.  

HemosIL D-Dimer HS 500 is a liquid, ready-to-use, automated latex-enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on the ACL TOP® Family of Hemostasis Testing Systems for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude venous thromboembolism (VTE) in outpatients suspected of deep venous thrombosis (DVT) and pulmonary embolism (PE).  The assay's liquid, ready-to-use format, with time to results in less than five minutes, provides customers with superior ease of use and efficiency versus traditional methods.  

"HemosIL D-Dimer HS 500 is the latest generation assay to join our robust D-Dimer assay family, including HemosIL  D-Dimer and D-Dimer HS assays, which are among a select few cleared by the FDA for the exclusion of VTE," said Giovanni Russi, Director of Worldwide Marketing, Hemostasis Reagents at IL.  "This new assay offers even greater ease of use and enhanced clinical performance, and is another example of IL's commitment to innovation in Hemostasis diagnostics."  

As part of the 510(k) filing, IL submitted data from single and multi-center management studies.  The studies demonstrated that HemosIL D-Dimer HS 500 is highly accurate with 100% Negative Predictive Value for VTE on the ACL TOP and can thus be an invaluable patient management tool.  It has a cut-off for the exclusion of DVT and PE of 500 ng/mL FEU.

About VTE

DVT occurs when a blood clot forms in a large vein, usually in a leg.  A potentially fatal PE happens if the blood clot breaks loose, migrates to the lungs and blocks a pulmonary artery or one of its branches.  These conditions can occur after any surgery, as well as in patients with spinal fractures and spinal-cord injury, though it is most commonly seen in patients who have recently undergone orthopedic surgery. Two hundred thousand new cases of DVT and PE occur in the US annually and 20% suffer sudden death as a result of PE.  Learn more by visiting www.preventdvt.org

Instrumentation Laboratory (www.ilus.com), founded in 1959, is a worldwide developer, manufacturer and distributor of in vitro diagnostic instruments, related reagents and controls for use primarily in hospitals and independent clinical laboratories.  The company's product lines include critical care systems, hemostasis systems and information management systems.  IL's GEM® product offerings, part of the critical care line, include the new GEM Premier 3500 with Intelligent Quality Management (iQM®), GEM Premier™ 4000 analyzer, GEMweb Plus Custom Connectivity, and the GEM PCL Plus, a portable coagulation analyzer.  IL's hemostasis portfolio includes the ACL TOP® Family of Hemostasis Testing Systems, fully automated, high-productivity analyzers, including the ACL TOP, the new ACL TOP LAS and the ACL TOP 500 CTS.  IL also offers the new ACL AcuStar™, ACL ELITE® and ELITE PRO, other hemostasis analyzers and the HemosIL® line of reagents.  IL is based in Bedford, Massachusetts.

The Instrumentation Laboratory logo, GEM, iQM, HemosIL, ACL TOP, ACL ELITE, ACL AcuStar and Premier are trademarks of Instrumentation Laboratory Company and/or one of its subsidiaries or parent companies, and may be registered in the United States Patent and Trademark Office and in other jurisdictions.  All other product names, company names, marks, logos, and symbols are trademarks of their respective owners.

SOURCE Instrumentation Laboratory

Back to top

RELATED LINKS
www.ilus.com

'/>"/>

SOURCE Instrumentation Laboratory
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Instrumentation Laboratory Receives FDA Clearance for HemosIL RecombiPlasTin 2G Assay
2. Instrumentation Laboratory Installs 2000th ACL TOP(R) System
3. Amerinet Awards Contract to Instrumentation Laboratory for Critical Care Portfolio
4. BD and PEPFAR Collaborate to Strengthen Laboratory Systems in Fight Against HIV/AIDS and TB
5. Focus Diagnostics Launches Laboratory Test for Chikungunya Virus
6. Eating Walnuts Slows Cancer Growth, Laboratory Study Finds
7. J. Craig Venter, Ph.D. Receives Double Helix Medal from Cold Spring Harbor Laboratory
8. Gene Therapy Corrects Sickle Cell Disease in Laboratory Study
9. deCODE Receives California Clinical Laboratory License
10. Quest Diagnostics ClariSure(TM) Postnatal Molecular Test Receives Clinical Laboratory Approval from New York State
11. BARC Central Laboratory Joins Alzheimers Association Research Roundtable
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/23/2017)... -- Transportation Insight, a multi-modal lead logistics solutions provider receives ... with expertise serving clients in the food industry. Vice ... was named a 2017 Food Logistics Champion: ... publication exclusively dedicated to covering the movement of product ... has brought to Transportation Insight a wealth of knowledge ...
(Date:3/23/2017)... As a result of diagnostic technology ... of allergic diseases, cutting edge developments in targeted ... ways in which pharmaceutical and biotech companies are ... be both a high quality meeting and a ... immunologists, research scholars and doctors. The event will ...
(Date:3/23/2017)... , March 23, 2017   BioSpace , the ... has partnered with Indiana Biosciences Research Institute ... organizations and educational institutions to bring the state,s life ... BioIndiana Hotbed map, an artistic representation of the region,s ... presented to Vice President Mike Pence , a ...
Breaking Medicine Technology:
(Date:3/23/2017)... ... 2017 , ... PAINWeekEnd (PWE) Oklahoma City, on April 22 ... be an educational and exciting program providing busy clinicians and allied healthcare practitioners ... , Oklahoma is in a healthcare crisis. The state ranks 46th in America ...
(Date:3/23/2017)... ... 2017 , ... March is National Kidney Month – the perfect time to ... maintaining good health. Every day, two kidneys filter about 120 to 150 quarts of ... blood, eliminating waste, regulating fluid levels and blood pressure, supporting bone health and promoting ...
(Date:3/23/2017)... Scottsdale, AZ (PRWEB) , ... March 23, 2017 , ... ... helping people around the world to manage stress and anxiety. , “Buzzies change ... Serin, neuropsychologist, inventor and co-founder of Buzzies. , Since its launch date in December ...
(Date:3/23/2017)... ... 2017 , ... ?This conference will prominently feature 150+ Hospital and Health System Executive Speakers including: ... Salka , 43rd President of the United States of America: George W. Bush ... and Out of the Ring: Sugar Ray Leonard , JD, Chairperson, McGuireWoods LLP: ...
(Date:3/23/2017)... ... March 23, 2017 , ... It’s that time of year ... are thinking about summer internships , which can be frustrating when they don’t ... at Garden Media Group, a boutique public relations firm outside of Philadelphia, have offered ...
Breaking Medicine News(10 mins):