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:9/12/2017)... , Sept. 12, 2017  ValGenesis Inc., ... Solutions (VLMS), is pleased to announce the appointment ... member of its Board of Directors and Chairman ... VLMS enables life science companies to manage their ... use of paper in this process. Furthermore, ValGenesis ...
(Date:9/7/2017)... 7, 2017  For nearly two decades, New Life Agency has been ... Insurance industry. Today, New Life Agency announces a powerful three-way partnership designed ... ... ... http://pharmacarecard.com/ (PRNewsfoto/PharmaCareCard) ...
(Date:9/6/2017)... SAN ANTONIO , Sept. 6, 2017  Robert ... as a Pinnacle Professional Member in recognition of his ... Dr. Szewc serves as a Nephrologist at the practice ... services, emergency medicine, kidney care and hypertension solutions. He ... over 20 years of career experience, as well as ...
Breaking Medicine Technology:
(Date:9/22/2017)... (PRWEB) , ... September 22, 2017 , ... ... operations and financial setbacks, a senior finds a new lease on life with ... helped thousands of people resolve their problem with unsecured debt. The senior is ...
(Date:9/22/2017)... ... September 22, 2017 , ... “Cursed with ... an obligatory tithe, and the freedom experienced when breaking free from this misconception. ... author, Lysa M. Harrison. , Published by Christian Faith Publishing, Lysa M. Harrison’s ...
(Date:9/22/2017)... ... ... “Fruit of the Spirit: “Love””: a delightful adventure of two friends who play ... Spirit: “Love”” is the creation of published author, Halimah Jones, who was born and ... an avid writer, her inspiration for “Fruit of the Spirit: “Love”” blossomed from her ...
(Date:9/21/2017)... ... September 21, 2017 , ... With ProSlideshow Portrait from Pixel Film Studios ... Users can select from up to two layers of subject matter along with fully ... all within Final Cut Pro X. , With ProSlideshow Portrait each user ...
(Date:9/21/2017)... (PRWEB) , ... September 21, 2017 , ... ... **An FDAnews Management Report**, http://www.fdanews.com/products/54818-promotional-communication      , In the competitive world of ... can get while staying in compliance with FDA rules. , The FDA has ...
Breaking Medicine News(10 mins):