Navigation Links
Instrumentation Laboratory Receives FDA Clearance to Expand the Intended Use for HemosIL(R) D-Dimer HS Assay
Date:10/9/2007

- Now for Exclusion of Venous Thromboembolism -

LEXINGTON, Mass., Oct. 9 /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 HemosIL D-Dimer HS to exclude venous thromboembolism (VTE) in outpatients suspected of deep vein thrombosis (DVT) and pulmonary embolism (PE), when used in conjunction with a clinical pretest probability assessment model. HemosIL D-Dimer HS was released in 2005 with claims for use as an aid in the diagnosis of VTE.

As part of the 510(k), IL submitted data from a multi-center clinical study conducted at four different hospitals using HemosIL D-Dimer HS on the ACL TOP(R) Hemostasis Testing System with 668 samples from patients admitted consecutively to the emergency department, suspected of having DVT or PE. HemosIL D-Dimer HS safely excluded DVT or PE with a negative predictive value of 100%.

HemosIL D-Dimer HS is the latest generation D-Dimer assay and features expanded working range, high analytical sensitivity, virtually no interference from rheumatoid factor and minimal optical interference from hemoglobin, lipemia and bilirubin. It is fully automated on the ACL TOP system with time to results in less than five minutes.

"This milestone exemplifies IL's focus on robust, reliable and easy-to-use assays with clear indications for use and proven clinical performance for disease-state-management," said Giovanni Russi, Director of Worldwide Marketing, Hemostasis Reagents at IL. "We hope that these new claims for D-Dimer HS will help physicians more accurately and efficiently diagnose patients suspected of VTE."

Instrumentation Laboratory (http://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 4000 analyzer with Intelligent Quality Management (iQM(R)), GEM Premier 3000 analyzer, GEM OPL(TM), a portable whole blood CO-Oximeter and the GEM PCL Plus, a portable Coagulation analyzer. IL's hemostasis portfolio includes the ACL TOP(R), a fully automated, high-productivity analyzer and the ACL ELITE(R), the latest addition to the ACL family. IL also offers the HemosIL(R) line of reagents. IL is based in Lexington, Massachusetts.


'/>"/>
SOURCE Instrumentation Laboratory
Copyright©2007 PR Newswire.
All rights reserved

Related biology technology :

1. The combination of monolithic columns and modern HPLC/MS/MS instrumentation for high chromatographic throughput and sensitive detection of beta-agonists
2. Setting up the laboratory to avoid contamination
3. Improving the Efficiency of Common Filtration Tasks in your Laboratory
4. Practical Applications of HyperDSC in a Pharmaceutical Laboratory
5. E-business conference to give sneak peek into university RFID laboratory
6. Medical College receives $377K to study brain disease
7. Lucigen receives $750K grant to boost biofuel yields
8. Medical College receives $1.4M cancer grant
9. Wisconsin biotech firm receives $107K NIH grant
10. InvivoSciences receives NIH grant for heart technology
11. Medical College receives $11 million grant to study high blood pressure
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/16/2017)... (PRWEB) , ... August 16, 2017 , ... ... changing into a different cell type. Many treatments for specific cancers, such as ... example of targeted treatment is androgen deprivation therapy for advanced prostate cancer. ...
(Date:8/16/2017)... ... August 16, 2017 , ... Today, 3Bar Biologics ... secured $2M in funding from an impressive group of investors, including Rev1 Ventures, ... Fund. With this investment, 3Bar is broadening availability of its groundbreaking offering that ...
(Date:8/16/2017)... 16, 2017  This year,s edition of the Inc. 5000 features a ... workforce solutions, has made the list for the third year in a ... fastest-growing private companies based on a set of quantitative metrics. In addition, ... fastest-growing companies in the Bay State . ... Inc. 5000 ...
(Date:8/15/2017)... , Aug. 15, 2017 After spending the past two ... with crowdsourced data collection, GeneFo now offers this platform to healthcare ... and amplifying support, adherence, and data collection vis a vis their ... mark the successful launch of this offer. ... GeneFo ...
Breaking Biology Technology:
(Date:4/3/2017)...  Data captured by IsoCode, IsoPlexis Corporation,s ... statistically significant association between the potency of ... objective response of cancer patients post-treatment. The ... cancer patients will respond to CAR-T cell ... to improve both pre-infusion potency testing and cell ...
(Date:3/30/2017)... March 30, 2017 The research team of ... three-dimensional (3D) fingerprint identification by adopting ground breaking 3D fingerprint minutiae ... realm of speed and accuracy for use in identification, crime investigation, ... cost. ... A research ...
(Date:3/29/2017)... 2017  higi, the health IT company that operates ... America , today announced a Series B investment ... EveryMove. The new investment and acquisition accelerates higi,s strategy ... transform population health activities through the collection and workflow ... higi collects and secures data today on behalf of ...
Breaking Biology News(10 mins):