Navigation Links
Instrumentation Laboratory Receives FDA Clearance to Expand the Intended Use for HemosIL(R) D-Dimer HS Assay

- 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 (, 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:
(Date:6/23/2016)... 2016   Boston Biomedical , an industry ... to target cancer stemness pathways, announced that its ... Drug Designation from the U.S. Food and Drug ... including gastroesophageal junction (GEJ) cancer. Napabucasin is an ... cancer stemness pathways by targeting STAT3, and is ...
(Date:6/23/2016)... , June 23, 2016  The Prostate Cancer Foundation (PCF) ... precise treatments and faster cures for prostate cancer. Members of the Class of ... 15 countries. Read More About the Class of 2016 ... ... ...
(Date:6/23/2016)... ... June 23, 2016 , ... In a new case report published today in ... patient who developed lymphedema after being treated for breast cancer benefitted from an injection ... for dealing with this debilitating, frequent side effect of cancer treatment. , ...
(Date:6/23/2016)... Francisco, CA (PRWEB) , ... June 23, 2016 ... ... (EDC) software, is exhibiting at the Pennsylvania Convention Center and will showcase its ... Annual conference. ClinCapture will also be presenting a scientific poster on Disrupting Clinical ...
Breaking Biology Technology:
(Date:6/22/2016)... 2016 On Monday, the Department of Homeland ... share solutions for the Biometric Exit Program. The Request ... Protection (CBP), explains that CBP intends to add biometrics ... the United States , in order to deter ... Logo - ...
(Date:6/15/2016)... New York , June 15, 2016 /PRNewswire/ ... a new market report titled "Gesture Recognition Market by ... and Forecast, 2016 - 2024". According to the report, ... USD 11.60 billion in 2015 and is estimated ... reach USD 48.56 billion by 2024.  ...
(Date:6/3/2016)... LONDON , June 3, 2016 /PRNewswire/ ... Transport Management) von Nepal ... ,Angebot und Lieferung hochsicherer geprägter Kennzeichen, einschließlich ... weltweit führend in der Produktion und Implementierung ... an der Ausschreibung im Januar teilgenommen, aber ...
Breaking Biology News(10 mins):