Healthcare Industry News:  thrombin 

Diagnostics FDA

 News Release - September 25, 2007

Instrumentation Laboratory Receives FDA Clearance for HemosIL RecombiPlasTin 2G Assay

Second Generation Reagent for Blood Coagulation Testing

LEXINGTON, Mass., Sept. 25 (HSMN NewsFeed) -- Instrumentation Laboratory (IL) today announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for HemosIL® RecombiPlasTin 2G. This new product is the second generation of HemosIL RecombiPlasTin, one of the most widely used Prothrombin Time (PT) reagents in the world.

HemosIL RecombiPlasTin 2G is performed for pre-surgical screening to evaluate the extrinsic coagulation pathway and to monitor oral anticoagulant therapy. It is based on recombinant tissue factor and a blend of synthetic phospholipids, which allow high sensitivity and lot-to-lot consistency. Additionally, the reagent is insensitive to the new antibiotic Cubicin (daptomycin for injection) and has an ISI value of approximately 1.0 on IL's ACL analyzers, traceable to WHO standards.

"RecombiPlasTin 2G is another example of IL's commitment to continuous product improvement and innovation," said Giovanni Russi, Director of Worldwide Marketing, Hemostasis Reagents at IL. "We are dedicated to delivering the best hemostasis and critical care diagnostics to healthcare providers and ultimately, contributing to the betterment of patient care."

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 4000 analyzer with Intelligent Quality Management (iQM®), 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®, a fully automated, high-productivity analyzer and the ACL ELITE, the latest addition to the ACL family. IL also offers the HemosIL® line of reagents. IL is based in Lexington, Massachusetts.


Source: Instrumentation Laboratory

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