Healthcare Industry News:  intended use 

Diagnostics FDA

 News Release - October 9, 2007

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 (HSMN NewsFeed) -- 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® 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 (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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