Instrumentation Laboratory Receives FDA Clearance To Expand The Intended Use Of HemosIL(R) D-Dimer Assay

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 30 Aug 2008 - 1:00 PDT

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Instrumentation Laboratory (IL) announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance to expand the intended use for the HemosIL D-Dimer assay to exclude venous thromboembolism (VTE) in outpatients suspected of deep venous thrombosis (DVT) and pulmonary embolism (PE), when used in conjunction with a clinical pretest probability (PTP) assessment model. HemosIL D-Dimer was originally released in 1998, for the quantitative determination of D-Dimer in human citrated plasma and in 2005 was FDA cleared for use as an aid in the diagnosis of VTE.

As a part of the 510(k), IL performed a multi-center clinical study involving more than six-hundred patients in four different hospitals, according to a strict protocol reviewed through the FDA. Using a cut-off value of 230 ng/mL, the Negative Predicative Value was 100% for DVT and PE on the ACL TOP(R) Hemostasis Testing System and 100% for DVT and 99.1% for PE on the ACL ELITE(R) system.

In 2007, the FDA granted clearance for the same VTE exclusionary claims with IL's second-generation HemosIL D-Dimer HS assay. Both assays now have proven clinical performance for the exclusion of DVT and PE when used with a PTP assessment model and share the same cut-off value.

"This expanded intended use for our D-Dimer assay allows IL to provide the tools healthcare professionals need to more accurately and efficiently rule-out patients suspected of DVT and PE, regardless of the size of their institution or the throughput of their analyzers," said Giovanni Russi, Director of Worldwide Marketing, Hemostasis Reagents at IL. "We are passionate about developing innovative products and offering all of our customers a full range of solutions through our comprehensive portfolio of hemostasis reagents and instruments."

HemosIL D-Dimer is fully automated on ACL systems, with time to results in less than seven minutes. It was the first D-Dimer test automated on IL's ACL systems and since its launch, much has been published about its excellent performance for the diagnosis of both DVT and PE.

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 http://www.preventdvt.org

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(R) product offerings, part of the critical care line, include the new GEM Premier 4000 analyzer with Intelligent Quality Management (iQM(R)), GEM Premier(TM) 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) Family of Hemostasis Testing Systems, fully automated, high-productivity analyzers, including the ACL TOP and the new ACL TOP 500 CTS. IL also offers the ACL ELITE(R) and ELITE PRO, other hemostasis analyzers and the HemosIL(R) line of reagents. IL is based in Lexington, Massachusetts.

Instrumentation Laboratory (IL)
http://www.ilus.com