Instrumentation Laboratory Receives FDA Clearance to Expand the Intended Use of HemosIL(R) D-D...( -Now for Exclusion of ...)

-Now for Exclusion of Venous Thromboembolism-

LEXINGTON, Mass., Aug. 28 /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 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 tim
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