Instrumentation Laboratory (IL)
Instrumentation Laboratory Receives FDA Clearance to Expand the Intended Use of HemosIL(R) D-Dimer Assay
Published in Medical Letter on the CDC and FDA, September 14th, 2008
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...
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