Angiology
Instrumentation Laboratory Receives FDA Clearance to Expand the Intended Use for HemosIL(R) D-Dimer HS Assay
Published in Medical Letter on the CDC and FDA, October 28th, 2007
Instrumentation Laboratory (IL) 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(R) Hemostasis Testing System with 668 samples from...
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