IL Receives 510(k) for HemosIL D-Dimer Assay

The FDA has given 510(k) clearance for Instrumentation Laboratory's (IL) HemosIL D-Dimer assay, clarifying the product's intended use and introducing new data from a management study in the product insert.

The clarified claim allows hospitals and commercial reference laboratories to use the test as an aid in the diagnosis of deep vein thrombosis (DVT) and pulmonary embolism (PE). In addition, a negative predictive value of 100 percent was obtained with HemosIL D-Dimer in a study performed on 300 frozen samples from patients admitted consecutively to an emergency unit with suspected DVT or PE.

The intended use statement in the labeling will read: HemosIL D-Dimer is an automated latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on IL Coagulation Systems as an aid in the diagnosis of venous thromboembolism [deep venous thrombosis (DVT) and pulmonary embolism (PE)].