Instrumentation Laboratory landed 510(k) clearance from the Food & Drug Administration for its HemosIL D-Dimer HS 500 assay, which the company says can effectively rule out the possibility of thrombosis in patients.
The Bedford, Mass.-based company also announced a deal with Health Canada to license the product north of the border; the assay has been available in Europe for about 10 months. Instrumentation Laboratory said the clearance from regulators marks the beginning of its commercialization of the assay in North America, with the help of its distribution partner Beckman Coulter Inc. (NYSE:BEC).
The assay is an immunoassay used to determine levels of D-Dimer in human blood, according to according to a press release.
D-Dimer is a small protein fragment found in blood after a clot is broken down. The company says the test can be used to rule out in less than five minutes venous thromboembolism in patients suspected of deep vein thrombosis and pulmonary embolism.