Instrumentation Laboratory (IL) announced that it has received US FDA 510(k) clearance for its HemosIL Liquid Heparin assay. The product also received Health Canada and European CE IVD mark approval earlier. The company initiates commercialization in North America and European countries with this latest clearance in the US. In North America IL will commercialize the product with their distribution partner, Beckman Coulter, Inc.
HemosIL Liquid Heparin assay is used for the quantitative determination of unfractionated heparin (UFH) and low-molecular weight heparin (LMWH) activity in human citrated plasma. It is fully automated one-stage chromogenic assay of IL Hemostasis Testing Systems. It provides excellent correlation with traditional two-stage assays, providing greater simplicity and efficiency. This allows testing in routine labs ensuring availability 24 hours/day, 7 days/week.
We are very pleased with the rapid clearance of HemosIL Liquid Heparin by the FDA. This speaks to its significance to the medical community, said Giovanni Russi, Director of Marketing, Hemostasis Reagents at Instrumentation Laboratory. It is an exciting breakthrough for healthcare providers who treat the thousands of patients around the world using UFH and LMWH. This will enable more rapid and accurate monitoring of prophylaxis and treatment.
UFH and LMWH anticoagulants are administered for the treatment of number of cardiovascular disorders and prophylaxis. The cardiovascular disorders treated include venous thromboembolism, unstable angina and acute myocardial infarction. UFH and LMWH anticoagulants are also administered for patients who undergo orthopedic and other surgeries. The monitoring of UFH and LMWH is critical in assessing and determining the appropriate anticoagulant activity in these patients.