BEDFORD, Mass., June 15 /PRNewswire/ -- Instrumentation Laboratory (IL) today announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its HemosIL Liquid Heparin assay. Previously, the Company received a license for the product from Health Canada, as well as a European CE IVD Mark. With this latest clearance in the US, the company can now initiate commercialization in North America and European countries. IL will coordinate commercialization of the product in North America, with their distribution partner, Beckman Coulter, Inc.
HemosIL Liquid Heparin is a liquid, ready-to-use, universal heparin assay for the quantitative determination of unfractionated heparin (UFH) and low-molecular weight heparin (LMWH) activity in human citrated plasma. Fully automated on IL Hemostasis Testing Systems, it is a one-stage chromogenic assay, with excellent correlation with traditional two-stage assays, providing greater simplicity and efficiency. This allows customers to move testing from the specialty lab to the routine lab, 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.”
Instrumentation Laboratory Receives 510(K) Clearance From FDA for HemosIL Liquid Heparin Assay
UFH and LMWH are widely used anticoagulants, administered for the prophylaxis and treatment of a number of cardiovascular disorders, including venous thromboembolism, unstable angina and acute myocardial infarction. They are also administered to patients who undergo orthopedic, cardiovascular and other surgeries. UFH and LMWH monitoring is critical in assessing and determining the appropriate anticoagulant activity in these patients. Due to the extensive number of such patients, the availability of a chromogenic anti-Xa assay, readily and always available is key in ensuring effective monitoring, 24 hours a day/7 day a week.
Instrumentation Laboratory (www.ilus.com), founded in 1959, is a worldwide developer, manufacturer and distributor of in vitro diagnostic instruments, related reagents and controls for use primarily in hospitals and independent clinical laboratories. The company’s product lines include critical care systems, hemostasis systems and information management systems. IL’s GEM® product offerings, part of the critical care line, include the GEM Premier(TM) 4000 analyzer with Intelligent Quality Management (iQM®), the new GEM Premier 3500 analyzer with iQM and the GEM PCL Plus, a portable coagulation analyzer. IL’s hemostasis portfolio includes the ACL TOP® Family of Hemostasis Testing Systems, fully automated, high-productivity analyzers, including the ACL TOP and the new ACL TOP 500 CTS. IL also offers the new ACL AcuStar Hemostasis Testing System, the ACL ELITE® and ELITE PRO, other hemostasis analyzers and the HemosIL® line of reagents. IL is based in Bedford, Massachusetts.
The Instrumentation Laboratory logo, GEM, iQM, HemosIL, ACL, ACL TOP, ACL ELITE, ACL AcuStar, Premier and GEM OPL are trademarks of Instrumentation Laboratory Company and/or one of its subsidiaries or parent companies, and may be registered in the United States Patent and Trademark Office and in other jurisdictions. All other product names, company names, marks, logos, and symbols are trademarks of their respective owners.
