Instrumentation Laboratory Receives 510(K) Clearance From FDA and Canadian License for HemosIL(R) D-Dimer HS 500 Assay
BEDFORD, Mass., Feb. 23 /PRNewswire/ — Instrumentation Laboratory (IL) today announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its HemosIL D-Dimer HS 500 assay. Additionally, the Company received a license from Health Canada for the product. The Company will now initiate commercialization of HemosIL D-Dimer HS 500 in North America, with their distribution partner, Beckman Coulter, Inc. In April 2009, the assay was previously released in Europe, after receiving the European CE IVD Mark.
HemosIL D-Dimer HS 500 is a liquid, ready-to-use, automated latex-enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on the ACL TOPÃ‚® Family of Hemostasis Testing Systems for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude venous thromboembolism (VTE) in outpatients suspected of deep venous thrombosis (DVT) and pulmonary embolism (PE). The assay’s liquid, ready-to-use format, with time to results in less than five minutes, provides customers with superior ease of use and efficiency versus traditional methods.
“HemosIL D-Dimer HS 500 is the latest generation assay to join our robust D-Dimer assay family, including HemosIL D-Dimer and D-Dimer HS assays, which are among a select few cleared by the FDA for the exclusion of VTE,” said Giovanni Russi, Director of Worldwide Marketing, Hemostasis Reagents at IL. “This new assay offers even greater ease of use and enhanced clinical performance, and is another example of IL’s commitment to innovation in Hemostasis diagnostics.”
As part of the 510(k) filing, IL submitted data from single and multi-center management studies. The studies demonstrated that HemosIL D-Dimer HS 500 is highly accurate with 100% Negative Predictive Value for VTE on the ACL TOP and can thus be an invaluable patient management tool. It has a cut-off for the exclusion of DVT and PE of 500 ng/mL FEU.
DVT occurs when a blood clot forms in a large vein, usually in a leg. A potentially fatal PE happens if the blood clot breaks loose, migrates to the lungs and blocks a pulmonary artery or one of its branches. These conditions can occur after any surgery, as well as in patients with spinal fractures and spinal-cord injury, though it is most commonly seen in patients who have recently undergone orthopedic surgery. Two hundred thousand new cases of DVT and PE occur in the US annually and 20% suffer sudden death as a result of PE. Learn more by visiting www.preventdvt.org
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 GEMÃ‚® product offerings, part of the critical care line, include the new GEM Premier 3500 with Intelligent Quality Management (iQMÃ‚®), GEM Premier(TM) 4000 analyzer, GEMweb Plus Custom Connectivity, and the GEM PCL Plus, a portable coagulation analyzer. IL’s hemostasis portfolio includes the ACL TOPÃ‚® Family of Hemostasis Testing Systems, fully automated, high-productivity analyzers, including the ACL TOP, the new ACL TOP LAS and the ACL TOP 500 CTS. IL also offers the new ACL AcuStar(TM), ACL ELITEÃ‚® and ELITE PRO, other hemostasis analyzers and the HemosILÃ‚® line of reagents. IL is based in Bedford, Massachusetts.
The Instrumentation Laboratory logo, GEM, iQM, HemosIL, ACL TOP, ACL ELITE, ACL AcuStar and Premier 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.
SOURCE Instrumentation Laboratory