Instrumentation Laboratory (IL) has received 510(k) clearance from the US FDA for its HemosIL D-Dimer HS 500 assay. Additionally, the company has also received a license from Health Canada for the product.
Instrumentation Laboratory said that 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.
As part of the 510(k) filing, IL has 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.
IL will now initiate commercialization of HemosIL D-Dimer HS 500 in North America, with its distribution partner, Beckman Coulter. 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 TOP 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).
Giovanni Russi, director of worldwide marketing of Hemostasis Reagents at IL, said: “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. 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.”