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Instrumentation Laboratory Receives 510(K) Clearance From FDA and Canadian License for HemosIL(R) D-Dimer HS 500 Assay
Date:2/23/2010

e 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.

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