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news.Instrumentation Laboratory, a developer of in vitro diagnostic instruments, has announced that the FDA has granted 510(k) clearance to expand the intended use for the HemosIL D-dimer assay to exclude venous thromboembolism in outpatients suspected of deep venous thrombosis and pulmonary embolism, when used in conjunction with a clinical pretest probability assessment model.
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As a part of the 510(k), Instrumentation Laboratory (IL) performed a multi-center clinical study involving more than 600 patients in four different hospitals, according to a strict protocol reviewed through the FDA.
Using a cut-off value of 230ng/ml, the negative predicative value was 100% for deep venous thrombosis (DVT) and pulmonary embolism (PE) on the ACL Top hemostasis testing system and 100% for DVT and 99.1% for PE on the ACL Elite system.
Giovanni Russi, director of worldwide marketing for hemostasis reagents at IL, said: “This expanded intended use for our D-Dimer assay allows IL to provide the tools healthcare professionals need to more accurately and efficiently rule-out patients suspected of DVT and PE, regardless of the size of their institution or the throughput of their analyzers.”