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.”