Instrumentation Laboratory Receives FDA Clearance for HemosIL Assay

Instrumentation Laboratory received 510(k) clearance for its HemosIL AcuStar assay for detection of antibodies associated with heparin-induced thrombocytopenia (HIT) and HemosIL AcuStar HIT Controls.

The assay is a fully automated, chemiluminescent reagent on a hemostasis testing system for the qualitative detection of platelet factor 4 (PF4)-heparin complex IgG antibodies associated with HIT. The chemiluminescent technology enables high analytical sensitivity and precision.

The device provides enhanced detection of HIT antibodies on ACL AcuStar hemostasis testing systems.