NEW YORK (360Dx) – Instrumentation Laboratory announced today that its HemosIL AcuStar HIT-IgG(PF4-H) assay and controls have received 510(k) clearance from the US Food and Drug Administration.
The assay is a chemiluminescent reagent on a hemostasis testing system for the rapid qualitative detection of platelet factor 4-heparin complex IgG antibodies associated with heparin-induced thrombocytopenia — an immunologic adverse reaction to heparin that causes blood clot formation. It runs on the fully automated ACL AcuStar Hemostasis testing system.
Previously, the HemosIL HIT-Ab(PF4-H) assay received 510(k) clearance in July 2016.
"The HemosIL AcuStar HIT-IgG(PF4-H) assay is an important complement to our latex-based HemosIL HIT-Ab(PF4-H) assay, expanding the IL portfolio for this critically important test," Giovanni Russi, vice president of worldwide marketing and service at Instrumental Laboratory, said in a statement. "These assays enable faster and more effective patient management, reducing expensive and unnecessary therapeutic changes."