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Instrumentation Laboratory gets FDA approval for HemosIL HIT-Ab(PF4-H) assay

MDBR Staff Writer Published 27 July 2016

In vitro diagnostic instruments producer Instrumentation Laboratory (IL) has received 510(k) clearance from the US Food and Drug Administration (FDA) for its new HemosIL HIT-Ab(PF4-H) assay.

The approval has been granted for the assay for use on ACL TOP family hemostasis testing systems.

The fully automated and on-demand assay for Heparin-Induced Thrombocytopenia (HIT) on a Hemostasis testing system will detect antibodies associated with HIT.   

HemosIL HIT-Ab(PF4-H) is a liquid and ready-to-use immunoassay that provides results in minutes, helping clinicians to take well-informed therapeutic decisions.

HIT is a severe immunologic adverse reaction to a Heparin complex, which leads to form blood clots that can result in venous or arterial thrombosis.

According to the company, management of HIT involves cessation of heparin therapy and initiation of expensive alternative anticoagulants.

Instrumentation Laboratory worldwide director Remo Tazzi said: "We are proud to remain at the forefront of Hemostasis testing solutions with this major milestone, marking the first FDA clearance of a fully automated HIT antibody assay that delivers results in minutes.

"Our mission is to develop products that enhance patient care while enabling greater efficiency in the laboratory.  The HemosIL HIT-Ab(PF4-H) assay is an exemplary achievement of this goal."

The firm develops and produces in vitro diagnostic instruments, related reagents and controls for use primarily in hospitals and independent clinical laboratories.

It produces products such as critical care systems, hemostasis systems and information management systems.