Instrumentation Laboratory (IL), a developer of in-vitro diagnostic instruments, has secured the US Food and Drug Administration (FDA) 510(k) clearance of its HemosIL HIT-Ab (PF4-H) assay to be used on ACL TOP Family Hemostasis Testing Systems.
HemosIL HIT-Ab is a fully automated, on-demand assay to be used for Heparin-Induced Thrombocytopenia (HIT) on a Hemostasis testing system.
The assay detects antibodies related to HIT.
The ready-to-use liquid immunoassay generates results in minutes on an on-demand basis round the clock, thereby enabling clinicians to arrive at timely and well-informed therapeutic decisions required during critical cases.
The ACL TOP family of testing systems are a hemostasis testing platform which are used for routine or specialty testing in mid to high-volume labs thereby resulting in efficient patient care.
IL worldwide hemostasis marketing director Remo Tazzi said: "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."
HIT is a commonly occurring side effect of the administration of heparin therapy which if untreated can cause stroke, pulmonary embolism and death.
The addressing of HIT requires terminating heparin therapy, and involving expensive alternative anticoagulants.
Delay in diagnosis due to prolonged tests can increase the bleeding risk in patient, as well as increase the associated cost for the treatment.
It is addressed by the availability of the on-demand HemosIL HIT-Ab which facilitates quick treatment decisions while reducing patient risk and cost.