FDA Product Code JPA: System, Multipurpose For In Vitro Coagulation Studies

Under FDA product code JPA, multipurpose in vitro coagulation study systems are cleared for comprehensive coagulation testing in clinical laboratories.

These analyzer platforms perform multiple coagulation assays — including PT, aPTT, fibrinogen, and specialized factor assays — on a single instrument, providing a complete coagulation profile for the diagnosis and monitoring of bleeding and thrombotic disorders.

JPA devices are Class II medical devices, regulated under 21 CFR 864.5425 and reviewed by the FDA Hematology panel.

Leading manufacturers include Instrumentation Laboratory CO, Haemonetics Corporation and Sysmex America, Inc..