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 and Sysmex America, Inc..
List of System, Multipurpose For In Vitro Coagulation Studies devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for System, Multipurpose For In Vitro Coagulation Studies devices (product code JPA). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Hematology FDA review panel. Browse all Hematology devices →