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 Haemonetics.
FDA 510(k) Cleared System, Multipurpose For In Vitro Coagulation Studies Devices (Product Code JPA)
About Product Code JPA - Regulatory Context
510(k) Submission Activity
181 total 510(k) submissions under product code JPA since 1976, with 181 receiving FDA clearance (average review time: 118 days).
Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.
FDA Review Time
Recent submissions under JPA have taken an average of 70 days to reach a decision - down from 119 days historically, suggesting improved FDA processing for this classification.
JPA devices are reviewed by the Hematology panel. Browse all Hematology devices →