FDA Product Code GJS: Test, Time, Prothrombin
Monitoring the coagulation cascade is critical in patients on anticoagulant therapy. FDA product code GJS covers prothrombin time tests.
The PT test measures the time it takes for plasma to clot via the extrinsic coagulation pathway, reflecting the activity of factors I, II, V, VII, and X. It is expressed as INR for warfarin monitoring and is used in the assessment of liver function and coagulopathies.
GJS devices are Class II medical devices, regulated under 21 CFR 864.7750 and reviewed by the FDA Hematology panel.
Leading manufacturers include Roche Diagnostics, Siemens Healthcare Diagnostics and Instrumentation Laboratory CO.
List of Test, Time, Prothrombin devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Test, Time, Prothrombin devices (product code GJS). 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 →