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, Iline Microsystems, S.L. and Siemens Healthcare Diagnostics.
FDA 510(k) Cleared Test, Time, Prothrombin Devices (Product Code GJS)
About Product Code GJS - Regulatory Context
510(k) Submission Activity
127 total 510(k) submissions under product code GJS since 1978, with 127 receiving FDA clearance (average review time: 137 days).
Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 6 in the prior period.
FDA Review Time
Recent submissions under GJS have taken an average of 64 days to reach a decision - down from 138 days historically, suggesting improved FDA processing for this classification.
GJS devices are reviewed by the Hematology panel. Browse all Hematology devices →