FDA product code · Hematology · Class 2
GJS: Test, Time, Prothrombin
GJS is FDA's product code for "Test, Time, Prothrombin": a Class 2 device classified under 21 CFR 864.7750, reviewed by the Hematology panel.
510(k) review time for GJS
Across 14 510(k) clearances under GJS decided from 2018-01-01 to 2026-10-06, the median was 168 days from FDA receipt to decision. Half took between 41 and 345 days, and 80% were decided within 374 days. These are past clearances, not a forecast for a new submission.
| Fastest | 28 |
|---|---|
| 25th percentile | 41 |
| Median | 168 |
| 75th percentile | 345 |
| 80th percentile | 374 |
| 90th percentile | 489 |
| Slowest | 589 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
GJS in the public FDA record
| 510(k) clearances, all years | 127 |
|---|---|
| Device recalls | 73 |
Counts of records, not of devices or events. Adverse event reports for GJS are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite GJS
5 FDA recognized consensus standards cite GJS, among them ISO IEEE 11073-10418 First edition 2014-03-01; CLSI H21-A5; CLSI H47-A2. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 13-67 ISO IEEE 11073-10418 First edition 2014-03-01 — Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor [including TECHNICAL CORRIGENDUM 1 (2016)]
- 7-159 CLSI H21-A5 — Collection Transport and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays
- 7-205 CLSI H47-A2 — One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline - Second Edition.
- 7-277 CLSI GP41 7th Edition — Collection of Diagnostic Venous Blood Specimens
- 7-299 CLSI POCT14 2nd Edition — Point-of-Care Coagulation Testing and Anticoagulation Monitoring
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.