FDA product code GJS: Test, Time, Prothrombin
GJS is the FDA product code for test, time, prothrombin. It is a Class II device, regulated under 21 CFR 864.7750 and reviewed by the Hematology panel. FDA has cleared 127 510(k) submissions under GJS, 9 in the last five years, from 55 different applicants. The average 510(k) review took 137 days (median 87); 211 days on average over the last three years. FDA has posted 73 recalls for GJS devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Test, Time, Prothrombin |
| Device class | Class II |
| Regulation | 21 CFR 864.7750 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
510(k) clearances per year for GJS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 269 |
| 2018 | 2 | 34 |
| 2019 | 2 | 198 |
| 2020 | 1 | 231 |
| 2022 | 3 | 429 |
| 2023 | 2 | 278 |
| 2024 | 1 | 358 |
| 2025 | 3 | 64 |
Compare with all 510(k) review times · Search every GJS clearance
Top GJS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Instrumentation Laboratory CO | 11 | 2022-08-16 |
| International Technidyne Corp. | 8 | 2001-07-02 |
| Roche Diagnostics | 7 | 2025-10-24 |
| Roche Diagnostics Corp. | 7 | 2010-03-05 |
| Helena Laboratories | 6 | 1995-10-20 |
50 more applicants have GJS clearances. See the full list in Caduvo.
Most recent GJS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253188 | Roche Diagnostics | CoaguChek XS Plus System | 2025-10-24 | 28 |
| K251564 | Iline Microsystems, S.L. | microINR System | 2025-07-21 | 60 |
| K243543 | Iline Microsystems, S.L. | microINR System | 2025-02-27 | 104 |
| K230802 | Universal Biosensors Pty, Ltd. | Xprecia Prime Coagulation System | 2024-03-15 | 358 |
| K220282 | Abbott Laboratories | i-STAT PTplus Cartridge with the i-STAT 1 System | 2023-07-14 | 528 |
Recalls for GJS devices
73 product recalls in 45 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2025-03-06.
| Year | Recalls |
|---|---|
| 2017 | 5 |
| 2018 | 5 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 2 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code GJS?
GJS is the FDA product code for test, time, prothrombin. It is a Class II device, regulated under 21 CFR 864.7750 and reviewed by the Hematology panel.
What device class is GJS?
Class II, regulation 21 CFR 864.7750. Typical premarket route: 510(k).
How long does a 510(k) take for product code GJS?
Across 127 cleared submissions the average was 137 days from receipt to decision (median 87).
Which companies have the most GJS clearances?
Instrumentation Laboratory CO (11); International Technidyne Corp. (8); Roche Diagnostics (7); Roche Diagnostics Corp. (7); Helena Laboratories (6).
Have GJS devices been recalled?
Yes: 73 product recalls across 45 recall events; the most recent began 2025-03-06.
Next steps
- Run an FDA pathway report with predicate devices for product code GJS
- Run a recall and safety report across every GJS manufacturer
- Watch product code GJS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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