FDA product code GJA: Test, Thrombin Time
GJA is the FDA product code for test, thrombin time. It is a Class II device, regulated under 21 CFR 864.7875 and reviewed by the Hematology panel. FDA has cleared 20 510(k) submissions under GJA, from 14 different applicants. The average 510(k) review took 103 days (median 80). FDA has posted 4 recalls for GJA devices.
Classification
| Field | Value |
|---|---|
| Device name | Test, Thrombin Time |
| Device class | Class II |
| Regulation | 21 CFR 864.7875 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GJA clearance
Top GJA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio/Data Corp. | 3 | 1985-03-26 |
| General Diagnostics | 3 | 1980-09-26 |
| Behring Diagnostics, Inc. | 2 | 1997-05-19 |
| American Bioproducts Co. | 2 | 1988-12-28 |
| R2 Diagnostics, Inc. | 1 | 2005-12-12 |
9 more applicants have GJA clearances. See the full list in Caduvo.
Most recent GJA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K050817 | R2 Diagnostics, Inc. | T-TEK | 2005-12-12 | 256 |
| K982209 | Sigma Diagnostics, Inc. | ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 | 1998-10-15 | 114 |
| K970645 | Behring Diagnostics, Inc. | BC THROMBIN REAGENT | 1997-05-19 | 88 |
| K925493 | Biomerieux Vitek, Inc. | BIOMERIEUX HEMOLAB THROMBICALCI-TEST | 1994-04-21 | 535 |
| K930157 | Behring Diagnostics, Inc. | TEST THROMBIN | 1993-05-14 | 121 |
Recalls for GJA devices
4 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-10-17.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code GJA?
GJA is the FDA product code for test, thrombin time. It is a Class II device, regulated under 21 CFR 864.7875 and reviewed by the Hematology panel.
What device class is GJA?
Class II, regulation 21 CFR 864.7875. Typical premarket route: 510(k).
How long does a 510(k) take for product code GJA?
Across 20 cleared submissions the average was 103 days from receipt to decision (median 80).
Which companies have the most GJA clearances?
Bio/Data Corp. (3); General Diagnostics (3); Behring Diagnostics, Inc. (2); American Bioproducts Co. (2); R2 Diagnostics, Inc. (1).
Have GJA devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2017-10-17.
Next steps
- Run an FDA pathway report with predicate devices for product code GJA
- Run a recall and safety report across every GJA manufacturer
- Watch product code GJA 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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