FDA product code QAT: Brain Trauma Assessment Test
QAT is the FDA product code for brain trauma assessment test. It is a Class II device, regulated under 21 CFR 866.5830 and reviewed by the Immunology panel. FDA has cleared 5 510(k) submissions under QAT, 4 in the last five years, from 3 different applicants. The average 510(k) review took 98 days (median 90); 90 days on average over the last three years. 1 De Novo request was granted under it.
Definition
Intended for in vitro diagnostic use as an aid in the evaluation of patients with suspected mild traumatic brain injury (TBI) in conjunction with other clinical information to assist in determining the need for radiologic (e.g., CT, MR) head imaging per current standard of care
Classification
| Field | Value |
|---|---|
| Device name | Brain Trauma Assessment Test |
| Device class | Class II |
| Regulation | 21 CFR 866.5830 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for QAT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 192 |
| 2023 | 2 | 59 |
| 2024 | 2 | 90 |
Compare with all 510(k) review times · Search every QAT clearance
Top QAT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 3 | 2023-09-29 |
| bioMerieux, Inc. | 1 | 2024-05-01 |
| Abbott Point of Care | 1 | 2024-03-27 |
Most recent QAT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240279 | bioMerieux, Inc. | VIDAS TBI (GFAP, UCH-L1) | 2024-05-01 | 90 |
| K234143 | Abbott Point of Care | i-STAT TBI Cartridge with the i-STAT Alinity System | 2024-03-27 | 89 |
| K232669 | Abbott Laboratories | TBI | 2023-09-29 | 28 |
| K223602 | Abbott Laboratories | Traumatic brain injury (TBI) test | 2023-03-02 | 90 |
| K201778 | Abbott Laboratories | i-STAT TBI Plasma cartridge with the i-STAT Alinity System | 2021-01-08 | 192 |
Recalls for QAT devices
openFDA lists no recalls for product code QAT.
Frequently asked questions
What is FDA product code QAT?
QAT is the FDA product code for brain trauma assessment test. It is a Class II device, regulated under 21 CFR 866.5830 and reviewed by the Immunology panel.
What device class is QAT?
Class II, regulation 21 CFR 866.5830. Typical premarket route: 510(k).
How long does a 510(k) take for product code QAT?
Across 5 cleared submissions the average was 98 days from receipt to decision (median 90).
Which companies have the most QAT clearances?
Abbott Laboratories (3); bioMerieux, Inc. (1); Abbott Point of Care (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QAT
- Run a recall and safety report across every QAT manufacturer
- Watch product code QAT 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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