QAT
6 FDA 510(k) clearances · Product code
90 daysmedian time to decision
192 days90th percentile
6clearances measured
FDA profile
- Official device name
- Brain Trauma Assessment Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5830
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- FDA 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
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| Record | Firm | Date |
|---|---|---|
| VIDAS TBI (GFAP, UCH-L1) (K240279) | bioMerieux, Inc. | 2024-05-01 |
| i-STAT TBI Cartridge with the i-STAT Alinity System (K234143) | Abbott Point of Care | 2024-03-27 |
| TBI (K232669) | Abbott Laboratories | 2023-09-29 |
| Traumatic brain injury (TBI) test (K223602) | Abbott Laboratories | 2023-03-02 |
| i-STAT TBI Plasma cartridge with the i-STAT Alinity System (K201778) | Abbott Laboratories | 2021-01-08 |
| Banyan BTI (DEN170045) | Banyan Biomarkers, Inc. | 2018-02-14 |
Track QAT automatically
Every clearance here is in the API, with alerts when new ones post.