Brain Trauma Assessment Test
FDA product code QAT · Class II (moderate risk) · 21 CFR 866.5830 · Immunology
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
5510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240279 | Vidas Tbi (Gfap, UCH-L1)QAT · Traditional | bioMerieux, Inc. | 05/01/2024SE |
| K234143 | i-STAT TBI Cartridge with the i-STAT Alinity SystemQAT · Traditional | Abbott Point of Care | 03/27/2024SE |
| K232669 | TbiQAT · Special | Abbott Laboratories | 09/29/2023SE |
| K223602 | Traumatic brain injury (TBI) testQAT · Traditional | Abbott Laboratories | 03/02/2023SE |
| K201778 | i-STAT TBI Plasma cartridge with the i-STAT Alinity SystemQAT · Traditional | Abbott Laboratories | 01/08/2021SE |