QAT — Brain Trauma Assessment Test Class II
FDA product code QAT covers "Brain Trauma Assessment Test", a Class II medical device regulated under 21 CFR 866.5830. Submissions are reviewed by the Immunology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QAT
- Device Class
- Class II
- Regulation Number
- 866.5830
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
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
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K240279 | biomerieux | VIDAS TBI (GFAP, UCH-L1) | May 1, 2024 |
| K234143 | abbott point of care | i-STAT TBI Cartridge with the i-STAT Alinity System | March 27, 2024 |
| K232669 | abbott laboratories | TBI | September 29, 2023 |
| K223602 | abbott laboratories | Traumatic brain injury (TBI) test | March 2, 2023 |
| K201778 | abbott laboratories | i-STAT TBI Plasma cartridge with the i-STAT Alinity System | January 8, 2021 |
| DEN170045 | banyan biomarkers | Banyan BTI | February 14, 2018 |