TBI
FDA 510(k) clearance K232669 · decided 2023-09-29
Clearance details
- K-number
- K232669
- Device name
- TBI
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 2023-09-01
- Decision date
- 2023-09-29
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- QAT
- Device class
- 2
- Regulation number
- 866.5830
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Abbott Park, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |