Vidas Tbi (Gfap, UCH-L1)
FDA 510(k) K240279 · bioMerieux, Inc.
510(k) numberK240279
Submission
- Device name
- Vidas Tbi (Gfap, UCH-L1)
- Applicant
- bioMerieux, Inc.
Hazelwood, MO, US - Received
- February 1, 2024
- Decision date
- May 1, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QAT – Brain Trauma Assessment Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5830
- Specialty
- 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
Other 510(k)s with product code QAT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Abbott Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K260160 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystemSAN · Traditional | 07/08/2026SE |
| K260282 | VITEK 2 AST-Streptococcus Inducible Clindamycin ResistanceLON · Traditional | 04/15/2026SE |
| K260281 | VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)LON · Traditional | 03/26/2026SE |
| K251579 | VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)LON · Traditional | 08/21/2025SE |
| K234012 | Vitek Compact ProLON · Traditional | 03/14/2025SE |
| K232967 | VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)NGZ · Traditional | 06/12/2024SE |
| K232963 | VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)NGZ · Traditional | 06/07/2024SE |
| K234000 | VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)LON · Traditional | 03/11/2024SE |
| K232201 | VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus…LON · Traditional | 10/23/2023SE |
| K230864 | VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin…LON · Traditional | 07/05/2023SE |
Questions and answers
When was Vidas Tbi (Gfap, UCH-L1) cleared by the FDA?
Vidas Tbi (Gfap, UCH-L1) (K240279) received a 510(k) decision of Substantially Equivalent on May 1, 2024, 90 days after the submission was received.
What is the product code of K240279?
The FDA product code is QAT – Brain Trauma Assessment Test, a Class II (moderate risk) device regulated under 21 CFR 866.5830.