Brain Trauma Assessment Test
The Brain Trauma Assessment Test is an in vitro diagnostic device intended as an aid in the evaluation of patients with suspected mild traumatic brain injury (TBI), used in conjunction with other clinical information to assist in determining the need for radiologic head imaging per current standard of care. It is classified as a Class 2 device under regulation 866.5830, requiring 510(k) premarket notification and eligible for third-party review, falling within the Immunology (IM) medical specialty. The product code is QAT. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QAT
- Device Class
- FDA class 2
- Regulation Number
- 866.5830
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
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
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K240279 | VIDAS TBI (GFAP, UCH-L1) | May 01, 2024 | Substantially Equivalent | bioMerieux, Inc. |
| K234143 | i-STAT TBI Cartridge with the i-STAT Alinity System | Mar 27, 2024 | Substantially Equivalent | Abbott Point of Care |
| K232669 | TBI | Sep 29, 2023 | Substantially Equivalent | Abbott Laboratories |
| K223602 | Traumatic brain injury (TBI) test | Mar 02, 2023 | Substantially Equivalent | Abbott Laboratories |
| K201778 | i-STAT TBI Plasma cartridge with the i-STAT Alinity System | Jan 08, 2021 | Substantially Equivalent | Abbott Laboratories |
| DEN170045 | Banyan BTI | Feb 14, 2018 | Unknown | Banyan Biomarkers, Inc. |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.