# K232669: TBI

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories
- Decided: Sep 29, 2023 after 28 days
- Product code: QAT (Brain Trauma Assessment Test)
- Device class: 2
- Regulation: 21 CFR 866.5830
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN170045 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223602: Traumatic brain injury (TBI) test, Abbott Laboratories (2023) Summary page 4.

## Indications for use
The TBI test is a panel of in vitro diagnostic chemiluminescent microparticle immunoassays (CMIA) used for the quantitative measurements of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L 1 (UCH-L 1) in human plasma and serum and provides a semi-quantitative interpretation of test results derived from these measurements using the ARCHITECT i 100OSR System. The interpretation of test results is used, in conjunction with other clinical information, to aid in the evaluation of patients, 18 years of age or older, presenting with suspected mild traumatic brain injury (Glasgow Coma Scale score 13-15) within 12 hours of injury, to assist in determining the need for a CT (computed tomography) scan of the head. A negative test result is associated with the absence of acute intracranial lesions visualized on a head CT scan. The TBI test is intended for use in clinical laboratory settings by healthcare professionals.

Source page: https://510kreport.com/device/K232669
Methodology: https://510kreport.com/methodology