# K201778: i-STAT TBI Plasma cartridge with the i-STAT Alinity System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jan 8, 2021 after 192 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: 1 generation back to DEN170045 (2018). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170045: Banyan BTI, Banyan Biomarkers, Inc. (2018) Summary page 6.

## Most influential descendants
- K234143: i-STAT TBI Cartridge with the i-STAT Alinity System (2024), 0 descendants of its own

## Indications for use
The i-STAT TBI Plasma test is a panel of in vitro diagnostic immunoassays for the quantitative measurements of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in plasma and a semiquantitative interpretation of test results derived from these measurements, using the i-STAT Alinity Instrument. 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 ‘Not Elevated’ test interpretation is associated with the absence of acute traumatic intracranial lesions visualized on a head CT scan. The test is to be used with plasma prepared from EDTA anticoagulated specimens in clinical laboratory settings by a healthcare professional. The i-STAT TBI Plasma test is not intended to be used in point of care settings.

Source page: https://510kreport.com/device/K201778
Methodology: https://510kreport.com/methodology