FDA Product Code QAT: Brain Trauma Assessment Test
Objective biomarkers for traumatic brain injury support faster and more accurate diagnosis. FDA product code QAT covers brain trauma assessment tests used as aids in the evaluation of TBI.
These blood-based immunoassays measure brain injury biomarkers — including GFAP and UCH-L1 — released into the circulation after brain trauma, providing an objective measure that can help guide CT scanning decisions in patients presenting with mild TBI or concussion.
QAT devices are Class II medical devices, regulated under 21 CFR 866.5830 and reviewed by the FDA Immunology panel.
Leading manufacturers include Abbott Laboratories and bioMerieux, Inc..
List of Brain Trauma Assessment Test devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Brain Trauma Assessment Test devices (product code QAT). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Immunology FDA review panel. Browse all Immunology devices →