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, Abbott Point of Care and bioMerieux, Inc..
FDA 510(k) Cleared Brain Trauma Assessment Test Devices (Product Code QAT)
About Product Code QAT - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code QAT since 2018, with 5 receiving FDA clearance (average review time: 110 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 4 in the prior period.
QAT devices are reviewed by the Immunology panel. Browse all Immunology devices →