QAT · Class II · 21 CFR 866.5830

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, Banyan Biomarkers, Inc. and Abbott Point of Care.

6
Total
5
Cleared
110d
Avg days
2018
Since
Declining activity - 0 submissions in the last 2 years vs 4 in the prior period

FDA 510(k) Cleared Brain Trauma Assessment Test Devices (Product Code QAT)

6 devices
1–6 of 6
Cleared May 01, 2024
VIDAS TBI (GFAP, UCH-L1)
K240279
bioMerieux, Inc.
Immunology · 90d
Cleared Mar 27, 2024
i-STAT TBI Cartridge with the i-STAT Alinity System
K234143
Abbott Point of Care
Immunology · 89d
Cleared Sep 29, 2023
TBI
K232669
Abbott Laboratories
Immunology · 28d
Cleared Mar 02, 2023
Traumatic brain injury (TBI) test
K223602
Abbott Laboratories
Immunology · 90d
Cleared Jan 08, 2021
i-STAT TBI Plasma cartridge with the i-STAT Alinity System
K201778
Abbott Laboratories
Immunology · 192d
Not Cleared Feb 14, 2018
Banyan BTI
DEN170045
Banyan Biomarkers, Inc.
Immunology · 170d

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.