510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QATClass II

Brain Trauma Assessment Test

21 CFR 866.5830 / Immunology
FDA source (opens on fda.gov)

QAT is the FDA product code for Brain Trauma Assessment Test, a class II device type, regulated under 21 CFR 866.5830. FDA's definition for this code reads: "Intended for in vitro diagnostic use as an aid in the evaluation of patients with suspected mild traumatic brain injury (TBI) in conjunction with other clinical information to assist in determining the need for radiologic (e.g., CT, MR) head imaging per current standard of care". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QAT
Device name
Brain Trauma Assessment Test
FDA definition
Intended for in vitro diagnostic use as an aid in the evaluation of patients with suspected mild traumatic brain injury (TBI) in conjunction with other clinical information to assist in determining the need for radiologic (e.g., CT, MR) head imaging per current standard of care
Regulation
21 CFR 866.5830
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
6
Ingested recalls
0

Clearances, product code QAT

By decision year
6 clearances under product code QAT with a decision year between 2018 and 2024, 2023 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QAT by decision year
YearClearances
20181
20211
20232
20242

Applicants with the most clearances

Product code QAT
Applicants holding the most 510(k) clearances under product code QAT
ApplicantClearances
Abbott Medical4
Banyan Biomarkers, Inc.1
bioMerieux, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code