Cleared Traditional

Traumatic brain injury (TBI) test

K223602 · Abbott Laboratories · Immunology

Mar 2023

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K223602 is an FDA 510(k) clearance for the Traumatic brain injury (TBI) test, a Brain Trauma Assessment Test (Class II — Special Controls, product code QAT), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 2, 2023, 90 days after receiving the submission on December 2, 2022. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5830.

Submission Details

510(k) Number	K223602 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 02, 2022
Decision Date	March 02, 2023
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

Product Code	QAT — Brain Trauma Assessment Test
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5830
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