Cleared Special

TBI

K232669 · Abbott Laboratories · Immunology

Sep 2023

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K232669 is an FDA 510(k) clearance for the TBI, 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 September 29, 2023, 28 days after receiving the submission on September 1, 2023. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5830.

Submission Details

510(k) Number	K232669 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 01, 2023
Decision Date	September 29, 2023
Days to Decision	28 days
Submission Type	Special
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