Cleared Special

K232669 - TBI (FDA 510(k) Clearance)

Class II Immunology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K232669 · Abbott Laboratories · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
28d
Days
Class 2
Risk

K232669 is an FDA 510(k) clearance for the TBI. Classified as Brain Trauma Assessment Test (product code QAT), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on September 29, 2023 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5830 - the FDA immunology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K232669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 104d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QAT Brain Trauma Assessment Test
Device Class Class 2 - 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
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - QAT Brain Trauma Assessment Test

Devices cleared under the same product code (QAT) and FDA review panel - the closest regulatory comparables to K232669.
VIDAS TBI (GFAP, UCH-L1)
K240279 · bioMerieux, Inc. · May 2024
i-STAT TBI Cartridge with the i-STAT Alinity System
K234143 · Abbott Point of Care · Mar 2024
Traumatic brain injury (TBI) test
K223602 · Abbott Laboratories · Mar 2023
i-STAT TBI Plasma cartridge with the i-STAT Alinity System
K201778 · Abbott Laboratories · Jan 2021