Cleared Traditional

K240279 - VIDAS TBI (GFAP, UCH-L1) (FDA 510(k) Clearance)

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240279 · bioMerieux, Inc. · Immunology device
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May 2024
Decision
90d
Days
Class 2
Risk

K240279 is an FDA 510(k) clearance for the VIDAS TBI (GFAP, UCH-L1). Classified as Brain Trauma Assessment Test (product code QAT), Class II - Special Controls.

Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on May 1, 2024 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5830 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all bioMerieux, Inc. devices

Submission Details

510(k) Number K240279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2024
Decision Date May 01, 2024
Days to Decision 90 days
Submission Type Traditional
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
14d faster than avg
Panel avg: 104d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.