Cleared Traditional

K080194 - VIDAS CEA (S) ASSAY

K080194 is an FDA 510(k) clearance for VIDAS CEA (S) ASSAY, manufactured by bioMerieux, Inc.. The device is a Class 2 Immunology device with product code DHX cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K080194 · bioMerieux, Inc. · Immunology device
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Oct 2008
Decision
258d
Days
Class 2
Risk

K080194 is an FDA 510(k) clearance for the VIDAS CEA (S) ASSAY. Classified as System, Test, Carcinoembryonic Antigen (product code DHX), Class II - Special Controls.

Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on October 9, 2008 after a review of 258 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - 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

FDA 510(k) Submission Details - K080194

510(k) Number K080194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2008
Decision Date October 09, 2008
Days to Decision 258 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
153d slower than avg
Panel avg: 105d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHX Device Classification - Class 2, Special Controls

Product Code DHX System, Test, Carcinoembryonic Antigen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
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 - DHX System, Test, Carcinoembryonic Antigen

All 23
Devices cleared under the same product code (DHX) and FDA review panel - the closest regulatory comparables to K080194.
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K031270 · Beckman Coulter, Inc. · May 2003