Cleared Traditional

K080017 - VIDAS AFP ASSAY

K080017 is the FDA 510(k) clearance for VIDAS AFP ASSAY by bioMerieux, Inc.. It is a Class 2 Immunology device (product code LOJ) cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K080017 · bioMerieux, Inc. · Immunology device
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Sep 2008
Decision
267d
Days
Class 2
Risk

K080017 is an FDA 510(k) clearance for the VIDAS AFP ASSAY. Classified as Kit, Test,alpha-fetoprotein For Testicular Cancer (product code LOJ), Class II - Special Controls.

Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on September 26, 2008 after a review of 267 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

Submission Details

510(k) Number K080017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2008
Decision Date September 26, 2008
Days to Decision 267 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
163d slower than avg
Panel avg: 104d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LOJ Kit, Test,alpha-fetoprotein For Testicular Cancer
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 - LOJ Kit, Test,alpha-fetoprotein For Testicular Cancer

All 12
Devices cleared under the same product code (LOJ) and FDA review panel - the closest regulatory comparables to K080017.
Elecsys AFP
K220176 · Roche Diagnostics · Sep 2022
VITROS AFP
K213626 · Ortho-Clinical Diagnostics · Jun 2022
DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454
K090236 · Siemens Healthcare Diagnostics · Apr 2009
DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600
K071597 · Dade Behring, Inc. · Jun 2008
ST AIA-PACK AFP ENZYME IMMUNOASSAY
K023894 · Tosoh Medics, Inc. · Dec 2002
ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY
K020806 · Bayer Corp. · Mar 2002