Cleared Traditional

K020807 - AFP ASSAY FOR THE ADVIA INTEGRATED MODU...

K020807 is the FDA 510(k) clearance for AFP ASSAY FOR THE ADVIA INTEGRATED MODU... by Bayer Diagnostics Corp.. It is a Class 2 Immunology device (product code LOJ) cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K020807 · Bayer Diagnostics Corp. · Immunology device
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Oct 2002
Decision
203d
Days
Class 2
Risk

K020807 is an FDA 510(k) clearance for the AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM. Classified as Kit, Test,alpha-fetoprotein For Testicular Cancer (product code LOJ), Class II - Special Controls.

Submitted by Bayer Diagnostics Corp. (Tarrytown, US). The FDA issued a Cleared decision on October 1, 2002 after a review of 203 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 Bayer Diagnostics Corp. devices

Submission Details

510(k) Number K020807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2002
Decision Date October 01, 2002
Days to Decision 203 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 104d · This submission: 203d
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 13
Devices cleared under the same product code (LOJ) and FDA review panel - the closest regulatory comparables to K020807.
VIDAS AFP ASSAY
K080017 · bioMerieux, Inc. · Sep 2008
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
DSL ACTIVE AFP ELISA, MODEL DSL-10-8400
K990138 · Diagnostic Systems Laboratories, Inc. · Jun 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY
K983031 · Ortho-Clinical Diagnostics, Inc. · Dec 1998