Cleared Special

K020806 - ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY

K020806 is an FDA 510(k) clearance for ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY, manufactured by Bayer Corp.. The device is a Class 2 Immunology device with product code LOJ cleared through the Special 510(k) pathway after a 15-day FDA review.

K020806 · Bayer Corp. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
15d
Days
Class 2
Risk

K020806 is an FDA 510(k) clearance for the ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY. Classified as Kit, Test,alpha-fetoprotein For Testicular Cancer (product code LOJ), Class II - Special Controls.

Submitted by Bayer Corp. (Medfield, US). The FDA issued a Cleared decision on March 27, 2002 after a review of 15 days - a notably fast clearance cycle.

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

FDA 510(k) Submission Details - K020806

510(k) Number K020806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2002
Decision Date March 27, 2002
Days to Decision 15 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
90d faster than avg
Panel avg: 105d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

LOJ Device Classification - Class 2, Special Controls

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 16
Devices cleared under the same product code (LOJ) and FDA review panel - the closest regulatory comparables to K020806.
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
AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K020807 · Bayer Diagnostics Corp. · Oct 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
IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2
K983263 · Diagnostic Products Corp. · Dec 1998
K020806 · ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY
Download PDF FDA Summary Bayer Corp.