Cleared Traditional

K012357 - CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM

K012357 is an FDA 510(k) clearance for CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM, manufactured by Bayer Diagnostics Corp.. The device is a Class 2 Immunology device with product code MOI cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K012357 · Bayer Diagnostics Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
218d
Days
Class 2
Risk

K012357 is an FDA 510(k) clearance for the CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM. Classified as System, Test, Immunological, Antigen, Tumor (product code MOI), Class II - Special Controls.

Submitted by Bayer Diagnostics Corp. (Tarrytown, US). The FDA issued a Cleared decision on February 28, 2002 after a review of 218 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

FDA 510(k) Submission Details - K012357

510(k) Number K012357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2001
Decision Date February 28, 2002
Days to Decision 218 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
113d slower than avg
Panel avg: 105d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOI Device Classification - Class 2, Special Controls

Product Code MOI System, Test, Immunological, Antigen, Tumor
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 - MOI System, Test, Immunological, Antigen, Tumor

All 24
Devices cleared under the same product code (MOI) and FDA review panel - the closest regulatory comparables to K012357.
BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647
K033036 · Beckman Coulter, Inc. · Feb 2004
CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K022178 · Bayer Diagnostics Corp. · Nov 2002
IMMULITE BR-MA, MODEL #LKBR
K013984 · Diagnostic Products Corp. · Mar 2002
AIA-PACK BRCA, ST AIA PACK BRCA
K010796 · Tosoh Medics, Inc. · Aug 2001
ELECSYSCA 15-3 II ASSAY
K010588 · Roche Diagnostics Corp. · Mar 2001
ELECSYS CA 15-3 TEST SYSTEM
K001468 · Roche Diagnostics Corp. · Oct 2000