Cleared Traditional

CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM (K012357) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K012357 · Bayer Diagnostics Corp. · Immunology device
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 104d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 27
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