Cleared Traditional

K964703 - THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)

K964703 is an FDA 510(k) clearance for THE CA 15-3 ASSAY FOR THE TECHNICON IMM..., manufactured by Bayer Corp.. The device is a Class 2 Immunology device with product code MOI cleared through the Traditional 510(k) pathway after a 374-day FDA review.

K964703 · Bayer Corp. · Immunology device
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Dec 1997
Decision
374d
Days
Class 2
Risk

K964703 is an FDA 510(k) clearance for the THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM). Classified as System, Test, Immunological, Antigen, Tumor (product code MOI), Class II - Special Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on December 1, 1997 after a review of 374 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Corp. devices

FDA 510(k) Submission Details - K964703

510(k) Number K964703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1996
Decision Date December 01, 1997
Days to Decision 374 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
269d slower than avg
Panel avg: 105d · This submission: 374d
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 27
Devices cleared under the same product code (MOI) and FDA review panel - the closest regulatory comparables to K964703.
CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY
K982680 · Chiron Diagnostics Corp. · Oct 1998
ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)
K981698 · Chiron Corp. · Jul 1998
ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM)
K980190 · Chiron Corp. · Mar 1998
IMX CA 15-3
K964407 · Abbott Laboratories · Nov 1997
TRUQUANT BR RIA
K965141 · Biomira USA, Inc. · Oct 1997
AXSYM CA 15-3
K963926 · Abbott Laboratories · Sep 1997