Cleared Traditional

K963803 - CENTOCOR CA 15-3 RIA MODEL NO. 800-033

K963803 is an FDA 510(k) clearance for CENTOCOR CA 15-3 RIA MODEL NO. 800-033, manufactured by Centocor, Inc.. The device is a Class 2 Immunology device with product code MOI cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K963803 · Centocor, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
242d
Days
Class 2
Risk

K963803 is an FDA 510(k) clearance for the CENTOCOR CA 15-3 RIA MODEL NO. 800-033. Classified as System, Test, Immunological, Antigen, Tumor (product code MOI), Class II - Special Controls.

Submitted by Centocor, Inc. (Malvern, US). The FDA issued a Cleared decision on May 23, 1997 after a review of 242 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 Centocor, Inc. devices

FDA 510(k) Submission Details - K963803

510(k) Number K963803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1996
Decision Date May 23, 1997
Days to Decision 242 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
137d slower than avg
Panel avg: 105d · This submission: 242d
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 K963803.
AXSYM CA 15-3
K963926 · Abbott Laboratories · Sep 1997
ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)
K970695 · Chiron Diagnostics Corp. · Aug 1997
CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER
K971418 · Chiron Diagnostics Corp. · Jul 1997