Cleared Traditional

K001468 - ELECSYS CA 15-3 TEST SYSTEM

K001468 is an FDA 510(k) clearance for ELECSYS CA 15-3 TEST SYSTEM, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Immunology device with product code MOI cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K001468 · Roche Diagnostics Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
166d
Days
Class 2
Risk

K001468 is an FDA 510(k) clearance for the ELECSYS CA 15-3 TEST SYSTEM. Classified as System, Test, Immunological, Antigen, Tumor (product code MOI), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on October 23, 2000 after a review of 166 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 Roche Diagnostics Corp. devices

FDA 510(k) Submission Details - K001468

510(k) Number K001468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2000
Decision Date October 23, 2000
Days to Decision 166 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
61d slower than avg
Panel avg: 105d · This submission: 166d
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 K001468.
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ELECSYSCA 15-3 II ASSAY
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K983690 · Ortho-Clinical Diagnostics, Inc. · Feb 1999
CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY
K982680 · Chiron Diagnostics Corp. · Oct 1998
THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K964703 · Bayer Corp. · Dec 1997