Cleared Traditional

K001468 - ELECSYS CA 15-3 TEST SYSTEM

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

K001468 · Roche Diagnostics Corp. · Immunology device
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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

Submission Details

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
62d slower than avg
Panel avg: 104d · This submission: 166d
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 16
Devices cleared under the same product code (MOI) and FDA review panel - the closest regulatory comparables to K001468.
BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647
K033036 · Beckman Coulter, Inc. · Feb 2004
IMMULITE BR-MA, MODEL #LKBR
K013984 · Diagnostic Products Corp. · Mar 2002
ELECSYSCA 15-3 II ASSAY
K010588 · Roche Diagnostics Corp. · Mar 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK
K983690 · Ortho-Clinical Diagnostics, Inc. · Feb 1999
THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K964703 · Bayer Corp. · Dec 1997
IMX CA 15-3
K964407 · Abbott Laboratories · Nov 1997