Cleared Traditional

ELECSYS CA 15-3 TEST SYSTEM (K001468) - FDA 510(k) Clearance

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

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
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 27
Devices cleared under the same product code (MOI) and FDA review panel - the closest regulatory comparables to K001468.
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ADVIA Centaur BR
K193489 · Siemens Healthcare Diagnostics, Inc. · Feb 2020
ADVIA Centaur CA 15-3 assay
K192777 · Siemens Healthcare Diagnostics, Inc. · Nov 2019
Elecsys CA 15-3 II
K181492 · Roche Diagnostics · Jun 2018