Cleared Traditional

K171605 - Elecsys CA 15-3 II

K171605 is an FDA 510(k) clearance for Elecsys CA 15-3 II, manufactured by Roche Diagnostics. The device is a Class 2 Immunology device with product code MOI cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K171605 · Roche Diagnostics · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
264d
Days
Class 2
Risk

K171605 is an FDA 510(k) clearance for the Elecsys CA 15-3 II. Classified as System, Test, Immunological, Antigen, Tumor (product code MOI), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on February 20, 2018 after a review of 264 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.

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FDA 510(k) Submission Details - K171605

510(k) Number K171605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2017
Decision Date February 20, 2018
Days to Decision 264 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
160d slower than avg
Panel avg: 104d · This submission: 264d
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 23
Devices cleared under the same product code (MOI) and FDA review panel - the closest regulatory comparables to K171605.
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
DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605
K100344 · Siemens Healthcare Diagnostics · Apr 2011
ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647
K072612 · Beckman Coulter, Inc. · Oct 2007
ARCHITECT CA 15-3 ASSAY
K042732 · Fujirebio Diagnostics,Inc. · Dec 2004