Cleared Traditional

Elecsys CA 15-3 II (K181492) - FDA 510(k) Clearance

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

K181492 · Roche Diagnostics · Immunology device
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Jun 2018
Decision
16d
Days
Class 2
Risk

K181492 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 June 22, 2018 after a review of 16 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K181492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2018
Decision Date June 22, 2018
Days to Decision 16 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
88d faster than avg
Panel avg: 104d · This submission: 16d
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 K181492.
Lumipulse G CA15-3
K192524 · Fujirebio Diagnostics,Inc. · Sep 2020
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
K171605 · Roche Diagnostics · Feb 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