Cleared Traditional

K143534 - Elecsys CA-125 II assay

K143534 is an FDA 510(k) clearance for Elecsys CA-125 II assay, manufactured by Roche Professional Diagnostics. The device is a Class 2 Immunology device with product code LTK cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K143534 · Roche Professional Diagnostics · Immunology device
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Optimized for regulatory review, auditing and printing
Aug 2015
Decision
237d
Days
Class 2
Risk

K143534 is an FDA 510(k) clearance for the Elecsys CA-125 II assay. Classified as Test, Epithelial Ovarian Tumor-associated Antigen (ca125) (product code LTK), Class II - Special Controls.

Submitted by Roche Professional Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on August 6, 2015 after a review of 237 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 Professional Diagnostics devices

FDA 510(k) Submission Details - K143534

510(k) Number K143534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2014
Decision Date August 06, 2015
Days to Decision 237 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
132d slower than avg
Panel avg: 105d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LTK Device Classification - Class 2, Special Controls

Product Code LTK Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
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 - LTK Test, Epithelial Ovarian Tumor-associated Antigen (ca125)

All 24
Devices cleared under the same product code (LTK) and FDA review panel - the closest regulatory comparables to K143534.
IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA
K213510 · Siemens Healthcare Diagnostics Products, Ltd. · Sep 2023
VITROS Immuodiagnostic Products CA 125 II Reagent Pack
K221355 · Ortho-Clinical Diagnostics · Dec 2022
ADVIA Centaur CA 125II
K200199 · Siemens Healthcare Diagnostics, Inc. · Apr 2020
LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators
K142895 · Fujirebio Diagnostics,Inc. · May 2015
DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604
K100321 · Siemens Healthcare Diagnostics · Apr 2011
VIDAS CA 15-3 ASSAY
K080469 · bioMerieux, Inc. · Jun 2009