Cleared Traditional

K142422 - cobas Cdiff Test

K142422 is an FDA 510(k) clearance for cobas Cdiff Test, manufactured by Roche Molecular Systems, Inc.. The device is a Class 2 Microbiology device with product code OZN cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K142422 · Roche Molecular Systems, Inc. · Microbiology device
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May 2015
Decision
265d
Days
Class 2
Risk

K142422 is an FDA 510(k) clearance for the cobas Cdiff Test. Classified as C. Difficile Toxin Gene Amplification Assay (product code OZN), Class II - Special Controls.

Submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Cleared decision on May 20, 2015 after a review of 265 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3130 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Roche Molecular Systems, Inc. devices

FDA 510(k) Submission Details - K142422

510(k) Number K142422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2014
Decision Date May 20, 2015
Days to Decision 265 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 102d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OZN Device Classification - Class 2, Special Controls

Product Code OZN C. Difficile Toxin Gene Amplification Assay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3130
Definition Amplification Assay For The Detection Of C. Difficile Toxin Genes From Stool Specimens Of Symptomatic Patients.
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 Microbiology devices follow this clearance model.

Regulatory Peers - OZN C. Difficile Toxin Gene Amplification Assay

All 16
Devices cleared under the same product code (OZN) and FDA review panel - the closest regulatory comparables to K142422.
cobas Cdiff Nucleic acid test for use on the cobas Liat System
K171770 · Roche Molecular Systems, Inc. · Sep 2017
ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit
K171441 · Luminex Corporation · Jul 2017
Solana C. difficile Assay
K170491 · Quidel Corporation · May 2017
ARTUS C. DIFFICILE QS-RGQ MDX KIT
K133936 · QIAGEN GmbH · Apr 2014
ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM
K132726 · Primeradx · Nov 2013
IMDX C.DIFFICILE FOR ABBOTT M2000
K132235 · Intelligent Medical Devices, Inc. · Oct 2013