Cleared Traditional

K142422 - cobas Cdiff Test (FDA 510(k) Clearance)

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

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

Submission Details

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
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.

Device Classification

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.
Xpert C. difficile/Epi
K243730 · Cepheid · Feb 2025
Great Basin Toxigenic C. difficile Direct Test (CDF2)
K232092 · Vela Operations USA · Nov 2023
cobas Cdiff nucleic acid test for use on the cobas Liat System
K212427 · Roche Molecular Systems, Inc. · Oct 2021
cobas Cdiff nucleic acid test for use on the cobas Liat System
K210385 · Roche Molecular Systems, Inc. · Sep 2021