Cleared Traditional

K260045 - cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190)

Also marketed or referenced as:
cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190)

K260045 is an FDA 510(k) clearance for cobas Cdiff Nucleic acid test for use o..., 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 233-day FDA review.

K260045 · Roche Molecular Systems, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
233d
Days
Class 2
Risk

K260045 is an FDA 510(k) clearance for the cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190). 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 August 28, 2026 after a review of 233 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 - K260045

510(k) Number K260045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2026
Decision Date August 28, 2026
Days to Decision 233 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
131d slower than avg
Panel avg: 102d · This submission: 233d
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 17
Devices cleared under the same product code (OZN) and FDA review panel - the closest regulatory comparables to K260045.
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
GenePOC CDiff
K172569 · Genepoc, Inc. · Nov 2017
cobas Cdiff Nucleic acid test for use on the cobas Liat System
K171770 · Roche Molecular Systems, Inc. · Sep 2017