Cleared Special

K212427 - cobas Cdiff nucleic acid test for use o...

K212427 is the FDA 510(k) clearance for cobas Cdiff nucleic acid test for use o... by Roche Molecular Systems, Inc.. It is a Class 2 Microbiology device (product code OZN) cleared through the Special 510(k) pathway after a 77-day FDA review.

K212427 · Roche Molecular Systems, Inc. · Microbiology device
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Oct 2021
Decision
77d
Days
Class 2
Risk

K212427 is an FDA 510(k) clearance for the cobas Cdiff nucleic acid test for use on the cobas Liat System. 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 October 20, 2021 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3130 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Roche Molecular Systems, Inc. devices

Submission Details

510(k) Number K212427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2021
Decision Date October 20, 2021
Days to Decision 77 days
Submission Type Special
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
25d faster than avg
Panel avg: 102d · This submission: 77d
Pathway characteristics
Modification to existing cleared device.

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 8
Devices cleared under the same product code (OZN) and FDA review panel - the closest regulatory comparables to K212427.
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
K210385 · Roche Molecular Systems, Inc. · Sep 2021
cobas Cdiff Nucleic acid test for use on the cobas Liat System
K171770 · Roche Molecular Systems, Inc. · Sep 2017
Solana C. difficile Assay
K170491 · Quidel Corporation · May 2017
cobas Cdiff Test
K142422 · Roche Molecular Systems, Inc. · May 2015