Cleared Traditional

K232092 - Great Basin Toxigenic C. difficile Dire...

K232092 is an FDA 510(k) clearance for Great Basin Toxigenic C. difficile Dire..., manufactured by Vela Operations USA. The device is a Class 2 Microbiology device with product code OZN cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K232092 · Vela Operations USA · Microbiology device
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Nov 2023
Decision
124d
Days
Class 2
Risk

K232092 is an FDA 510(k) clearance for the Great Basin Toxigenic C. difficile Direct Test (CDF2). Classified as C. Difficile Toxin Gene Amplification Assay (product code OZN), Class II - Special Controls.

Submitted by Vela Operations USA (Salt Lake City, US). The FDA issued a Cleared decision on November 14, 2023 after a review of 124 days - within the typical 510(k) review window.

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 Vela Operations USA devices

FDA 510(k) Submission Details - K232092

510(k) Number K232092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2023
Decision Date November 14, 2023
Days to Decision 124 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
22d slower than avg
Panel avg: 102d · This submission: 124d
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 8
Devices cleared under the same product code (OZN) and FDA review panel - the closest regulatory comparables to K232092.
Xpert C. difficile/Epi
K243730 · Cepheid · Feb 2025
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
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