Cleared Traditional

Great Basin Toxigenic C. difficile Direct Test (CDF2)

K232092 · Vela Operations USA · Microbiology

Nov 2023

Decision

124d

Days

Class 2

Risk

About This 510(k) Submission

K232092 is an FDA 510(k) clearance for the Great Basin Toxigenic C. difficile Direct Test (CDF2), a C. Difficile Toxin Gene Amplification Assay (Class II — Special Controls, product code OZN), submitted by Vela Operations USA (Salt Lake City, US). The FDA issued a Cleared decision on November 14, 2023, 124 days after receiving the submission on July 13, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3130.

Submission Details

510(k) Number	K232092 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	OZN — C. Difficile Toxin Gene Amplification Assay
Device Class	Class II — 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.