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510(k) K232092

Great Basin Toxigenic C. difficile Direct Test (CDF2) by Vela Operations USA — Product Code OZN

K232092 is an FDA 510(k) premarket notification submitted by Vela Operations USA for the device "Great Basin Toxigenic C. difficile Direct Test (CDF2)". The FDA issued a decision of Substantially Equivalent on November 14, 2023. The device falls under product code OZN (C. Difficile Toxin Gene Amplification Assay), a Class II device regulated under 21 CFR 866.3130.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2023
Date Received
July 13, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
C. Difficile Toxin Gene Amplification Assay
Device Class
Class II
Regulation Number
866.3130
Review Panel
MI
Submission Type

Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients.

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  • K172569 — GenePOC CDiff (November 22, 2017)
  • K171770 — cobas Cdiff Nucleic acid test for use on the cobas Liat System (September 12, 2017)
  • K171441 — ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Ki (July 21, 2017)
  • K170491 — Solana C. difficile Assay (May 11, 2017)
  • K163085 — Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack (February 14, 2017)
  • K142422 — cobas Cdiff Test (May 20, 2015)
  • K133936 — ARTUS C. DIFFICILE QS-RGQ MDX KIT (April 4, 2014)

FDA data resources