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510(k) K172569

GenePOC CDiff by Genepoc, Inc. — Product Code OZN

K172569 is an FDA 510(k) premarket notification submitted by Genepoc, Inc. for the device "GenePOC CDiff". The FDA issued a decision of Substantially Equivalent on November 22, 2017. The device falls under product code OZN (C. Difficile Toxin Gene Amplification Assay), a Class II device regulated under 21 CFR 866.3130. Genepoc, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2017
Date Received
August 25, 2017
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.

Other clearances by Genepoc, Inc.

  • K190275 — GenePOC Carba (May 10, 2019)
  • K183366 — GenePOC Strep A (March 6, 2019)
  • K170558 — revogene (May 25, 2017)
  • K170557 — GenePOC GBS LB (May 25, 2017)

Other clearances for product code OZN

  • K243730 — Xpert C. difficile/Epi (February 28, 2025)
  • K232092 — Great Basin Toxigenic C. difficile Direct Test (CDF2) (November 14, 2023)
  • K212427 — cobas Cdiff nucleic acid test for use on the cobas Liat System (October 20, 2021)
  • K210385 — cobas Cdiff nucleic acid test for use on the cobas Liat System (September 9, 2021)
  • 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