510(k) Report

FDA applicant

Genepoc, Inc.

Quebec, CA5 decisions2017–20193 recalls

FDA records 5 decisions for Genepoc, Inc. (Quebec, CA) from 2017 to 2019: 5 510(k) clearances. Most are in product codes NJR (Nucleic Acid Amplification Assay System, Group…) and OZN (C. Difficile Toxin Gene Amplification Assay). Its devices cite 3 predicates, 0 of them its own earlier devices. 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Genepoc, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2017: 32019: 2
2017high 3 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2025

2022: 22025: 1
2017high 2 (2022) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Genepoc, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Genepoc, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NJRNucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test1decision
  • OZNC. Difficile Toxin Gene Amplification Assay1decision
  • PGXGroups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System1decision
  • OOIReal Time Nucleic Acid Amplification System1decision
  • PMYSystem, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative…1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K170557GenePOC GBS LBGenepoc, Inc. · 20171cites it
  • K172569GenePOC CDiffGenepoc, Inc. · 20171cites it
  • K170558revogeneGenepoc, Inc. · 20171cites it

What has FDA decided for it lately?

  • K190275GenePOC CarbaGenepoc, Inc. · 2019
  • K183366GenePOC Strep AGenepoc, Inc. · 2019
  • K172569GenePOC CDiffGenepoc, Inc. · 20171 recall
  • K170557GenePOC GBS LBGenepoc, Inc. · 2017
  • K170558revogeneGenepoc, Inc. · 20172 recalls

All 5 as Genepoc, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K172569Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene…Dec 5, 2025Class II
  • K170558Revogene, Catalog no. 610210. IVD test instrumentJun 22, 2022Class II
  • K170558Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical…Feb 15, 2022Class II