510(k) Report

FDA applicant

DNA Genotek, Inc.

Ottawa, CA8 decisions2011–20261 recall

FDA records 8 decisions for DNA Genotek, Inc. (Ottawa, CA) from 2011 to 2026: 7 510(k) clearances and 1 De Novo grant. Most are in product codes OYJ (Dna Specimen Collection, Saliva) and QPO (Device To Preserve And Stabilize Relative…). Its devices cite 9 predicates, 7 of them its own earlier devices. 1 recall is linked to its devices.

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

FIG. A — Illustration, clinical chemistry panel, where it files most

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

FDA decisions per year

1in 2022

2011: 12015: 12016: 22020: 12021: 12022: 12026 (partial year): 1
2011high 2 (2016) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2022

2022: 1
2011high 1 (2022) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — DNA Genotek, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like DNA Genotek, 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?

  • OYJDna Specimen Collection, Saliva6decisions
  • QPODevice To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In…1decision
  • SIHDevice For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared…1decision

Whose devices does it build on?

Its devices cite 9 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 7 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.

  • K110701Oragene-DX Ogd-500; Oragene-DX Ogd-575; Oragene-DX Oxd-525; Oragene-DX Oyd-500DNA Genotek, Inc. · 20114cite it
  • K141410Oragene DX Ogd-500.001DNA Genotek, Inc. · 20152cite it
  • K192920Oragene®•DxDNA Genotek, Inc. · 20201cites it
  • K152556Oragene DxDNA Genotek, Inc. · 20161cites it

What has FDA decided for it lately?

  • K254121Colli-Pee•Dx Urine Collection KitDNA Genotek, Inc. · 2026
  • K212745ORAcollect®•DxDNA Genotek, Inc. · 2022
  • DEN200040OMNIgene GUT DxDNA Genotek, Inc. · 2021
  • K192920Oragene®•DxDNA Genotek, Inc. · 2020
  • K152464ORAcollect.DxDNA Genotek, Inc. · 20161 recall
  • K152556Oragene DxDNA Genotek, Inc. · 2016
  • K141410Oragene DX Ogd-500.001DNA Genotek, Inc. · 2015
  • K110701Oragene-DX Ogd-500; Oragene-DX Ogd-575; Oragene-DX Oxd-525; Oragene-DX Oyd-500DNA Genotek, Inc. · 2011

All 8 as DNA Genotek, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K152464ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100…Feb 18, 2022Class II