DNA Genotek, Inc.: FDA clearances and approvals
DNA Genotek, Inc. has 7 FDA 510(k) clearances (first 2011, latest 2026), plus 1 De Novo decision, across 3 product codes in 2 review panels. Median 510(k) review time: 263 days. Since 2017 its median was 173 days, against 236 days for all cleared 510(k)s in the same product codes. openFDA lists 3 product recalls by a recalling firm named DNA Genotek, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 266 |
| 2016 | 2 | 265 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 90 |
| 2021 | 0 | — |
| 2022 | 1 | 423 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 173 |
Review time against the same product codes
Since 2017, DNA Genotek, Inc.'s cleared 510(k)s took a median 173 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 236 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OYJ | Dna Specimen Collection, Saliva | 6 | 6 |
| QPO | Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples | 1 | 0 |
| SIH | Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay | 1 | 1 |
Review panels
- Clinical Chemistry (6)
- Microbiology (2)
Most recent DNA Genotek, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254121 | Colli-PeeDx Urine Collection Kit | SIH | 2026-06-10 | 173 |
| K212745 | ORAcollect®Dx | OYJ | 2022-10-27 | 423 |
| K192920 | Oragene®Dx | OYJ | 2020-01-14 | 90 |
| K152556 | Oragene Dx | OYJ | 2016-05-26 | 261 |
| K152464 | ORAcollect.Dx | OYJ | 2016-05-26 | 269 |
| K141410 | ORAGENE DX OGD-500.001 | OYJ | 2015-02-19 | 266 |
| K110701 | ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 | OYJ | 2011-12-02 | 263 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN200040 | De Novo | Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples | 2021-11-03 |
Recalls
3 product recalls in 2 recall events; 2 initiated in the last five years. Most recent: 2022-02-18.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does DNA Genotek, Inc. have?
DNA Genotek, Inc. has 7 FDA 510(k) clearances (first 2011, latest 2026), plus 1 De Novo decision, across 3 product codes in 2 review panels.
How long does FDA take to clear DNA Genotek, Inc.'s 510(k)s?
The median time from FDA receipt to decision across DNA Genotek, Inc.'s cleared 510(k)s is 263 days. Since 2017: 173 days, versus 236 days for all cleared 510(k)s in the same product codes.
What devices does DNA Genotek, Inc. make?
Its most frequent FDA product codes are OYJ (Dna Specimen Collection, Saliva, 6); QPO (Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples, 1); SIH (Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay, 1).
Has DNA Genotek, Inc. had device recalls?
openFDA lists 3 product recalls in 2 recall events by a recalling firm whose name matches DNA Genotek, Inc; the most recent began 2022-02-18. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 7 DNA Genotek, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OYJ, DNA Genotek, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.