510(k) · Cleared
ClearedOragene Dx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DNA Genotek, Inc. · OYJ Dna Specimen Collection, Saliva
Cleared on May 26, 2016 as substantially equivalent to K110701 (DNA Genotek, Inc., 2011) after a 261-day review. Its family tree reaches back 3 generations to 1995. 2 later devices descend from it.
- Decided
- May 26, 2016
- Review
- 261 days
- Class
- Class II
- Product code
- OYJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K945952 (1995). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK945952 Vacutainer (R) Brand Plus PST (TM) Plasma Separation TubeBd Becton Dickinson Vacutainer Systems Preanalytic · 1995 · Recalled
- 2 generations backK972075 Vacutainer Brand PPT Plasma Preparation TubeBecton Dickinson Vacutainer Systems · 1998
- 1 generation backK110701 Oragene-DX Ogd-500; Oragene-DX Ogd-575; Oragene-DX Oxd-525…DNA Genotek, Inc. · 2011
- This deviceK152556 Oragene DxDNA Genotek, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK192920 Oragene®•DxDNA Genotek, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK212745 ORAcollect®•DxDNA Genotek, Inc. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945952 | Vacutainer (R) Brand Plus PST (TM) Plasma Separation Tube | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995 | 10 |
| −2 | K972075 | Vacutainer Brand PPT Plasma Preparation Tube | Becton Dickinson Vacutainer Systems | 1998 | — |
| −1 | K110701 | Oragene-DX Ogd-500; Oragene-DX Ogd-575; Oragene-DX Oxd-525; Oragene-DX Oyd-500 | DNA Genotek, Inc. | 2011 | — |
| 0 (this device) | K152556 | Oragene Dx | DNA Genotek, Inc. | 2016 | — |
| +1 | K192920 | Oragene®•Dx | DNA Genotek, Inc. | 2020 | — |
| +2 | K212745 | ORAcollect®•Dx | DNA Genotek, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OYJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OYJ device
- #1 K212745 ORAcollect®•Dxscore 5.4 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K110701 | Oragene-DX Ogd-500; Oragene-DX Ogd-575; Oragene-DX Oxd-525; Oragene-DX Oyd-500Summary page 4…Classification: Class II Product Code: OYJ DNA Specimen Collection, Saliva Predicate Device Oragene·Dx OGD-500 (k110701) Regulatory Classification Regulation: 21CFR 862.1675 Blood specimen collection device Panel: Chemi… | 2011 |
| † | K110786 | Esensor Warfarin Sensitivity Saliva Test | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192920 | Oragene®•Dx | 2020 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K192920 (DNA Genotek, Inc., 2020) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K110701.
How does its category compare?
All OYJ devicesOYJ Dna Specimen Collection, Saliva: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OYJ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · OYJ
Too few OYJ 510(k)s in any year since 2007 to give a median.
Recalls per year · OYJ
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OYJ
4in 2022
MAUDE reports naming product code OYJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 1 | 4 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Oragene-Dx devices are intended for use in the non-invasive collection of saliva samples. Human DNA from the saliva sample is isolated, stabilized, and suitable for use in FDA cleared molecular diagnostic applications. Saliva may be collected by spitting directly into the Oragene-Dx container or may be transferred into the Oragene:Dx container using a sponge. Saliva samples collected using Oragene'Dx are stabilized and can be transported and/or stored long term at ambient conditions.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152556: Oragene Dx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152556
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026