510(k) · Cleared
ClearedORAcollect®•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 Oct 27, 2022 as substantially equivalent to K192920 (DNA Genotek, Inc., 2020) after a 423-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Oct 27, 2022
- Review
- 423 days
- Class
- Class II
- Product code
- OYJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K945952 (1995). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK945952 Vacutainer (R) Brand Plus PST (TM) Plasma Separation TubeBd Becton Dickinson Vacutainer Systems Preanalytic · 1995 · Recalled
- 4 generations backK972075 Vacutainer Brand PPT Plasma Preparation TubeBecton Dickinson Vacutainer Systems · 1998
- 3 generations backK110701 Oragene-DX Ogd-500; Oragene-DX Ogd-575; Oragene-DX Oxd-525…DNA Genotek, Inc. · 2011
- 2 generations backK141410 Oragene DX Ogd-500.001DNA Genotek, Inc. · 2015
- 1 generation backK192920 Oragene®•DxDNA Genotek, Inc. · 2020
- This deviceK212745 ORAcollect®•DxDNA Genotek, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945952 | Vacutainer (R) Brand Plus PST (TM) Plasma Separation Tube | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995 | 10 |
| −4 | K972075 | Vacutainer Brand PPT Plasma Preparation Tube | Becton Dickinson Vacutainer Systems | 1998 | — |
| −3 | K110701 | Oragene-DX Ogd-500; Oragene-DX Ogd-575; Oragene-DX Oxd-525; Oragene-DX Oyd-500 | DNA Genotek, Inc. | 2011 | — |
| −2 | K141410 | Oragene DX Ogd-500.001 | DNA Genotek, Inc. | 2015 | — |
| −1 | K192920 | Oragene®•Dx | DNA Genotek, Inc. | 2020 | — |
| 0 (this device) | K212745 | ORAcollect®•Dx | DNA Genotek, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2016 | 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 K192920 Oragene®•Dxscore 2.6 · 4 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K192920 | Oragene®•DxSummary page 4…Classification: Class II Product Code: OYJ DNA Specimen Collection, Saliva Predicate Device Oragene®•Dx (k192920) Regulation: 21CFR 862.1675 Blood specimen collection device Panel: Chemi… | 2020 |
| † | K152464 | ORAcollect.Dx | 2016 |
| † | K110701 | Oragene-DX Ogd-500; Oragene-DX Ogd-575; Oragene-DX Oxd-525; Oragene-DX Oyd-500 | 2011 |
| † | K141410 | Oragene DX Ogd-500.001 | 2015 |
| † | K152556 | Oragene Dx | 2016 |
| † | K152612 | eSensor Warfarin Sensitivity Saliva Test | 2016 |
| † | K192858 | A1AT Genotyping Test | 2019 |
| † | K211115 | A1AT Genotyping Test | 2021 |
| † | K221420 | AlphaID™ At Home Genetic Health Risk Service | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 7 ancestors has a recall of any class.
How does its category compare?
All OYJ devicesOYJ Dna Specimen Collection, Saliva: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
ORACcollect®+Dx is intended for the collection of saliva samples for diagnostic testing of human DNA. Saliva samples may be collected by a healthcare professional or non-healthcare professional, such as a lay user. Saliva samples collected using ORAcollect®+Dx are stabilized and isolated for use in downstream diagnostic testing applications. Saliva samples collected using ORAcollect®+Dx can be transported and/or stored 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/K212745 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212745: ORAcollect®•Dx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212745
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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