510(k) · Cleared
Recalled · Class II · 2022ORAcollect.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 269-day review. Its family tree reaches back 3 generations to 1995. It has been recalled once.
- Decided
- May 26, 2016
- Review
- 269 days
- Class
- Class II
- Product code
- OYJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K945952 (1995). 4 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK152464 ORAcollect.DxDNA Genotek, Inc. · 2016
View 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) | K152464 | ORAcollect.Dx | DNA Genotek, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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) Regulation: 21CFR 862.1675 Blood specimen collection device Panel: Chemi… | 2011 |
| † | K152612 | eSensor Warfarin Sensitivity Saliva Test | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 18, 2022 | Class II | Z-0981-2022 | Nonconforming Material/Component | Evaporation of stabilizing liquid reducing shelf life. |
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.
- 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?
ORAcollectDx is 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 samples collected using ORAcollect*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/K152464 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152464: 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/K152464
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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