510(k) · Cleared
ClearedeSensor Warfarin Sensitivity Saliva Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genmark Diagnostics, Incorporated · ODW Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
Cleared on May 26, 2016 as substantially equivalent to K110786 (GenMark Diagnostics, Inc., 2011) after a 255-day review. Its family tree reaches back 2 generations to 2008.
- Decided
- May 26, 2016
- Review
- 255 days
- Class
- Class II
- Product code
- ODW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K073720 (2008). No later device cites it as a predicate yet.
- Root · 2 generations backK073720 Esensor Warfarin Sensitivity and XT-8 InstrumentOsmetech Molecular Diagnostics · 2008
- 1 generation backK110786 Esensor Warfarin Sensitivity Saliva TestGenMark Diagnostics, Inc. · 2011
- This deviceK152612 eSensor Warfarin Sensitivity Saliva TestGenmark Diagnostics, Incorporated · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K073720 | Esensor Warfarin Sensitivity and XT-8 Instrument | Osmetech Molecular Diagnostics | 2008 | — |
| −1 | K110786 | Esensor Warfarin Sensitivity Saliva Test | GenMark Diagnostics, Inc. | 2011 | — |
| 0 (this device) | K152612 | eSensor Warfarin Sensitivity Saliva Test | Genmark Diagnostics, Incorporated | 2016 | — |
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 ODW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K110786 | Esensor Warfarin Sensitivity Saliva TestSummary page 5…2.2570 1 Predicate device: eSensor® Warfarin Sensitivity Saliva Test, K110786 This premarket application is a labeling modification to a previously cleared device: addition of a new specimen collection kit.… | 2011 |
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 8 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All ODW devicesODW Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · ODW
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · ODW
Too few ODW 510(k)s in any year since 2007 to give a median.
Recalls per year · ODW
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODW
No MAUDE report names ODW since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The eSensor® Warfarin Sensitivity Saliva Test is an in vitro diagnostic for the detection and genotyping of the *2 and *3 alleles of the cytochrome P450 (CYP450) 2C9 gene locus and the Vitamin K epoxide reductase C1 (VKORC1) gene promoter polymorphism (-1639G>A) from genomic DNA extracted from human saliva samples collected using the Oragene®•Dx and ORAcollect®•Dx devices, as an aid in the identification of patients at risk for increased warfarin sensitivity.
The eSensor® XT-8 instrument is an in vitro diagnostic device intended for genotyping multiple mutations or polymorphisms in an amplified DNA sample utilizing electrochemical detection technology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152612: eSensor Warfarin Sensitivity Saliva Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152612
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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