510(k) · Cleared
ClearedEsensor Warfarin Sensitivity and XT-8 Instrument
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osmetech Molecular Diagnostics · ODW Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
Cleared on Jul 17, 2008 after a 199-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Jul 17, 2008
- Review
- 199 days
- Class
- Class II
- Product code
- ODW
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 5 citing it directly.
- This deviceK073720 Esensor Warfarin Sensitivity and XT-8 InstrumentOsmetech Molecular Diagnostics · 2008
- Descendant · cites it directly · 1 of its ownK110786 Esensor Warfarin Sensitivity Saliva TestGenMark Diagnostics, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK090901 Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis…Osmetech Molecular Diagnostics · 2009 · Recalled
- Descendant · cites it directly · 0 of its ownK183530 TruDiagnosis SystemAkonni Biosystems, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK152612 eSensor Warfarin Sensitivity Saliva TestGenmark Diagnostics, Incorporated · 2016
- Descendant · cites it directly · 0 of its ownK113731 Esensor Respiratory Viral PanelClinical Micro Sensors, Inc. · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K110786Esensor Warfarin Sensitivity Saliva TestGenMark Diagnostics, Inc. · 2011 · cites it directly1descendant
- K090901Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping Test…Osmetech Molecular Diagnostics · 2009 · cites it directly1descendant
- K183530TruDiagnosis SystemAkonni Biosystems, Inc. · 2019 · cites it directly0descendants
- K152612eSensor Warfarin Sensitivity Saliva TestGenmark Diagnostics, Incorporated · 2016 · 2 generations on0descendants
- K113731Esensor Respiratory Viral PanelClinical Micro Sensors, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K073720 | Esensor Warfarin Sensitivity and XT-8 Instrument | Osmetech Molecular Diagnostics | 2008 | — |
| +1 | K110786 | Esensor Warfarin Sensitivity Saliva Test | GenMark Diagnostics, Inc. | 2011 | — |
| +1 | K090901 | Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping… | Osmetech Molecular Diagnostics | 2009 | 2 |
| +1 | K183530 | TruDiagnosis System | Akonni Biosystems, Inc. | 2019 | — |
| +2 | K152612 | eSensor Warfarin Sensitivity Saliva Test | Genmark Diagnostics, Incorporated | 2016 | — |
| +1 | K113731 | Esensor Respiratory Viral Panel | Clinical Micro Sensors, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 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 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 |
|---|---|---|---|
| * | — | Nanosphere Verigene® Warfarin Metabolism Nucleic Acid Test and Verigene® System Named without a submission number |
What descends from it? (6)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110786 | Esensor Warfarin Sensitivity Saliva Test | 2011 | 1 |
| K090901 | Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping Test… | 2009 | 1 |
| K183530 | TruDiagnosis System | 2019 | 0 |
| K113731 | Esensor Respiratory Viral Panel | 2012 | 0 |
| K093974 | Esenor Fii-FV-Mthfr Genotyping Test, Esenor Fii-FV Genotyping Test, Esenor Fii Genotyping | 2010 | 0 |
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?
- Of its descendants, K110786 (GenMark Diagnostics, Inc., 2011) has gone furthest, with 1 descendant of its own.
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. 2008, 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 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 C I (VKORC 1) gene promoter polymorphism Y-J6339G>A from genomic DNA extracted from whole blood samples preserved with EDTA, 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/K073720 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073720: Esensor Warfarin Sensitivity and XT-8 Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073720
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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