510(k) · Cleared
ClearedTruDiagnosis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Akonni Biosystems, Inc. · ODW Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
Cleared on May 24, 2019 as substantially equivalent to K073720 (Osmetech Molecular Diagnostics, 2008) after a 156-day review. Its family tree reaches back 1 generation to 2008.
- Decided
- May 24, 2019
- Review
- 156 days
- Class
- Class II
- Product code
- ODW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K073720 (2008). No later device cites it as a predicate yet.
- Root · 1 generation backK073720 Esensor Warfarin Sensitivity and XT-8 InstrumentOsmetech Molecular Diagnostics · 2008
- This deviceK183530 TruDiagnosis SystemAkonni Biosystems, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K073720 | Esensor Warfarin Sensitivity and XT-8 Instrument | Osmetech Molecular Diagnostics | 2008 | — |
| 0 (this device) | K183530 | TruDiagnosis System | Akonni Biosystems, Inc. | 2019 | — |
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 |
|---|---|---|---|
| * | K073720 | Esensor Warfarin Sensitivity and XT-8 InstrumentSummary page 4…e eSensor Warfarin Sensitivity Test and XT-8 Instrument 510(k) Submitter / Holder Osmetech Molecular Diagnostics 510(k) Number K073720 Regulation Number 21CFR §862.3360 – Drug Metabolism Enzyme Genotyping Test Tradit… | 2008 |
| † | K110786 | Esensor Warfarin Sensitivity Saliva Test | 2011 |
| † | K110701 | Oragene-DX Ogd-500; Oragene-DX Ogd-575; Oragene-DX Oxd-525; Oragene-DX Oyd-500 | 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?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate K073720.
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. 2019, 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 TruDiagnosis® System is an in vitro diagnostic device intended for processing and genotyping multiple genetic variants in a DNA sample utilizing on-slide PCR gel-drop microarray technology. The TruDiagnosis® System consists of the TruDx® 2000 Imager, the TruArray® Warfarin Sensitivity Test Kit, and the ProFlex™ PCR System using the ProFlex™ 2x Flat Sample Block. The TruDx® 2000 Imager is an instrument intended for processing and genotyping multiple…
Read the full statement (169 words)
The TruDiagnosis® System is an in vitro diagnostic device intended for processing and genotyping multiple genetic variants in a DNA sample utilizing on-slide PCR gel-drop microarray technology. The TruDiagnosis® System consists of the TruDx® 2000 Imager, the TruArray® Warfarin Sensitivity Test Kit, and the ProFlex™ PCR System using the ProFlex™ 2x Flat Sample Block.
The TruDx® 2000 Imager is an instrument intended for processing and genotyping multiple genetic variants in a DNA sample utilizing on-slide PCR gel-drop microarray technology.
The TruArray® Warfarin Sensitivity Test Kit is an in vitro diagnostic test for the detection and genotyping of the 2C9*2, 2C9*3 alleles of the cytochrome P450 (CYP450) 2C9 gene locus and Vitamin K epoxide reductase Cl, VKORCl, gene promoter polymorphism (-1639) from genomic DNA of human saliva samples collected using the Oragene® Dx Device (OGD-500) as an aid in the identification of patients at risk for increased warfarin sensitivity. The TruArray® Warfarin Sensitivity Test Kit is a qualitative assay for use in clinical laboratories upon prescription by the attending physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183530 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183530: TruDiagnosis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183530
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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