510(k) · Cleared
ClearedEQ-PRC LC Warfarin Genotyping Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trimgen Corporation · ODW Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
Cleared on Feb 6, 2009 as substantially equivalent to K070804 (Nanosphere, Inc., 2007) after a 464-day review. Its family tree reaches back 4 generations to 2004.
- Decided
- Feb 6, 2009
- Review
- 464 days
- Class
- Class II
- Product code
- ODW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN040011 (2004). No later device cites it as a predicate yet.
- Root · 4 generations backDEN040011 Amplichip CYP450 Test, Model 04381866190Roche Molecular Systems, Inc. · 2004
- 3 generations backK043576 Roche Amplichip CYP450 TestRoche Molecular Systems, Inc. · 2005 · Recalled
- 2 generations backK051824 Invader UGT1A1 Molecular AssayThird Wave Technologies, Inc. · 2005
- 1 generation backK070804 Verigene System, Verigene Warfarin Metabolism Nucleic Acid TestNanosphere, Inc. · 2007 · Recalled
- This deviceK073071 EQ-PRC LC Warfarin Genotyping KitTrimgen Corporation · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN040011 | Amplichip CYP450 Test, Model 04381866190 | Roche Molecular Systems, Inc. | 2004 | — |
| −3 | K043576 | Roche Amplichip CYP450 Test | Roche Molecular Systems, Inc. | 2005 | 1 |
| −2 | K051824 | Invader UGT1A1 Molecular Assay | Third Wave Technologies, Inc. | 2005 | — |
| −1 | K070804 | Verigene System, Verigene Warfarin Metabolism Nucleic Acid Test | Nanosphere, Inc. | 2007 | 1 |
| 0 (this device) | K073071 | EQ-PRC LC Warfarin Genotyping Kit | Trimgen Corporation | 2009 | — |
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 |
|---|---|---|---|
| * | K070804 | Verigene System, Verigene Warfarin Metabolism Nucleic Acid TestSummary page 1…mber: 21 CFR 862.3360 Classification Name: Drug metabolizing enzyme genotyping system PREDICATE DEVICE Verigene® Warfarin Metabolism Nucleic Acid Test (K070804) INTENDED USE The eQ-PCRTM LC Warfarin Genotyping kit is an in vitro diagnostic test for the detection and genotyping… | 2007 |
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 5 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 4 ancestors have a recall of any class.
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. 2009, 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 eQ-PCRTM LC Warfarin Genotyping kit is an in vitro diagnostic test for the detection and genotyping of two single nucleotide polymorphisms (SNP) in the cytochrome P450 enzyme gene CYP2C9 known as CYP2C9*2 (C430T) and CYP2C9*3 (Al 075C), and a SNP in the vitamin K epoxide reductase complex 1 gene VKORC1, known as VKORC1 (-1 639G>A) obtained from EDTA - anticoagulated whole blood samples. The eQ-PCR LC Warfarin Genotyping kit is used as an aid in the identification of patients at risk for increased warfarin sensitivity. It 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/K073071 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073071: EQ-PRC LC Warfarin Genotyping Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073071
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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