510(k) · Cleared
Recalled · 2008Verigene System, Verigene Warfarin Metabolism Nucleic Acid Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanosphere, Inc. · ODW Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
Cleared on Sep 17, 2007 as substantially equivalent to K051824 (Third Wave Technologies, Inc., 2005) after a 178-day review. Its family tree reaches back 3 generations to 2004. 1 later device descends from it. It has been recalled once.
- Decided
- Sep 17, 2007
- Review
- 178 days
- Class
- Class II
- Product code
- ODW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN040011 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backDEN040011 Amplichip CYP450 Test, Model 04381866190Roche Molecular Systems, Inc. · 2004
- 2 generations backK043576 Roche Amplichip CYP450 TestRoche Molecular Systems, Inc. · 2005 · Recalled
- 1 generation backK051824 Invader UGT1A1 Molecular AssayThird Wave Technologies, Inc. · 2005
- This deviceK070804 Verigene System, Verigene Warfarin Metabolism Nucleic Acid TestNanosphere, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK073071 EQ-PRC LC Warfarin Genotyping KitTrimgen Corporation · 2009
Most influential descendants
Showing 1 of 1 · See all- K073071EQ-PRC LC Warfarin Genotyping KitTrimgen Corporation · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN040011 | Amplichip CYP450 Test, Model 04381866190 | Roche Molecular Systems, Inc. | 2004 | — |
| −2 | K043576 | Roche Amplichip CYP450 Test | Roche Molecular Systems, Inc. | 2005 | 1 |
| −1 | K051824 | Invader UGT1A1 Molecular Assay | Third Wave Technologies, Inc. | 2005 | — |
| 0 (this device) | K070804 | Verigene System, Verigene Warfarin Metabolism Nucleic Acid Test | Nanosphere, Inc. | 2007 | — |
| +1 | K073071 | EQ-PRC LC Warfarin Genotyping Kit | Trimgen Corporation | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 |
|---|---|---|---|
| * | K051824 | Invader UGT1A1 Molecular AssaySummary page 2…onents. 1 of 5 Predicate device Third Wave Technologies, Inc., Invader® UGT1A1 Molecular Assay (k051824) Device The Verigene System is an in vitro diagnostic device for processing and genotyping multiple descriptions… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073071 | EQ-PRC LC Warfarin Genotyping Kit | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 25, 2008 | Not classified | Z-1383-2008 | Other | Aberrant Results: A warfarin 2C9*2 mutant capture signal was found to be high enough to result in an aberrant result (i.e., wild-type called heterozygous). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 7 months on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K073071 (Trimgen Corporation, 2009) has gone furthest, with 0 descendants 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. 2007, 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 Verigene System is an in vitro diagnostic device intended for processing and genotyping multiple genes in a DNA sample utilizing gold nanoparticle probe technology. The Verigene System consists of the Verigene Processor and the Verigene Reader, each with its own onboard proprietary software. The Verigene Warfarin Metabolism Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of the *2 and *3 alleles of the CYP2C9 gene and a…
Read the full statement (115 words)
The Verigene System is an in vitro diagnostic device intended for processing and genotyping multiple genes in a DNA sample utilizing gold nanoparticle probe technology. The Verigene System consists of the Verigene Processor and the Verigene Reader, each with its own onboard proprietary software.
The Verigene Warfarin Metabolism Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of the *2 and *3 alleles of the CYP2C9 gene and a single-point polymorphism (C to T at position 1173) of the VKORCI gene, from EDTA-anticoagulated whole blood samples, as an aid in the identification of patients at risk for increased warfarin sensitivity. The test is intended to be used on the Verigene System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070804 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070804: Verigene System, Verigene Warfarin Metabolism Nucleic Acid Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070804
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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