510(k) · Cleared
ClearedRapid Genotyping Assay -CYP2C9 & VKORC1, Model Catalog NO. 006+0203 Gactga
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paragondx, LLC · ODV Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System
Cleared on Apr 28, 2008 after a 297-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 28, 2008
- Review
- 297 days
- Class
- Class II
- Product code
- ODV
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ODV? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All ODV devicesODV Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) 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 · ODV
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · ODV
Too few ODV 510(k)s in any year since 2007 to give a median.
Recalls per year · ODV
No recall names ODV since 2007.
Adverse event reports per year · ODV
3in 2021
MAUDE reports naming product code ODV, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 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 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 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 Rapid Genotyping Assay - CYP2C9 & VKORCI is intended to be used as an in vitro diagnostic test kit that detects the presence of CYP2C9 *2 and *3 and VKORC1 1173 C>T alleles. This test is for use with EDTA-anticoagulated whole blood samples. Information about the CYP2C9 and VKORC1 genotypes may be used as an aid in the identification of patients with greater risk for warfarin sensitivity.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K071867 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071867: Rapid Genotyping Assay -CYP2C9 & VKORC1, Model Catalog NO. 006+0203 Gactga.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071867
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026