De Novo · Granted
GrantedFactor V Leiden Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · NPQ Test, Factor V Leiden Mutations, Genomic Dna Pcr
Granted on Dec 17, 2003 as a new device type through De Novo after a 9-day review. 10 later devices descend from it.
- Decided
- Dec 17, 2003
- Review
- 9 days
- Class
- Class II
- Product code
- NPQ
- Recalls
- None
10 later devices descend from it, 5 citing it directly.
- This deviceDEN030005 Factor V Leiden KitRoche Diagnostics Corp. · 2003
- Descendant · cites it directly · 3 of its ownK070597 Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and…Nanosphere, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK082118 Xpert Hemosil Factor II & Factor V AssayCepheid · 2009
- Descendant · 2 generations on · 1 of its ownK223046 Xpert® FII & FVCepheid® · 2023
- Descendant · 3 generations on · 0 of its ownK250218 Xpert® FII & FVCepheid · 2025
- Descendant · cites it directly · 0 of its ownK172913 cobas Factor II and Factor V TestRoche Molecular Systems, Inc. · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K070597Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and Mthfr Nucleic Acid TestNanosphere, Inc. · 2007 · cites it directly3descendants
- K082118Xpert Hemosil Factor II & Factor V AssayCepheid · 2009 · cites it directly2descendants
- K223046Xpert® FII & FVCepheid® · 2023 · 2 generations on1descendant
- K250218Xpert® FII & FVCepheid · 2025 · 3 generations on0descendants
- K172913cobas Factor II and Factor V TestRoche Molecular Systems, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN030005 | Factor V Leiden Kit | Roche Diagnostics Corp. | 2003 | — |
| +1 | K070597 | Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and Mthfr Nucleic… | Nanosphere, Inc. | 2007 | — |
| +1 | K082118 | Xpert Hemosil Factor II & Factor V Assay | Cepheid | 2009 | — |
| +2 | K223046 | Xpert® FII & FV | Cepheid® | 2023 | — |
| +3 | K250218 | Xpert® FII & FV | Cepheid | 2025 | — |
| +1 | K172913 | cobas Factor II and Factor V Test | Roche Molecular Systems, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NPQ? 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (10)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070597 | Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and Mthfr Nucleic Acid Test | 2007 | 3 |
| K082118 | Xpert Hemosil Factor II & Factor V Assay | 2009 | 2 |
| K172913 | cobas Factor II and Factor V Test | 2018 | 0 |
| K132978 | Impact DX Factor V Leiden and Factor II Genotyping Test | 2014 | 0 |
| K100980 | Invader Factor V | 2011 | 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, K070597 (Nanosphere, Inc., 2007) has gone furthest, with 3 descendants of its own.
How does its category compare?
All NPQ devicesNPQ Test, Factor V Leiden Mutations, Genomic Dna Pcr: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NPQ
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · NPQ
Too few NPQ 510(k)s in any year since 2007 to give a median.
Recalls per year · NPQ
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NPQ
2in 2017
MAUDE reports naming product code NPQ, 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 | 1 | — | 1 | 0 |
| 2008 | 0 | — | 2 | 0 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 2 | — | 1 | 2 |
| 2011 | 1 | — | 1 | 15 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 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 | — |
https://510kreport.com/device/DEN030005 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN030005: Factor V Leiden Kit.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN030005
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026