510(k) · Cleared
ClearedXpert Hemosil Factor II & Factor V Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cepheid · NPQ Test, Factor V Leiden Mutations, Genomic Dna Pcr
Cleared on Sep 18, 2009 as substantially equivalent to K033612 (Roche Diagnostics Corp., 2003) and 1 other predicate after a 417-day review. Its family tree reaches back 1 generation to 2003. 2 later devices descend from it.
- Decided
- Sep 18, 2009
- Review
- 417 days
- Class
- Class II
- Product code
- NPQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to DEN030005 (2003). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backDEN030005 Factor V Leiden KitRoche Diagnostics Corp. · 2003
- This deviceK082118 Xpert Hemosil Factor II & Factor V AssayCepheid · 2009
- Descendant · cites it directly · 1 of its ownK223046 Xpert® FII & FVCepheid® · 2023
- Descendant · 2 generations on · 0 of its ownK250218 Xpert® FII & FVCepheid · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN030005 | Factor V Leiden Kit | Roche Diagnostics Corp. | 2003 | — |
| 0 (this device) | K082118 | Xpert Hemosil Factor II & Factor V Assay | Cepheid | 2009 | — |
| +1 | K223046 | Xpert® FII & FV | Cepheid® | 2023 | — |
| +2 | K250218 | Xpert® FII & FV | Cepheid | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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 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
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K033612 | Factor II (Prothrombin) G20210A KitSummary page 1…Hematology Advisory Committee: Predicate Devices: Roche Factor 1I (Prothrombin) G2021I OA Kit (5 10(k) #k033612) and Roche Factor V Leiden Kit (5 10(k) #k033 607) Device Description: The Cepheid Xpert® Hem… | 2003 |
| * | DEN030005 | Factor V Leiden Kit Our reading of the summary gave K033607, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN030005, Factor V Leiden Kit (Roche Diagnostics Corp.), granted Dec 17, 2003; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223046 | Xpert® FII & FV | 2023 | 1 |
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?
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. 2009, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Xpert TM HemosIL® Factor II & Factor V Assay is a qualitative in vitro diagnostic genotyping test for the rapid detection of Factor II and Factor V alleles from sodium citrate or EDTA anticoagulated whole blood. The test is performed on the Cepheid GeneXpert® Dx System. This test is intended to provide rapid results for Factor II (G20210A) and Factor V (Leiden) mutations as an aid in the diagnosis in individuals with suspected thrombophilia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082118 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082118: Xpert Hemosil Factor II & Factor V Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082118
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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