510(k) · Cleared
ClearedXpert® FII & FV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cepheid · NPR Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
Cleared on Feb 21, 2025 as substantially equivalent to K223046 (Cepheid®, 2023) after a 28-day review. Its family tree reaches back 3 generations to 2003.
- Decided
- Feb 21, 2025
- Review
- 28 days
- Class
- Class II
- Product code
- NPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN030005 (2003). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN030005 | Factor V Leiden Kit | Roche Diagnostics Corp. | 2003 | — |
| −2 | K082118 | Xpert Hemosil Factor II & Factor V Assay | Cepheid | 2009 | — |
| −1 | K223046 | Xpert® FII & FV | Cepheid® | 2023 | — |
| 0 (this device) | K250218 | Xpert® FII & FV | Cepheid | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 NPR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NPR device
- #1 K223046 Xpert® FII & FVscore 8.1 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K223046 | Xpert® FII & FVSummary page 5…, NPQ, OOI Classification: Class II Review Panel: Pathology Prescription Use: Yes Predicate Device: Xpert FII & FV (K223046) 1. Device Description Xpert FII & FV is an automated genotyping test for detecting Factor II and Factor V normal and mutant a… | 2023 |
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 22 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All NPR devicesNPR Test, Factor Ii G20210a Mutations, Genomic Dna Pcr: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · NPR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NPR
Too few NPR 510(k)s in any year since 2007 to give a median.
Recalls per year · NPR
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NPR
1in 2019
MAUDE reports naming product code NPR, 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 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 1 | — | 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 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Xpert® FII & FV test is a qualitative in vitro diagnostic genotyping test for the detection of Factor II and Factor V alleles from sodium citrate or EDTA anticoagulated whole blood. The test is performed on the GeneXpert® Instrument Systems. This test is intended to provide results for Factor II (G20210A) and Factor V Leiden (G1691A) 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/K250218 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250218: Xpert® FII & FV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250218
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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