510(k) · Cleared
Clearedcobas Factor II and Factor V Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Molecular Systems, Inc. · NPR Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
Cleared on Jan 12, 2018 as substantially equivalent to K033612 (Roche Diagnostics Corp., 2003) and 1 other predicate after a 109-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Jan 12, 2018
- Review
- 109 days
- Class
- Class II
- Product code
- NPR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to DEN030005 (2003). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backDEN030005 Factor V Leiden KitRoche Diagnostics Corp. · 2003
- This deviceK172913 cobas Factor II and Factor V TestRoche Molecular Systems, Inc. · 2018
View 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) | K172913 | cobas Factor II and Factor V Test | Roche Molecular Systems, Inc. | 2018 | — |
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 K250218 Xpert® FII & FVscore 9.5 · 3 generations · no Class I recall
- #2 Held for the reportin 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 5…N/A Classification Name Factor V Leiden DNA mutation detection system Product Codes NPR,NPQ 21 CFR 864.7280 Predicate Devices K033612 & K033607 Establishment Registration 2243471 & 3004141078… | 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?
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?
- 1 of the 2 ancestors has a recall of any class.
- 4 other devices also cite its predicate K033612.
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. 2018, 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 cobas® Factor II and Factor V Test is an in vitro diagnostic device that uses real-time PCR for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation and the Factor V Leiden G1691A mutation in genomic DNA obtained from K2EDTA whole blood specimens as an aid in diagnosis of patients with suspected thrombophilia.
The cobas® Factor II and Factor V Test and the cobas z 480 analyzer are used together for automated amplification and detection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172913 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172913: cobas Factor II and Factor V Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172913
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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