510(k) · Cleared
Recalled · 2010Factor II (Prothrombin) G20210A Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · NPR Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
Cleared on Dec 18, 2003 after a 31-day review. The FDA summary names no predicate by number. 10 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 18, 2003
- Review
- 31 days
- Class
- Class II
- Product code
- NPR
- Recalls
- 2
- Predicates
- 0
10 later devices descend from it, 5 citing it directly.
- This deviceK033612 Factor II (Prothrombin) G20210A 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) | K033612 | Factor II (Prothrombin) G20210A 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 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?
The FDA summary names no predicate by number.
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 |
| K100943 | Invader Factor II | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 26, 2010 | Not classified | Z-1652-2011 | Software design | If the bar code is printed from the Batch Results Screen, a wrong batch ID may be printed, while the correct batch ID is still assigned to the batch in the data repository of the MPLC 2.0 software. This may result in sample mis… |
| Mar 12, 2009 | Not classified | Z1006-2010 | Labeling design | Within the Precautions and Warning Section, Polymorphism heading, of the Product's Package Insert, it stated that mutations at positions 20207, 20209, 20218 and 20221 exist and these mutations are spanned by the mutation probe. These rare… |
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 NPR devicesNPR Test, Factor Ii G20210a Mutations, Genomic Dna Pcr: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Factor II (Prothrombin) G20210A Kit is an in vitro diagnostic test for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene, from DNA isolated from human whole peripheral blood.
The Factor II (Prothrombin) G20210A Kit is indicated as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
The test is intended to be used on the LightCycler Instrument. The sample preparation must be performed according to a workflow procedure described in the package insert.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033612: Factor II (Prothrombin) G20210A Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033612
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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