510(k) · Cleared
ClearedImpact DX Factor V Leiden and Factor II Genotyping Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sequenom, Inc. · PHJ System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations
Cleared on Jun 13, 2014 as substantially equivalent to DEN030005 (Roche Diagnostics Corp., 2003) and 3 other predicates after a 263-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Jun 13, 2014
- Review
- 263 days
- Class
- Class II
- Product code
- PHJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K922906 (1993). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK922906 Amplicor Chlamydia Trachomatis TestRoche Molecular Systems, Inc. · 1993
- 3 generations backK964506 Roche Cobas Amplicor AnalyzerRoche Molecular Systems, Inc. · 1997 · Recalled
- 2 generations backK012966 Roche Cobas Taqman AnalyzerRoche Molecular Systems, Inc. · 2002 · Recalled
- 1 generation backK033734 Lightcycler Instrument Version 1.2Roche Diagnostics Corp. · 2003 · Recalled
- This deviceK132978 Impact DX Factor V Leiden and Factor II Genotyping TestSequenom, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922906 | Amplicor Chlamydia Trachomatis Test | Roche Molecular Systems, Inc. | 1993 | — |
| −3 | K964506 | Roche Cobas Amplicor Analyzer | Roche Molecular Systems, Inc. | 1997 | 1 |
| −2 | K012966 | Roche Cobas Taqman Analyzer | Roche Molecular Systems, Inc. | 2002 | 3 |
| −1 | K033734 | Lightcycler Instrument Version 1.2 | Roche Diagnostics Corp. | 2003 | 1 |
| 0 (this device) | K132978 | Impact DX Factor V Leiden and Factor II Genotyping Test | Sequenom, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2003 | 2 | 0 |
| 2007 | 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 PHJ? 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? (4)
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 |
|---|---|---|---|
| * | 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 |
| * | K033612 | Factor II (Prothrombin) G20210A KitSummary page 1…te Devices ASSAY Roche Factor V Leiden Kit (K033607) Roche Factor 11 (Prothrombin) G2021I0A Kit (K0336 12) INSTRUMENT Roche LightCycler® (K033734) AutoGenomics INFINIT… | 2003 |
| * | K033734 | Lightcycler Instrument Version 1.2Summary page 1…en Kit (K033607) Roche Factor 11 (Prothrombin) G2021I0A Kit (K0336 12) INSTRUMENT Roche LightCycler® (K033734) AutoGenomics INFINITITM System (K060564) IM PA Cf Dx Factoi… | 2003 |
| * | K060564 | Infiniti SystemSummary page 1…mbin) G2021I0A Kit (K0336 12) INSTRUMENT Roche LightCycler® (K033734) AutoGenomics INFINITITM System (K060564) IM PA Cf Dx Factoi V Leiden and Faclor 11Cenoty ping Pest 510(k) SUmmiary C… | 2007 |
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 21 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 5 of the 9 ancestors have a recall of any class.
- 4 other devices also cite its predicate DEN030005.
How does its category compare?
All PHJ devicesPHJ System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PHJ
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · PHJ
Too few PHJ 510(k)s in any year since 2007 to give a median.
Recalls per year · PHJ
No recall names PHJ since 2007.
Adverse event reports per year · PHJ
No MAUDE report names PHJ since 2007.
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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 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 IMPACT Dx Factor V Leiden and Factor II Genotyping Test is a qualitative in vitro diagnostic device intended for use in the detection and genotyping of a single point mutation (G1691A, referred to as the Factor V Leiden mutation or FVL) of the Factor V gene, located on Chromosome 1q23, and a single point mutation (G20210A) of the prothrombin gene (referred to as Factor II or FII), located on Chromosome 1p11-q12, from genomic DNA isolated from EDTA anti-coagulated human whole blood samples. The test is to be performed on the IMPACT Dx System and is indicated for use as an aid in the diagnosis of patients with suspected thrombophilia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132978 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132978: Impact DX Factor V Leiden and Factor II Genotyping Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132978
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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