# K132978: Impact DX Factor V Leiden and Factor II Genotyping Test

- Pathway: 510(k) (Traditional)
- Applicant: Sequenom, Inc.
- Decided: Jun 13, 2014 after 263 days
- Product code: PHJ (System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations)
- Device class: 2
- Regulation: 21 CFR 864.7280
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K922906 (1993). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN030005: Factor V Leiden Kit, Roche Diagnostics Corp. (2003). 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.
- K033612: Factor II (Prothrombin) G20210A Kit, Roche Diagnostics Corp. (2003) Summary page 1.
- K033734: Lightcycler Instrument Version 1.2, Roche Diagnostics Corp. (2003) Summary page 1.
- K060564: Infiniti System, AutoGenomics, Inc. (2007) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K132978
Methodology: https://510kreport.com/methodology