# K172913: cobas Factor II and Factor V Test

- Pathway: 510(k) (Traditional)
- Applicant: Roche Molecular Systems, Inc.
- Decided: Jan 12, 2018 after 109 days
- Product code: NPR (Test, Factor Ii G20210a Mutations, Genomic Dna Pcr)
- 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: 1 generation back to DEN030005 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033612: Factor II (Prothrombin) G20210A Kit, Roche Diagnostics Corp. (2003) Summary page 5.
- 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K172913
Methodology: https://510kreport.com/methodology