# K093129: Illumina Verncode Genotyping Test for Facor V and Factor II

- Pathway: 510(k) (Traditional)
- Applicant: Illumina, Inc.
- Decided: Apr 28, 2010 after 208 days
- Product code: NPQ (Test, Factor V Leiden 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 K060564 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060564: Infiniti System, AutoGenomics, Inc. (2007) Summary page 2.

## Indications for use
The VeraCode Genotyping Test for Factor V and Factor II is an in vitro diagnostic device for the detection and genotyping of Factor V Leiden G1691A and Factor II (Prothrombin) G20210A point mutations in DNA obtained from EDTA-anticoagulated human blood samples. The test is intended for use on the BeadXpress System. The VeraCode Genotyping Test for Factor V and Factor II on the BeadXpress System is indicated for use as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.

Source page: https://510kreport.com/device/K093129
Methodology: https://510kreport.com/methodology