# K100943: Invader Factor II

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Jun 2, 2011 after 422 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 K033612 (2003). 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)
- K033612: Factor II (Prothrombin) G20210A Kit, Roche Diagnostics Corp. (2003) Summary page 2.

## Indications for use
The Invader® Factor II test is an in vitro diagnostic test intended for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene in isolated genomic DNA obtained from whole blood potassium EDTA samples from patients with suspected thrombophilia.

Source page: https://510kreport.com/device/K100943
Methodology: https://510kreport.com/methodology