# K100496: Invader Mthfr 1298

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Apr 25, 2011 after 427 days
- Product code: OMM (Test 5, 10-Methylenetetrahydrofolate Reductase 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: 5 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)
- K070597: Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and Mthfr Nucleic Acid Test, Nanosphere, Inc. (2007) Summary page 2.

## Indications for use
The Invader® MTHFR 1298 test is an in vitro diagnostic test intended for the detection and genotyping of a single point mutation (A to C at position 1298) of the human 5,10-methylenetetrahydrofolate reductase (MTHFR) gene in isolated genomic DNA obtained from whole blood potassium EDTA samples from patients with suspected thrombophilia.

Source page: https://510kreport.com/device/K100496
Methodology: https://510kreport.com/methodology