# K070597: Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and Mthfr Nucleic Acid Test

- Pathway: 510(k) (Traditional)
- Applicant: Nanosphere, Inc.
- Decided: Oct 11, 2007 after 223 days
- Product code: NSU (Instrumentation For Clinical Multiplex Test Systems)
- Device class: 2
- Regulation: 21 CFR 862.2570
- 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). 8 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033734: Lightcycler Instrument Version 1.2, Roche Diagnostics Corp. (2003) Summary page 2.
- 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 2.

## Most influential descendants
- K100987: Invader Mthfr 677 (2011), 0 descendants of its own
- K100496: Invader Mthfr 1298 (2011), 0 descendants of its own
- K093974: Esenor Fii-FV-Mthfr Genotyping Test, Esenor Fii-FV Genotyping Test, Esenor Fii Genotyping (2010), 0 descendants of its own

## Indications for use
The Verigene System is a bench-top molecular diagnostics workstation that automates the analysis and detection of nucleic acids using gold nanoparticle probe technology. The Verigene F5 Nucleic Acid Test is indicated as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. The test is an in vitro diagnostic for the detection and genotyping of a single-point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene), from isolated genomic DNA obtained from whole blood samples. The test is intended to be used on the Verigene System. The Verigene F2 Nucleic Acid Test is indicated as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. The test is an in vitro diagnostic for the detection and genotyping of a single-point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene), from isolated genomic DNA obtained from whole blood samples. The test is intended to be used on the Verigene System. The Verigene MTHFR Nucleic Acid Test is indicated as an aid to diagnosis in the evaluation of patients with suspected thrombophilia and elevated levels of homocysteine or altered folate metabolism. The test is an in vitro diagnostic for the detection and genotyping of a single-point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR), from isolated genomic DNA obtained from whole blood samples. The test is intended to be used on the Verigene System.

Source page: https://510kreport.com/device/K070597
Methodology: https://510kreport.com/methodology