# OQW: 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification

- Device class: 2; regulation: 21 CFR 866.3332; FDA's rule: 510(k) required
- FDA decisions: 10
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2010: 3
- 2011: 3
- 2012: 1
- 2013: 3

## Most-cited predicates
- K101855: Profast+ Assay (2010), cited by 3
- K111507: CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (2011), cited by 2
- K100148: Simplexa Influenza a H1N1 (2009) Model MOL2500 (2010), cited by 2
- K101564: CDC Influenza 2009 a (H1N1)PDM Real-Time RT-PCR Panel (2010), cited by 2
- K103766: Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System Software Verisions 2.1 and 4.0 (2011), cited by 2
- K120911: Xpert Flu  Genexpert DX Systems (GX-I, GX-IV) (2012), cited by 1
- K130551: CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (2013), cited by 1

Source page: https://510kreport.com/product-code/OQW
Data by year (CSV): https://510kreport.com/product-code/OQW.csv