# OZE: Influenza A And Influenza B Multiplex Nucleic Acid Assay

- Device class: 2; regulation: 21 CFR 866.3980; FDA's rule: 510(k) required
- FDA decisions: 21
- 510(k) review time 2021–2025: median 84 days (middle half 32–98)
- 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)
- 2016: 1
- 2017: 1
- 2018: 2
- 2019: 3
- 2020: 1
- 2022: 1
- 2023: 1
- 2024: 1
- 2025: 2
- 2026: 1

## Most-cited predicates
- K132508: CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (2013), cited by 4
- K172091: CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit (2017), cited by 2
- K131728: Quidel Molecular Influenza a + B Assay (2013), cited by 2
- K190302: CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit (2019), cited by 2
- K220801: ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 (2022), cited by 2
- K161556: CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (2016), cited by 1
- K140857: Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (2014), cited by 1
- K113777: Quidel Molecular Influenza a+B (2012), cited by 1
- K200370: CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit (2020), cited by 1
- K190204: ID NOW Influenza A & B 2 (2019), cited by 1

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