# OCC: Respiratory Virus Panel Nucleic Acid Assay System

- Device class: 2; regulation: 21 CFR 866.3980; FDA's rule: 510(k) required
- FDA decisions: 81
- 510(k) review time 2021–2025: median 29 days (middle half 25–29)
- Recalls: 4 (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: 7
- 2017: 10
- 2018: 4
- 2019: 5
- 2020: 2
- 2021: 1
- 2022: 1
- 2023: 2
- 2024: 1
- 2026: 3

## Most-cited predicates
- DEN070013: ID-Tag Respiratory Viral Panel (2008), cited by 12
- K081483: Xtag Respiratory Viral Panel (2008), cited by 11
- K073029: Proflu+ Assay (2008), cited by 10
- K092500: Modification to Proflu+ Assay (2009), cited by 10
- K091667: Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112, I019E0113, S019-0116 (2009), cited by 9
- K081030: Modification to Proflu+ Assay (2008), cited by 8
- K103175: Filmarray Respiratory Panel (RP) (2011), cited by 5
- K120267: Filmarray RP Panel (2012), cited by 4
- K123620: Filmarray Respiratory Panel (RP) (2013), cited by 4
- K151226: Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) (2015), cited by 4

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