# OOU: Parainfluenza Multiplex Nucleic Acid Assay

- Device class: 2; regulation: 21 CFR 866.3980; FDA's rule: 510(k) required
- FDA decisions: 5
- 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)
- 2009: 1
- 2013: 1
- 2014: 1
- 2015: 1
- 2017: 1

## Most-cited predicates
- K091053: Proparaflu+Assay (2009), cited by 3
- K153223: ProParaFlu+ Assay (2015), cited by 1
- K132238: Proparaflu+ Assay (2013), cited by 1

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