# PSZ: Devices Detecting Influenza A, B, And C Virus Antigens

- Device class: 2; regulation: 21 CFR 866.3328; FDA's rule: 510(k) required
- FDA decisions: 73
- 510(k) review time 2021–2025: median 131 days (middle half 119–194)
- Recalls: 2 (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)
- 2013: 8
- 2014: 1
- 2015: 4
- 2016: 3
- 2017: 3
- 2018: 5
- 2020: 2
- 2023: 2
- 2025: 2
- 2026: 2

## Most-cited predicates
- K112277: BD Veritor (TM) System for Rapid Detection of Flu a+B (2011), cited by 8
- K132259: BD Veritor System for the Rapid Detection of Flu a+B (2013), cited by 7
- K132692: BD Veritor System for the Rapid Detection of Flu a+B (2013), cited by 7
- K053146: Quickvue Influenza a + B Test (2005), cited by 6
- K121797: BD Veritor (TM) System for Rapid Detection of Flu a+B (2012), cited by 6
- K120049: BD Veritor System for the Rapid Detection of Flu a+B (2012), cited by 6
- K132256: BD Veritor System for the Rapid Detection of Flu a+B (2013), cited by 5
- K021649: Binax Now Flu a Test (27 Test), Binax Now Nasopharyngeal Swab Specimen Accesory Pack (2002), cited by 5
- K031899: Quickvue Influenza a+B Test (2003), cited by 4
- K991633: Quickvue Influenza a/B Test (1999), cited by 4

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