# SCA: Multi-Analyte Respiratory Virus Antigen Detection Test

- Device class: 2; regulation: 21 CFR 866.3987; FDA's rule: 510(k) required
- FDA decisions: 13
- 510(k) review time 2021–2025: median 116 days (middle half 90–203)
- 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)
- 2024: 1
- 2025: 10
- 2026: 2

## Most-cited predicates
- DEN240029: Healgen Rapid Check COVID-19/Flu A&B Antigen Test (2024), cited by 4
- K243256: WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest (2025), cited by 4

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