# GQG: Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

- Device class: 1; regulation: 21 CFR 866.3480; FDA's rule: 510(k) exempt
- FDA decisions: 32
- 510(k) review time 2021–2025: median 180 days (middle half 180–180)
- Recalls: 3 (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)
- 2003: 3
- 2004: 1
- 2007: 1
- 2009: 1
- 2010: 2
- 2012: 1
- 2013: 3
- 2017: 1
- 2024: 1
- 2026: 1

## Most-cited predicates
- K882629: Directigen Respiratory Syncytial Virus Test Kit (1988), cited by 4
- K022133: BD Directigen EZ RSV Kit (2002), cited by 3
- K032166: Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack, Model 400-065 (2003), cited by 2
- K101918: Quickvue RSV 10 (2010), cited by 2
- K130398: Sofia (R) RSV Fia (2013), cited by 1
- K240280: Nano-Check™ RSV Test (2024), cited by 1
- K121633: BD Veritor (TM) System for the Rapid Detection of RSV (2012), cited by 1
- K070747: Quick Vue RSV Test, Models 20193, 20199 (2007), cited by 1
- K041445: Immunocard Stat! RSV Model #750630 (2004), cited by 1
- K023779: RSV Oia (2003), cited by 1

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