# GTY: Antigens, All Groups, Streptococcus Spp.

- Device class: 1; regulation: 21 CFR 866.3740; FDA's rule: 510(k) exempt
- FDA decisions: 44
- 510(k) review time 2021–2025: median 194 days (middle half 185–202)
- Recalls: 6 (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)
- 2004: 1
- 2005: 1
- 2008: 1
- 2009: 1
- 2013: 2
- 2014: 2
- 2017: 1
- 2022: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K133343: Wondfo Rapid Strep a Test (2014), cited by 2
- K040708: Status First Strep a (2004), cited by 1
- K936112: Strep B Oia (1994), cited by 1
- K011097: Quickvue Dipstick Strep a (2001), cited by 1
- K123793: Sofia Strep a Fia (2013), cited by 1
- K992658: Osom Ultra Strep a Test, Model 147 (2000), cited by 1
- K091489: Clearview Advanced Strep a , Model 737-430 (2009), cited by 1
- K922490: Abbott Strep a Controls (1992), cited by 1
- K991828: Strep B Oia (1999), cited by 1
- K141775: Sofia (R) Strep a+ Fia (2014), cited by 1

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