# GTQ: Antistreptolysin - Titer/Streptolysin O Reagent

- Device class: 1; regulation: 21 CFR 866.3720; FDA's rule: 510(k) exempt
- FDA decisions: 37
- Recalls: 4 (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)
- 1986: 1
- 1987: 1
- 1988: 1
- 1989: 3
- 1990: 1
- 1991: 8
- 1992: 3
- 1993: 2
- 1995: 1
- 2005: 1

## Most-cited predicates
- K926236: Beckman Anti-Streptolysin O Kit (1993), cited by 2
- K894486: Quantex Aso Plus (Latex,Buffer Standard,Control) (1989), cited by 1
- K052645: Vitros Chemistry Products Calibrator Kit 28, Ref 680 2323; Vitros Chemistry Products FS Calibrator 1, Ref 6801873; (2005), cited by 1

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