# GTZ: Antisera, All Groups, Streptococcus Spp.

- Device class: 1; regulation: 21 CFR 866.3740; FDA's rule: 510(k) exempt
- FDA decisions: 105
- 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)
- 1991: 4
- 1992: 4
- 1993: 2
- 1994: 3
- 1995: 7
- 1996: 6
- 1997: 1
- 1998: 1
- 1999: 1
- 2001: 3

## Most-cited predicates
- K934484: Quickvue in-Line One-Step Strep a Test (1994), cited by 1
- K954257: Quickvue in-Line One Step Strep a Test (Modification) (1995), cited by 1
- K854929: Oxoid Streptococal Grouping Kit (1986), cited by 1
- K901274: Testpack Plus Strep a (1990), cited by 1
- K922345: Testpack Plus Strep a (1992), cited by 1
- K991726: Binax Nowr Streptococcus Pneumoniae Urinary Antigen Test (22 Test Kit),(12 Test Kit), Binax Nowr Streptococcus Pneumoni (1999), cited by 1
- K012521: Binax Now Streptococcus Pneumoniae Test (2001), cited by 1

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