# NGZ: Susceptibility Test Plate, Antifungal

- Device class: 2; regulation: 21 CFR 866.1640; FDA's rule: 510(k) required
- FDA decisions: 21
- 510(k) review time 2021–2025: median 211 days (middle half 155–263)
- 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)
- 2006: 1
- 2009: 3
- 2010: 2
- 2014: 3
- 2016: 2
- 2018: 1
- 2021: 1
- 2023: 3
- 2024: 2
- 2025: 1

## Most-cited predicates
- K092454: Vitek 2 Yeast Voriconazole (2010), cited by 2
- K133952: Vitek 2 Ast YS Flucytosine, Vitek 2 Ast Yeast Flucytosine (2014), cited by 2
- K133817: Vitek 2 Ast - Yeast Fluconazole (2014), cited by 1
- K991810: Modification to Sensititre Yeastone Mic Susceptibility Test (2001), cited by 1
- K061945: Vitek 2 Ast-YS Fluconazole (2006), cited by 1
- K151817: VITEK 2  AST-YS Caspofungin <=0.125 - >=8 ug/mL (2016), cited by 1
- K151923: VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) (2016), cited by 1

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