# MYI: System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies

- Device class: 2; regulation: 21 CFR 866.1640; FDA's rule: 510(k) required
- FDA decisions: 10
- Recalls: 0 (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)
- 1999: 1
- 2001: 1
- 2002: 2
- 2006: 1
- 2010: 2
- 2012: 1
- 2014: 2

## Most-cited predicates
- K011710: Oxoid PBP2 1 Latex Agglutination Test (2002), cited by 5
- K091766: Clearview Exact PBP2A Test, Model 891-000 (2010), cited by 2
- K011400: Mrsa-Screen (2002), cited by 1
- K090301: Binaxnow PBP2A Test, Model 890-000 (2010), cited by 1

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