# JFM: Enzymatic Method, Bilirubin

- Device class: 2; regulation: 21 CFR 862.1110; FDA's rule: 510(k) required
- FDA decisions: 11
- Recalls: 1 (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)
- 1984: 1
- 1990: 1
- 1997: 1
- 2005: 4
- 2007: 1
- 2016: 2
- 2017: 1

## Most-cited predicates
- K970985: Wako Total Bilirubin V (1997), cited by 3
- K053132: Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791 (2005), cited by 2
- K843174: Dri-Stat Enzymatic Bilirubin Test Kit (1984), cited by 1
- K063845: Advia Chemistry Total Bilirubin_2 (2007), cited by 1

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