# DBI: Complement C4, Antigen, Antiserum, Control

- Device class: 2; regulation: 21 CFR 866.5240; FDA's rule: 510(k) required
- FDA decisions: 34
- 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)
- 1989: 2
- 1991: 1
- 1992: 1
- 1996: 2
- 1997: 2
- 1998: 1
- 1999: 2
- 2000: 2
- 2001: 2
- 2010: 1

## Most-cited predicates
- K964297: N-Assay Tia C4 Test Kit (1997), cited by 1
- K920010: IL Test Complement 4 (1992), cited by 1

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