# DBL: Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

- Device class: 2; regulation: 21 CFR 866.5660; FDA's rule: 510(k) required
- FDA decisions: 24
- 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
- 1990: 1
- 1991: 1
- 1993: 1
- 1994: 1
- 1995: 2
- 1996: 3
- 1997: 2
- 1998: 2
- 2018: 1

## Most-cited predicates
- K792610: Kallestad Florescent Ana/Ama/Asma Test (1980), cited by 7
- K902237: Medica Iif Anti-Skin Antibody Test Kit (1990), cited by 1
- K891098: Anti-Skin Antibody Test (Monkey Esophagus Sections) (1989), cited by 1
- K974169: Wielisa Anti-GBM Test System (1998), cited by 1
- K891099: Anti-Skin Antibody Test (Monkey/Guin Pig Esoph Sec) (1989), cited by 1

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