# DBF: Ferritin, Antigen, Antiserum, Control

- Device class: 2; regulation: 21 CFR 866.5340; FDA's rule: 510(k) required
- FDA decisions: 87
- 510(k) review time 2021–2025: median 624 days (middle half 624–624)
- Recalls: 4 (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)
- 2005: 1
- 2006: 3
- 2009: 1
- 2010: 1
- 2011: 1
- 2012: 1
- 2014: 1
- 2017: 1
- 2020: 1
- 2021: 1

## Most-cited predicates
- K950707: N Latex Ferritin (1995), cited by 2
- K050944: K-Assay Ferritin (2) & Ferritin Calibrator Set (2005), cited by 2
- K905770: Ciba Corning Acs Ferritin Immunoassay (1991), cited by 1
- K935847: Axsym Ferritin (1994), cited by 1
- K993273: N Latex Ferritin (1999), cited by 1
- K040879: Quantex Ferritin (2004), cited by 1
- K992157: Chiron Diagnostics Acs: 180 Ferritin Assay (1999), cited by 1
- K030124: Olympus Ferritin Reagent (2003), cited by 1
- K860137: Enzymun-Test Ferritin (1986), cited by 1
- K092505: Beckman Coulter Ferritin Reagent, Model: OSR61203 (2009), cited by 1

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