# DCF: Albumin, Antigen, Antiserum, Control

- Device class: 2; regulation: 21 CFR 866.5040; FDA's rule: 510(k) exempt
- FDA decisions: 37
- 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)
- 2005: 1
- 2006: 2
- 2009: 1
- 2010: 3
- 2011: 1
- 2012: 1
- 2013: 1
- 2014: 1
- 2015: 1
- 2016: 1

## Most-cited predicates
- K100853: Cobas 8000 Modular Series Analyzer (2010), cited by 9
- K780913: Additional Reagents Kits for Imm. System (1978), cited by 7
- K972929: N Antiserum to Human Albumin (1997), cited by 4
- K101203: Tina-Quant Albumin Gen 2 (2010), cited by 1
- K961824: Cobas Integra Reagent Cassettes for Albumin, Hbalc and Digoxin (1996), cited by 1
- K082251: Synchron Systems Microalbumin (MA) Reagent, Model 475100 (2009), cited by 1
- K061990: Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3 Calibrator; Protein 3 Control (2006), cited by 1
- K964695: Immage Immunochemistry System Albumin (Alb) Reagent (1997), cited by 1

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