# DCN: System, Test, C-Reactive Protein

- Device class: 2; regulation: 21 CFR 866.5270; FDA's rule: 510(k) required
- FDA decisions: 70
- 510(k) review time 2021–2025: median 212 days (middle half 151–272)
- 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)
- 2006: 1
- 2007: 1
- 2008: 2
- 2009: 3
- 2010: 1
- 2012: 1
- 2017: 1
- 2018: 3
- 2020: 1
- 2023: 2

## Most-cited predicates
- K003400: CRP HS Test System (2001), cited by 2
- K003342: Wako CRP-UL, CRP-UL Calibrator Set (2001), cited by 2
- K083444: C-Reactive Protein (Latex) (2009), cited by 2
- K073277: Roche-Creactive Protein (Latex) (2008), cited by 2
- K896272: Quantex CRP Plus (Latex, Buffer, Standard, Control (1989), cited by 1
- K003419: RCRP Flex Reagent Cartridge (2001), cited by 1
- K003372: Immulite High Sensitivity CRP, Immulite 2000 High Sensitivity CRP (2000), cited by 1
- K221119: RCRP Flex reagent cartridge (2023), cited by 1
- K032336: Tina-Quant CRP (Latex) (2003), cited by 1

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