# CGN: Acid, Folic, Radioimmunoassay

- Device class: 2; regulation: 21 CFR 862.1295; FDA's rule: 510(k) required
- FDA decisions: 64
- 510(k) review time 2021–2025: median 266 days (middle half 265–266)
- Recalls: 29 (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
- 2009: 2
- 2010: 1
- 2011: 1
- 2014: 1
- 2016: 1
- 2018: 1
- 2020: 1
- 2023: 1
- 2024: 1

## Most-cited predicates
- K935286: Quantaphase II B12/Folate (1994), cited by 5
- K060774: Folate on the Access Immunoassay Systems, Model A14208 (2006), cited by 4
- K082340: Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys Folate Iii Calset, Roche Elecsys (2009), cited by 3
- K010050: Advia Centaur and Acs: 180 Folate Immunoassay (2001), cited by 3
- K922823: Access Theophylline Immunoassay Reagents (1992), cited by 2
- K943705: Folic Acid (1994), cited by 1
- K981931: Cedia Red Blood Cell Folate Reagent Pack, Cedia Folate Assay and Elecsys Folate Assay (1998), cited by 1
- K031756: Roche Diagnostics Elecsys Folate II Assay (2003), cited by 1
- K092740: Architect Folate Reagents, Architect Folate Calibrators, and Architect Folate Controls, Models 1P74, 1P74, 1P74 (2010), cited by 1
- K103716: Roche Elecsys Folate RBC; Roche Elecsys Folate RBC Calset (2011), cited by 1

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