# CFN: Method, Nephelometric, Immunoglobulins (G, A, M)

- Device class: 2; regulation: 21 CFR 866.5510; FDA's rule: 510(k) required
- FDA decisions: 61
- 510(k) review time 2021–2025: median 251 days (middle half 140–363)
- Recalls: 13 (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)
- 2008: 7
- 2009: 4
- 2010: 2
- 2012: 1
- 2013: 4
- 2014: 2
- 2015: 1
- 2017: 1
- 2019: 6
- 2023: 2

## Most-cited predicates
- K860894: Behring Nephelometer System (1986), cited by 17
- K042735: N Antisera to Human Immunoglobulins (Igg, Iga and Igm) (2005), cited by 6
- K993549: Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin a (Igalc) Reagent, Beckman Coulter Cerebr (2000), cited by 3
- K993547: Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin M (Igmlc) Reagent, Beckman Coulter Cereb (2000), cited by 2
- K073490: Olympus Igg Reagent (2008), cited by 2
- K103824: Human Iga Liquid Reagent Kit for Use on Spa Plus (2012), cited by 2
- K082129: Human Igm Liquid Reagent Kit for Use on the Spaplus Analyzer (2009), cited by 2
- K162208: DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent (2017), cited by 1
- K072889: Human Igg Subclass Liquid Reagent Kits for Use on the Spaplus Analyser (2008), cited by 1
- K933971: N-Assay Tia Iga (1994), cited by 1

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