# CFF: Immunoelectrophoretic, Immunoglobulins, (G, A, M)

- Device class: 2; regulation: 21 CFR 866.5510; FDA's rule: 510(k) required
- FDA decisions: 29
- 510(k) review time 2021–2025: median 381 days (middle half 381–381)
- Recalls: 3 (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)
- 2003: 3
- 2006: 1
- 2009: 2
- 2011: 1
- 2012: 2
- 2015: 1
- 2016: 1
- 2018: 1
- 2019: 2
- 2021: 1

## Most-cited predicates
- K960669: Hydragel IF, 6 IF, 12 IF Penta Kits/Hydragel IF, Double IF, 2 IF, & 4 IF Kits (1996), cited by 4
- K823884: Paragon Immunoelectrophoresis Reagent (1983), cited by 2
- K082388: Minicap Immunotyping, Model: 2300 (2009), cited by 1
- K161928: Capi 3 Immunotyping, Capillarys 3 Tera, IT/IF Control (2016), cited by 1
- K172195: HYDRASHIFT 2/4 daratumumab, daratumumab Control (2018), cited by 1
- K103757: Immunofixation Electrophoresis Test Using Interlab G26 Instrument (2011), cited by 1
- K002799: Paragon Cze 2000 Capillary Electrophoresis System and Buffer-100 (2000), cited by 1
- K082085: Capillarys Immunotyping, Model 2100 (2009), cited by 1

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