# DHR: System, Test, Rheumatoid Factor

- Device class: 2; regulation: 21 CFR 866.5775; FDA's rule: 510(k) required
- FDA decisions: 144
- Recalls: 10 (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)
- 2007: 1
- 2009: 1
- 2010: 1
- 2011: 1
- 2015: 1
- 2016: 1
- 2017: 1
- 2018: 1
- 2019: 1
- 2020: 1

## Most-cited predicates
- K942328: N Latex RF (1994), cited by 4
- K002609: Tina-Quant Rheumatoid Factors II Test System (2000), cited by 2
- K983084: Quanta Lite RF Iga Elisa (1998), cited by 2
- K896271: Quantex RF Plus (Latex, Buffer Standard, Control) (1989), cited by 2
- K971614: Quanta Lite RF Igm (1997), cited by 2
- K963048: Immage System Rheumatoid Factor (RF) Reagent (1996), cited by 2
- K855221: Seratest RF (Hemagglutination) Kit (1986), cited by 2
- K032535: Modification to:Roche Diagnostics Tina-Quant Rheumatoid Factors II Test System (2003), cited by 1
- K160070: Rheumatoid Factor (RF) Kit for use on SPAPLUS (2016), cited by 1
- K810306: Rheumatoid Factor Reagent Test Kit (1981), cited by 1

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