# LAR: Enzyme Immunoassay, Procainamide

- Device class: 2; regulation: 21 CFR 862.3320; FDA's rule: 510(k) required
- FDA decisions: 25
- Recalls: 0 (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)
- 1986: 1
- 1987: 1
- 1992: 1
- 1994: 2
- 1995: 1
- 1996: 4
- 1997: 1
- 2001: 1
- 2003: 1
- 2006: 1

## Most-cited predicates
- K834464: TDX Procainamide (1984), cited by 2
- K833384: Procainamide Analytical Test Pack (1983), cited by 1
- K942847: Cobas (R)-FP Reagent for Procainamide/Calibrator (1994), cited by 1
- K852320: Cobas FP Reagen for Procainamide & Pro Calibrator (1985), cited by 1
- K032573: Dimension Procainamide (Proc) Flex Reagent Cartridge Method, Model DF110 (2003), cited by 1

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