# KXT: Enzyme Immunoassay, Digoxin

- Device class: 2; regulation: 21 CFR 862.3320; FDA's rule: 510(k) required
- FDA decisions: 85
- 510(k) review time 2021–2025: median 588 days (middle half 588–588)
- Recalls: 5 (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)
- 1998: 4
- 2001: 3
- 2002: 1
- 2003: 1
- 2006: 1
- 2008: 1
- 2010: 1
- 2011: 1
- 2016: 1
- 2021: 1

## Most-cited predicates
- K882233: TDX (R) Digoxin NXT (1988), cited by 7
- K851032: Cobas FP Reagents for Digoxin & Cobas FP Digoxin C (1985), cited by 1
- K982935: Synchron Systems Digoxin (Dign) Reagent, Synchron Systems Drug Calibrator (1998), cited by 1
- K973112: Elecsys Digoxin (1997), cited by 1
- K023058: QMS Digoxin Reagent System on the Abbott Aeroset System (2002), cited by 1
- K931213: Acs Digoxin Immunoassay (1993), cited by 1
- K946153: Digoxin Flex (TM) Reagent Cartridge (1995), cited by 1
- K953718: Axsym Digoxin II (1995), cited by 1
- K910642: Cedia (R) Digoxin SC Assay (1991), cited by 1

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