# LCD: Enzyme Immunoassay, Gentamicin

- Device class: 2; regulation: 21 CFR 862.3450; FDA's rule: 510(k) required
- FDA decisions: 37
- 510(k) review time 2021–2025: median 239 days (middle half 239–239)
- Recalls: 8 (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)
- 1991: 1
- 1994: 2
- 1995: 2
- 1996: 2
- 2001: 3
- 2002: 1
- 2005: 1
- 2006: 1
- 2011: 1
- 2025: 1

## Most-cited predicates
- K935376: Axsym Gentamicin (1994), cited by 2
- K102699: Architect Igentamicin Reagents; Architect Igentamicin Calibrators (2011), cited by 1
- K962519: Emit 2000 Gentamicin Assay and Calibrators (1996), cited by 1
- K962819: Gentamicin Flex Reagent Cartridge (1996), cited by 1
- K913470: Cedia (R) Gentamicin Assay (1991), cited by 1

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