# KLS: Enzyme Immunoassay, Theophylline

- Device class: 2; regulation: 21 CFR 862.3880; FDA's rule: 510(k) required
- FDA decisions: 71
- 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)
- 1991: 3
- 1993: 3
- 1994: 1
- 1995: 3
- 1996: 1
- 1997: 2
- 2000: 1
- 2001: 2
- 2002: 2
- 2004: 2

## Most-cited predicates
- K853872: Emit Caffeine Assay (1986), cited by 2
- K862955: Methods for the Dimension Clinical Chem. System (1986), cited by 1
- K961462: Cedia Theophylline Assay (1996), cited by 1
- K913123: Emit (R) 2000 Theophylline Assay/Calibrators (1991), cited by 1
- K952596: Theophylline Enzyme Immunoassay (1995), cited by 1

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