# LGS: Fluorescence Polarization Immunoassay, Theophylline

- Device class: 2; regulation: 21 CFR 862.3880; FDA's rule: 510(k) required
- FDA decisions: 13
- 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)
- 1985: 2
- 1987: 2
- 1989: 1
- 1990: 1
- 1992: 1
- 1993: 1
- 1994: 1
- 1995: 2
- 1996: 1
- 2007: 1

## Most-cited predicates
- K932127: TDX/Tdxflx & Tdxflx Theophylline Monoclonal II (1993), cited by 2
- K922991: Abbott TDX/Tdxflx and Tdxflx Theophylline (1992), cited by 1
- K953016: Axsym Theophylline II (1995), cited by 1
- K871484: Cobas FP Reagents for Theophylline & Calibrators (1987), cited by 1
- K951169: Ciba Corining Acs Theophylline Immunoassay (1995), cited by 1

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