# LFG: Radioimmunoassay, Tricyclic Antidepressant Drugs

- Device class: 2; regulation: 21 CFR 862.3910; FDA's rule: 510(k) required
- FDA decisions: 21
- Recalls: 2 (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
- 1998: 1
- 2001: 1
- 2002: 1
- 2006: 1
- 2007: 1
- 2011: 1
- 2014: 1
- 2015: 1

## Most-cited predicates
- K021526: Acon Tca One Step Tricyclic Antidepressant Test Strip and Device (2002), cited by 5
- K151348: Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card) (2015), cited by 2
- K142609: CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine (2014), cited by 1
- K980249: Accusign Tca, Biosign Tca, Staus DS Tca (1998), cited by 1

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