# JXN: Enzyme Immunoassay, Propoxyphene

- Device class: 2; regulation: 21 CFR 862.3700; FDA's rule: 510(k) required
- FDA decisions: 22
- 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)
- 1998: 1
- 2000: 1
- 2001: 1
- 2002: 3
- 2003: 2
- 2004: 1
- 2005: 1
- 2011: 1
- 2013: 1
- 2015: 1

## Most-cited predicates
- K040445: Acon PPX One Step Propoxyphene Test Strip and Acon PPX Step Propoxyphene Test Device (2004), cited by 5
- K022915: Instant-View Propoxyphene (PPX) Urine Test (2002), cited by 2
- K943414: Propoxphene Eia Test (1994), cited by 1
- K023795: Propoxyphene Enzyme Immunoassay, Catalog #0120 (500 Test Kit), #0121 (5000 Test Kit) (2003), cited by 1
- K983700: Modification to Abuscreen Online for Propoxyphene (1998), cited by 1
- K945195: Abuscreen Online Propoxphene (1994), cited by 1
- K923873: Syva Emit II Propoxyphene Assay (1992), cited by 1
- K020787: Verdict-II Propoxyphene (2002), cited by 1

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