# K023795: Propoxyphene Enzyme Immunoassay, Catalog #0120 (500 Test Kit), #0121 (5000 Test Kit)

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Jan 21, 2003 after 69 days
- Product code: JXN (Enzyme Immunoassay, Propoxyphene)
- Device class: 2
- Regulation: 21 CFR 862.3700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K943414 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943414: Propoxphene Eia Test, Diagnostic Reagents, Inc. (1994) Summary page 1.

## Most influential descendants
- K033885: BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit) (2004), 0 descendants of its own

## Indications for use
The Propoxyphene Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of propoxyphene in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers. The Propoxyphene Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GCMS) is the preferred confirmatory method. Clinical consideration and professional judgement should be applied to any dmg-of-abuse test result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K023795
Methodology: https://510kreport.com/methodology