# K020787: Verdict-II Propoxyphene

- Pathway: 510(k) (Traditional)
- Applicant: Medtox Diagnostics, Inc.
- Decided: May 2, 2002 after 52 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K091454: Profile-V Medtoxscan Drugs of Abuse Test System (2009), 4 descendants of its own
- K220451: Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT (2023), 1 descendant of its own
- K250741: Evidence MultiSTAT DOA Urine MultiPlex (2026), 0 descendants of its own
- K221550: Evidence MultiSTAT DOA Urine MultiPlex (2023), 0 descendants of its own
- K100023: Profile-V Medtoxscan Drugs of Abuse Test System and 12 Drugs Test System (2010), 0 descendants of its own

## Indications for use
VERDICT®-II PROPOXYPHENE is a one-step immunochromatographic test for the rapid, qualitative detection of propoxyphene and its metabolite, norpropoxyphene, in human urine. The test detects the major urinary metabolite of propoxyphene (norpropoxyphene) at 300 ng/mL. It is not for over-the-counter sale. VERDICT®-II PROPOXYPHENE PROVIDES ONLY A PRELIMINARY ANALYTICAL TEST RESULT. A MORE SPECIFIC ALTERNATE CHEMICAL METHOD MUST BE USED IN ORDER TO OBTAIN A CONFIRMED ANALYTICAL RESULT. GAS CHROMATOGRAPHY/ MASS SPECTROMETRY (GC/MS) IS THE PREFERRED CONFIRMATORY METHOD. CLINICAL CONSIDERATION AND PROFESSIONAL JUDGMENT SHOULD BE APPLIED TO ANY DRUG OF ABUSE TEST RESULT, PARTICULARLY WHEN PRELIMINARY POSITIVE RESULTS ARE OBTAINED.

Source page: https://510kreport.com/device/K020787
Methodology: https://510kreport.com/methodology