# K152495: Wondfo Propoxyphene Urine Test

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Wondfo Biotech Co., Ltd.
- Decided: Nov 23, 2015 after 83 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: 2 generations back to K020771 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121557: Wondfo Cannabinoids Urine Test Wondfo Propoxyphene Urine Test, Guangzhou Wondfo Biotech Co., Ltd. (2012) Summary page 4.

## Indications for use
Wondfo Propoxyphene Urine Test is an immunochromatographic assay for the qualitative determination of d-Propoxyphene in human urine at a cutoff concentration of 300 ng/mL. The test is available in a dip card format and a test cup format. It is intended for prescription use and over the counter use. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. The test will yield preliminary positive results when prescription drug d-Propoxyphene is ingested, even at or above therapeutic doses. There is no uniformly recognized cutoff concentration for d-Propoxyphene. It is not intended to distinguish between prescription use or abuse of this drug. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

Source page: https://510kreport.com/device/K152495
Methodology: https://510kreport.com/methodology