# K121557: Wondfo Cannabinoids Urine Test Wondfo Propoxyphene Urine Test

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Wondfo Biotech Co., Ltd.
- Decided: Jul 25, 2012 after 61 days
- Product code: LDJ (Enzyme Immunoassay, Cannabinoids)
- Device class: 2
- Regulation: 21 CFR 862.3870
- 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 K020771 (2002). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020771: Acon One Step Drug Screen Test Card, ACON Laboratories, Inc. (2002) Summary page 1.
- K040445: Acon PPX One Step Propoxyphene Test Strip and Acon PPX Step Propoxyphene Test Device, ACON Laboratories, Inc. (2004) Summary page 1.

## Most influential descendants
- K152495: Wondfo Propoxyphene Urine Test (2015), 0 descendants of its own

## Indications for use
Wondfo Propoxyphene Urine Test is an immunochromatogmaphic assay for the qualitative determination of d-Propoxyphene in human urine at a cutoff concentmation of 300 nglmL. The test is available in a dip card format and a cup format. This product is only intended for prescription use. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a conformed analytical result. GCIMS is the preferred confirmatory method. Clinical considemation and professional judgment should .be exercised with any drug of abuse test result, particularly when the preliminary result is positive. Wondfo Cannabinoids Urine Test is an immunochromatographic assay for the qualitative determination of 11-nor-AS-THC-9-COOH (major metabolite of Cannabinoids) in human urine at a cutoff concentration of 50 nglrnL. The test is available in a dip card format and a 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 conformed analytical result. GCIMS is the preferred confirmatory method. 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/K121557
Methodology: https://510kreport.com/methodology