# K112236: Wondfo Methylenedioxymethamphetamine Urine Test, Wondfo Morphine Urine Test

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Wondfo Biotech Co., Ltd.
- Decided: Sep 19, 2011 after 46 days
- Product code: LAF (Gas Chromatography, Methamphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3610
- 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.
No later device cites it as a predicate yet.
0 of 3 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.
- K022589: Acon Mdma One Step Ecstasy Test Strip & Acon Mdma One Step Ecstasy Test Device, ACON Laboratories, Inc. (2002) Summary page 1.

## Indications for use
Wondfo Methylenedioxymethamphetamine Urine Test Is an immunochromatographic assay for the qualitative determination of MDMA In human urine at a cutoff concentration of 500ng/ml. 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 resultL GC/MS 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. Wondfo Morphine Urine Test is an immunochromatographic assay for the qualitative determination of Morphine In human urine at a cutoff concentration, of 300ng/mL. 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 resultL GC/MS 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/K112236
Methodology: https://510kreport.com/methodology