# K112071: Wondfo Cocaine Urine Test Model W10-CU, W10-P, Wondfo Methamphetamine Urine Test Model W11-CU, W11-P

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Wondfo Biotech Co., Ltd.
- Decided: Sep 23, 2011 after 65 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- 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). 1 ancestor in all.
6 later devices descend from it; 2 cite it directly.
0 of 8 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.

## Most influential descendants
- K130665: Wondofo Multi-Drug Urine Test Cup / Panel (2013), 4 descendants of its own
- K142044: CR3 Keyless Split Sample Cup Phencyclidien - Methylenedioxymethamphetamine (2014), 1 descendant of its own
- K141532: CR3 Keyless Split Sample Cup Amphetamine-Cocaine (2014), 1 descendant of its own
- K140089: CR3 Keyless Split Sample Cup (Opi-Bzo) (2014), 1 descendant of its own
- K151478: Wondfo CR3 Keyless Split Sample Cup (2015), 0 descendants of its own

## Indications for use
Wondfo Cocaine Urine Test is an immunochromatographic assay for the qualitative determination of Benzoylecgonine 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 result. 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 Methamphetamine Urine Test is an immunochromatographic assay for the qualitative determination of D(+)-Methamphetamine in human urine at a cutoff concentration of 1000 ng/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 result. 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/K112071
Methodology: https://510kreport.com/methodology