# K131754: Wondfo Cocaine Urine Test (Coc 100), Wondfo Cannabinoids Urine Test (THC 40)

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Wondfo Biotech Co., Ltd.
- Decided: Jul 31, 2013 after 47 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 K050394 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050394: Sure-Screen Amphetamine, Benzodiazepine, Cocaine, Methamphetamine/Mdma, Methadone, Opiates, Phencyclidine & Cannabinoids, Medtox Diagnostics, Inc. (2005) Summary page 2.

## Indications for use
Wondfa Cocaine Urine Test (COC 100) is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 100 ng/mL. The test is available in a Dip Card format and a Cup format. This product is only intended for prescription use and is not intended for point-of-care 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. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. Wondfo Cannabinoids Urine Test (THC 40) is an immunochromatographic assay for the qualitative determination of 11-nor-A9-THC-9-COOH in human urine at a Cut-Off concentration of 40 ng/mL. The test is available in a Dip Card format and a Cup format. This product is only intended for prescription use and is not intended for point-of-care 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. Clinical consideration and professional judgment should be exercised wit any drug of abuse test result, particularly when the preliminary result is positive.

Source page: https://510kreport.com/device/K131754
Methodology: https://510kreport.com/methodology