# K121166: Wondfo Multi-Drug Urine Test Cup Wondfo Multi-Drug Urine Test Panel

- Pathway: 510(k) (Special)
- Applicant: Guangzhou Wondfo Biotech Co., Ltd.
- Decided: May 8, 2012 after 21 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Wondfo single DOA Tests: named in the summary without a submission number

## Most influential descendants
- K130275: Quikscreen Multi (Mdma and Opi) Otc Drug Cup Test (2013), 0 descendants of its own

## Indications for use
Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel are competitive binding, lateral flow lmmunochromatographic assays for qualitative and simultaneous detection of Cocaine, Methadone, Methamphetamine, Methylenedioxymethamphetamnine, Morphine, Morphine 2000, Phencyclidine, Notriptyline in human urine at the cutoff concentrations of: Configuration of the Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel can consist of any combination of the above listed drug analytes. The test provides only preliminary test results. A more specific alternative chenilcal method must be used in order to obtain a confirmed analytical result GC/MS or LCIMS 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/K121166
Methodology: https://510kreport.com/methodology