# K122904: Wondfo Multi-Drug Urine Test Cup Model W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU;

- Pathway: 510(k) (Special)
- Applicant: Guangzhou Wondfo Biotech Co., Ltd.
- Decided: Nov 15, 2012 after 55 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K150179: CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids (2015), 1 descendant of its own
- K143535: CR3 Keyless Split Sample Cup Secobarbital- Methadone (2015), 1 descendant of its own
- K151478: Wondfo CR3 Keyless Split Sample Cup (2015), 0 descendants of its own

## Indications for use
Wondfo Multi-Ding Urine Test Cup is competitive binding, lateral flow inmmochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Phencyclidine, Notriptyline and Oxycodone in human urine at the cutoff concentrations of: Drug(Identifier) Cut-off level Axnphetamine(AMP) 1000 ng/mL Secobarbital (BAR) 300 nglmL Oxazepam (BZO) 300 ng/mL Cocaine (COC) 300 ng/mL Cannabinoids (THC) 50 nglmL Methamphetamine (MET) 1000 nglmL Methylenedioxymethamphetamine (MDMA) 500 nglmL Morphine (MOP) 300 ng/mL Methadone (MTD) 300 nglmL Phencyclidine (PCP) 25 nglmL Notriptyline (ICA) 1000 nglmL Oxycodane (OXY) 100 ng/mL Configuration of the Wondfo Multi-Drug Urine Test Cup can consist of any combination of the above listed drug analytes. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GCIMS or LC/MS is the preferred confirmatory method. The test will yield preliminary positive results when prescription drugs Notriptyline, Oxazepam, Oxycodone and Secobarbital are ingested, even at or above therapeutic doses. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. Wondfo Multi-Drug Urine Test Panel is competitive binding, lateral flow rimunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Phencyclidine, Notriptyline and Oxycodone in human urine at the cutoff concentrations of: Drug(Identifier) Cut-off level Amphetamine(AMP) 1000 nglmL Secobarbital (BAR) 300 ng/mL Oxazepamn (BZO) 300 nglmL Cocaine (COC) 300 ng/mL Cannabinoids (THC) 50 nglmL Methamphetanine (MET) 1000 ng/mL Methylenedioxymethaniphetamine (MDMA) 500 ng/mL Morphine (MOP) 300 ng/mL Methadone (MTD) 300 nglmL Phencyclidine (PCP) 25 ng/mL Notriptyline (TCA) 1000 nglmL Oxycodone (OXY) 100 nglmL Configuration of the 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 chemical method must be used in order to obtain a confirmed analytical result. GCIMS or LC/MS is the preferred confirmatory method. The test will yield preliminary positive results when prescription drugs Notriptyline, Oxazepam, Oxycodone and Secobarbital are ingested, even at or above therapeutic doses. 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/K122904
Methodology: https://510kreport.com/methodology