# K133968: Wondfo Multi-Drug Urine Test Cup, Panel

- Pathway: 510(k) (Special)
- Applicant: Guangzhou Wondfo Biotech Co., Ltd.
- Decided: Feb 25, 2014 after 61 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations 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)
- K112071: Wondfo Cocaine Urine Test Model W10-CU, W10-P, Wondfo Methamphetamine Urine Test Model W11-CU, W11-P, Guangzhou Wondfo Biotech Co., Ltd. (2011) Summary page 3.

## Recalls of this device
- May 25, 2022 · Class II · Z-1589-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

## Indications for use
Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Phencyclidine, Oxycodone, Buprenorphine, Methadone and Notriptyline in human urine at the cutoff concentrations of: Amphetamine (AMP): 1000 ng/mL Secobarbital (BAR): 300 ng/mL Oxazepam (BZO): 300 ng/mL Cocaine (COC): 300 ng/mL Cannabinoids (THC): 50 ng/mL Methamphetamine (MET): 1000 ng/mL Methylenedioxymethamphetamine (MDMA): 500 ng/mL Morphine (MOP): 300 ng/mL Phencyclidine (PCP): 25 ng/mL Oxycodone (OXY): 100 ng/mL Buprenorphine (BUP): 10 ng/mL Methadone (MTD): 300 ng/mL Notriptyline (TCA): 1000 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. GC/MS or LC/MS is the preferred confirmatory method. The test may yield positive results for the prescription drugs buprenorphine, oxazepam, oxycodone, and secobarbital when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use. Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Phencyclidine, Oxycodone, Buprenorphine, Methadone and Notriptyline in human urine at the cutoff concentrations of: Amphetamine (AMP): 1000 ng/mL Secobarbital (BAR): 300 ng/mL Oxazepam (BZO): 300 ng/mL Cocaine (COC): 300 ng/mL Cannabinoids (THC): 50 ng/mL Methamphetamine (MET): 1000 ng/mL Methylenedioxymethamphetamine (MDMA): 500 ng/mL Morphine (MOP): 2000 ng/mL Phencyclidine (PCP): 25 ng/mL Oxycodone (OXY): 100 ng/mL Buprenorphine (BUP): 10 ng/mL Methadone (MTD): 300 ng/mL Notriptyline (TCA): 1000 ng/mL 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. GC/MS or LC/MS is the preferred confirmatory method. The test may yield positive results for the prescription drugs buprenorphine, oxazepam, oxycodone, and secobarbital when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Source page: https://510kreport.com/device/K133968
Methodology: https://510kreport.com/methodology