# K130665: Wondofo Multi-Drug Urine Test Cup / Panel

- Pathway: 510(k) (Special)
- Applicant: Guangzhou Wondfo Biotech Co., Ltd.
- Decided: Apr 9, 2013 after 28 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: none
- 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.
4 later devices descend from it; 3 cite it directly.
0 of 7 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)

## Most influential descendants
- 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 Multi-Drug Urine Test Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Morphine 2000, Phencyclidine, Oxycodone and Buprenorphine in human urine at the cutoff concentrations of: Drug (Identifier) — Cut-off level 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 Morphine 2000 (OPI) — 2000 ng/mL Phencyclidine (PCP) — 25 ng/mL Oxycodone (OXY) — 100 ng/mL Buprenorphine (BUP) — 10 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 will yield preliminary positive results when prescription drugs Buprenorphine, 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 immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Morphine 2000, Phencyclidine, Oxycodone and Buprenorphine in human urine at the cutoff concentrations of: Drug (Identifier) — Cut-off level 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 Morphine 2000 (OPI) — 2000 ng/mL Phencyclidine (PCP) — 25 ng/mL Oxycodone (OXY) — 100 ng/mL Buprenorphine (BUP) — 10 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 will yield preliminary positive results when prescription drugs Buprenorphine, 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/K130665
Methodology: https://510kreport.com/methodology