# K222667: Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx

- Pathway: 510(k) (Traditional)
- Applicant: Vivachek Biotech (Hangzhou) Co., Ltd.
- Decided: Nov 10, 2022 after 65 days
- Product code: NFT (Test, Amphetamine, Over The Counter)
- 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
Longest line of descent: 7 generations back to K945610 (1995). 28 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182701: Wondfo T-Cup Multi-Drug Urine Test Cup, Guangzhou Wondfo Biotech Co., Ltd. (2018) Summary page 8.

## Most influential descendants
- K252554: Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup (2025), 0 descendants of its own

## Indications for use
Wisdiag Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: Drug (Identifier) — Cut-off level Amphetamine (AMP) — 1000 ng/mL or 500 ng/mL Buprenorphine (BUP) — 10 ng/mL Secobarbital (BAR) — 300 ng/mL Oxazepam (BZO) — 300 ng/mL Cocaine (COC) — 300 ng/mL or 150 ng/mL 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) — 300 ng/mL Methamphetamine (MET) — 1000 ng/mL or 500 ng/mL Methylenedioxymethamphetamine (MDMA) — 500 ng/mL Morphine (MOP 300/OPI 2000) — 2000 ng/mL or 300 ng/mL Methadone (MTD) — 300 ng/mL Oxycodone (OXY) — 100 ng/mL Phencyclidine (PCP) — 25 ng/mL Propoxyphene (PPX) — 300 ng/mL Nortriptyline (TCA) — 1000 ng/mL Marijuana (THC) — 50 ng/mL Wisdiag Multi-Drug Urine Test Cup offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone 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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method. Wisdiag Multi-Drug Urine Test Cup Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of: Drug (Identifier) — Cut-off level Amphetamine (AMP) — 1000 ng/mL or 500 ng/mL Buprenorphine (BUP) — 10 ng/mL Secobarbital (BAR) — 300 ng/mL Oxazepam (BZO) — 300 ng/mL Cocaine (COC) — 300 ng/mL or 150 ng/mL 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) — 300 ng/mL Methamphetamine (MET) — 1000 ng/mL or 500 ng/mL Methylenedioxymethamphetamine (MDMA) — 500 ng/mL Morphine (MOP 300/OPI 2000) — 2000 ng/mL or 300 ng/mL Methadone (MTD) — 300 ng/mL Oxycodone (OXY) — 100 ng/mL Phencyclidine (PCP) — 25 ng/mL Propoxyphene (PPX) — 300 ng/mL Nortriptyline (TCA) — 1000 ng/mL Cannabinoids (THC) — 50 ng/mL Wisdiag Multi-Drug Urine Test Cup Rx offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for prescription use. The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone 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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

Source page: https://510kreport.com/device/K222667
Methodology: https://510kreport.com/methodology