# K252554: Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup

- Pathway: 510(k) (Traditional)
- Applicant: Vivachek Biotech (Hangzhou) Co., Ltd.
- Decided: Sep 12, 2025 after 30 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: 8 generations back to K945610 (1995). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222667: Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx, Vivachek Biotech (Hangzhou) Co., Ltd. (2022) Summary page 7.

## 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, Marijuana, Tramadol, Fentanyl, 6-Monoacetylmorphine and Norfentanyl in human urine at the cutoff concentrations of: Drug (Identifier) Cut-off level Amphetamine (AMP) 500 ng/mL or 1000 ng/mL Buprenorphine (BUP) 10 ng/mL Secobarbital (BAR) 300 ng/mL Oxazepam (BZO) 300 ng/mL Cocaine (COC) 150 ng/mL or 300 ng/mL 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 300 ng/mL Methamphetamine (MET) 500 ng/mL or 1000 ng/mL Methylenedioxymethamphetamine (MDMA) 500 ng/mL Morphine (MOP 300/OPI 2000) 300 ng/mL or 2000 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 Tramadol (TML) 100 ng/mL Fentanyl (FYL) 1 ng/mL 6-Monoacetylmorphine (6-MAM) 10 ng/mL Norfentanyl (NFYL) 5 ng/mL The single or multi-test cups can consist of up to nineteen (19) of the above listed analytes in any combination but only one cutoff concentration under same drug condition will be included per device with or without on-board adulteration/specimen validity tests (SVT). 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. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results. Wisdiag Multi-Drug Urine Home 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, Marijuana, Tramadol, Fentanyl, 6-Monoacetylmorphine and Norfentanyl in human urine at the cutoff concentrations of: Drug (Identifier) Cut-off level Amphetamine (AMP) 500 ng/mL or 1000 ng/mL Buprenorphine (BUP) 10 ng/mL Secobarbital (BAR) 300 ng/mL Oxazepam (BZO) 300 ng/mL Cocaine (COC) 150 ng/mL or 300 ng/mL 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 300 ng/mL Methamphetamine (MET) 500 ng/mL or 1000 ng/mL Methylenedioxymethamphetamine (MDMA) 500 ng/mL Morphine (MOP 300/OPI 2000) 300 ng/mL or 2000 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 Tramadol (TML) 100 ng/mL Fentanyl (FYL) 1 ng/mL 6-Monoacetylmorphine (6-MAM) 10 ng/mL Norfentanyl (NFYL) 5 ng/mL Wisdiag Multi-Drug Urine Home Test Cup offers any combinations from 1 to 19 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 to be over-the-counter use. 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. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

Source page: https://510kreport.com/device/K252554
Methodology: https://510kreport.com/methodology