Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup

K252554 · Vivachek Biotech (Hangzhou) Co., Ltd. · NFT · Sep 12, 2025 · Clinical Toxicology

Device Facts

• Record ID: K252554
• Device Name: Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup
• Applicant: Vivachek Biotech (Hangzhou) Co., Ltd.
• Product Code: NFT · Clinical Toxicology
• Decision Date: Sep 12, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

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: [Table of cut-offs]. 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: [Table of cut-offs]. 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 for 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.

Device Story

Rapid, single-use lateral flow immunochromatographic assay for qualitative detection of drugs of abuse in human urine. Device consists of a test cup containing test strips. Urine sample added to cup; migrates via capillary action. If drug concentration is below cutoff, drug-free antibody-coated particles bind to immobilized drug-conjugate, forming a visible colored test line. If drug concentration exceeds cutoff, binding sites are saturated, preventing test line formation. Control line indicates proper test performance. Used in clinical or home settings; operated by healthcare professionals or lay users. Results are visual; preliminary only. Confirmatory testing required for positive results. Benefits include rapid screening for drug presence.

Clinical Evidence

Bench testing only. Precision, interference, specificity, and method comparison studies performed. Method comparison against LC/MS using 80 samples per analyte. Lay-user study conducted with 280 participants (aged 20+) across three sites, demonstrating high agreement with LC/MS results across various concentrations. No clinical studies performed.

Technological Characteristics

Lateral flow immunochromatographic assay. Competitive binding principle. Single-use test cup format. No energy source required. Stable at 2-30°C for 30 months. No software or algorithm involved.

Indications for Use

Indicated for qualitative, simultaneous detection of 19 drugs of abuse (Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, EDDP, Methamphetamine, MDMA, Morphine, Methadone, Oxycodone, PCP, Propoxyphene, Nortriptyline, Marijuana, Tramadol, Fentanyl, 6-MAM, Norfentanyl) in human urine. Intended for professional (prescription) and over-the-counter (home) use. Provides preliminary results; requires confirmatory testing (GC/MS or LC/MS).

Regulatory Classification

Identification

An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION MEMORANDUM

510(k) Number: K252554

This 510(k) was reviewed under the OHT7’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.