Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx

K202567 · Guangzhou Wondfo Biotech Co., Ltd. · NFT · Sep 25, 2020 · Clinical Toxicology

Device Facts

• Record ID: K202567
• Device Name: Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx
• Applicant: Guangzhou Wondfo Biotech Co., Ltd.
• Product Code: NFT · Clinical Toxicology
• Decision Date: Sep 25, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

Wondfo T-Dip® Multi-Drug Urine Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, 2- ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedoxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of: [Table of drugs and cutoffs]. Wondfo T-Dip® Multi-Drug Urine Test Panel 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, 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.

Device Story

The Wondfo T-Dip® Multi-Drug Urine Test Panel is a rapid, single-use, lateral flow immunochromatographic assay for qualitative drug detection in human urine. The device uses competitive binding; target drugs in the urine sample compete with immobilized drug-conjugates for binding sites on monoclonal antibody-coated particles. If the drug concentration is below the cutoff, a colored band forms at the test line; if above, the binding sites are saturated, and no band forms. A control line confirms proper test performance. The device is used in point-of-care or home settings by lay users or professionals. Results are visual and preliminary; positive results require confirmation via GC/MS or LC/MS. The device aids in identifying potential drug use, though it does not differentiate between prescribed use and abuse.

Clinical Evidence

No clinical studies were performed. Evidence consists of analytical performance (precision, specificity, interference, stability) and method comparison studies. Method comparison against GC/MS or LC/MS was conducted with 80 samples per drug. A lay-user study with 280 participants confirmed the device is easy to use and accurate across various drug concentrations.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Single-use test panel format. Materials include test strips, desiccants, and plastic housing. No electronic components or software. Stability: 4-30°C for 24 months.

Indications for Use

Indicated for qualitative, simultaneous detection of 15 drugs of abuse (Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, EDDP, Methamphetamine, MDMA, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Cannabinoids) in human urine. Intended for OTC or prescription use. Not for distinguishing between prescription use and abuse.

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)

{0}

1

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

510(k) Number: k202567

This 510(k) was reviewed under OIR’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.