Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro

K250067 · Guangzhou Decheng Biotechnology Co., Ltd. · NGL · Feb 20, 2025 · Clinical Toxicology

Device Facts

• Record ID: K250067
• Device Name: Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro
• Applicant: Guangzhou Decheng Biotechnology Co., Ltd.
• Product Code: NGL · Clinical Toxicology
• Decision Date: Feb 20, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

Dochek® Multi-Drug Urine Test Cup Pro is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations. [Table of drugs and cutoffs omitted for brevity]. Dochek® Multi-Drug Urine Test Cup Pro offers any combinations from 1 to 17 drugs but only one cutoff concentration under same drug condition will be included per device. For in vitro diagnostic use only. The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method. Dochek® Multi-Drug Urine Test Cup is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations. [Table of drugs and cutoffs omitted for brevity]. Dochek® Multi-Drug Urine Test Cup offers any combinations from 1 to 17 drugs but only one cutoff concentration under same drug condition will be included per device. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only. The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method.

Device Story

Lateral flow immunochromatographic assay for qualitative drug detection in human urine. Device consists of integrated test strips within a plastic cup. User collects urine directly into cup; capillary action draws sample across pre-coated membrane. Competitive binding principle: drug in sample competes with drug-protein conjugate for limited antibody binding sites. Absence of colored line in test region indicates positive result; presence of line indicates negative result. Control line confirms proper procedure. Used in clinical or home settings; operated by professionals or lay users. Provides preliminary results requiring confirmation via GC/MS or LC/MS. Facilitates rapid screening for drugs of abuse, aiding clinical decision-making.

Clinical Evidence

No clinical studies performed. Evidence includes bench testing: precision/reproducibility (25 days, 3 lots), analytical specificity/cross-reactivity, interference testing (pH 4-9, specific gravity 1.035), and method comparison against LC-MS/MS (80 samples per drug). Lay-user study (n=280) confirmed ease of use and performance across diverse demographics.

Technological Characteristics

Lateral flow immunochromatographic assay. Competitive binding principle. Integrated test strips in plastic cup. Ready-to-use format. No electronic components. Stable at 2-30°C for 36 months.

Indications for Use

Indicated for qualitative detection of single or multiple drugs of abuse in human urine. Intended for OTC (Dochek Cup) or professional (Dochek Cup Pro) use. Target population includes individuals requiring drug screening. Contraindications: None stated; not for definitive diagnosis.

Regulatory Classification

Identification

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An opiate 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 SUMMARY

510(k) Number: k250067

This 510(k) was reviewed under the OHT7/OHT8 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.