CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup

K252118 · Hangzhou Clongene Biotech Co., Ltd. · NFT · Aug 27, 2025 · Clinical Toxicology

Device Facts

• Record ID: K252118
• Device Name: CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup
• Applicant: Hangzhou Clongene Biotech Co., Ltd.
• Product Code: NFT · Clinical Toxicology
• Decision Date: Aug 27, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

The CLUNGENE Multi-Drug Test Easy Cup is a lateral flow immunoassay for the qualitative detection of Morphine, Methamphetamine, Cocaine, Marijuana, Methylenedioxymethamphetamine, Buprenorphine, Propoxyphene, Amphetamine, Phencyclidine, EDDP (Methadone metabolite), Oxycodone, Oxazepam, Nortriptyline, Secobarbital, Methadone, 6-Monoacetylmorphine and Fentanyl in human urine at the following cut off concentrations: [Table of drugs and cut-offs]. The single or multi-test cups can consist of any combination of the above listed drug analytes, but only one cut off concentration under same drug condition will be included per device. This test provides only preliminary result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. Evaluate preliminary positive results carefully. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The CLUNGENE Multi-Drug Home Test Easy Cup is a lateral flow immunoassay for the qualitative detection of Morphine, Methamphetamine, Cocaine, Marijuana, Methylenedioxymethamphetamine, Buprenorphine, Propoxyphene, Amphetamine, Phencyclidine, EDDP (Methadone metabolite), Oxycodone, Oxazepam, Nortriptyline, Secobarbital, Methadone, 6-Monoacetylmorphine and Fentanyl in human urine at the following cut off concentrations: [Table of drugs and cut-offs]. The single or multi-test cup offers any combination from above 1 to 17 drugs, but only one cut off concentration under same drug condition will be included per device. The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC-MS/MS is the preferred confirmatory method. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.

Device Story

Device is lateral flow immunoassay cup for qualitative detection of drugs of abuse in human urine; uses competitive binding principle with monoclonal antibody conjugates; urine sample flows via capillary action across pre-coated membrane; drug presence below cutoff allows antibody binding to immobilized drug-protein conjugate (colored line = negative); drug presence at/above cutoff inhibits binding (no line = preliminary positive); control line confirms proper performance; used in home or clinical settings; operated by lay users or clinicians; provides preliminary results requiring confirmatory testing via GC/MS or LC/MS; aids in identifying potential substance use.

Clinical Evidence

Bench testing only. Performance validated via precision/reproducibility studies (25 days, 3 lots), analytical specificity/interference testing, and method comparison against LC-MS/MS (80 samples per drug). Lay-user study (n=280) confirmed ease of use and performance across various educational backgrounds. No clinical prospective/retrospective studies performed.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding; cup format; ready-to-use; desiccant included; stable at 4-30°C for 24 months; qualitative detection; no electronic components; no software.

Indications for Use

Indicated for qualitative detection of drugs of abuse (Morphine, Methamphetamine, Cocaine, Marijuana, MDMA, Buprenorphine, Propoxyphene, Amphetamine, Phencyclidine, EDDP, Oxycodone, Oxazepam, Nortriptyline, Secobarbital, Methadone, 6-MAM, Fentanyl) in human urine. Intended for OTC use as a preliminary screening test. 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 SUMMARY

510(k) Number: K252118

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.