CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup

K190412 · Hangzhou Clongene Biotech Co., Ltd. · NGL · Mar 21, 2019 · Clinical Toxicology

Device Facts

• Record ID: K190412
• Device Name: CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
• Applicant: Hangzhou Clongene Biotech Co., Ltd.
• Product Code: NGL · Clinical Toxicology
• Decision Date: Mar 21, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

CLUNGENE® Multi-Drug Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Opiates, Oxycodone, Secobarbital, Methadone, Buprenorphine, Methylenedioxymethamphetamine, Tricyclic Antidepressants, EDDP and Propoxyphene in human urine at the cutoff concentrations of: [Table of analytes and cutoffs]. Configuration of the CLUNGENE® Multi-Drug Test Dip Card can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Nortriptyline, 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 exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GCMS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only. CLUNGENE® Multi-Drug Test Easy Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Opiates, Oxycodone, Secobarbital, Methadone, Buprenorphine, Phencyclidine, Methylenedioxymethamphetamine, Tricyclic Antidepressants, EDDP and Propoxyphene in human urine at the cutoff concentrations of: [Table of analytes and cutoffs]. Configuration of the CLUNGENE® Multi-Drug Test Easy Cup can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Nortriptyline, 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 exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

Device Story

Lateral flow immunochromatographic assay for qualitative detection of drugs of abuse in human urine. Input: urine sample. Principle: competitive binding; target drugs in sample compete with immobilized drug-conjugate for limited antibody binding sites. Output: visible colored line in test region (negative result) or absence of line (positive result if drug exceeds cutoff). Used in point-of-care or home settings by lay users or professionals. Provides preliminary results; requires confirmatory testing (GC/MS or LC/MS). Benefits patient by enabling rapid, preliminary screening for drug presence.

Clinical Evidence

Bench testing only. Precision, interference, specificity, and method comparison studies performed using spiked urine samples confirmed by LC/MS. Lay-user study conducted with 310 participants per device format across diverse demographics (ages 18 to >50) showed high accuracy (90-100%) across various drug concentrations relative to cutoffs. No clinical studies required.

Technological Characteristics

Lateral flow immunochromatographic assay. Single-use dip card or cup format. Employs monoclonal mouse antibodies. Qualitative detection based on competitive binding. No external energy source required. Stable at 4-30°C. No software or connectivity.

Indications for Use

Indicated for qualitative, simultaneous detection of drugs of abuse (Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Opiates, Oxycodone, Secobarbital, Methadone, Buprenorphine, Phencyclidine, MDMA, Tricyclic Antidepressants, EDDP, Propoxyphene) in human urine. Intended for over-the-counter and prescription use. Not for distinguishing between prescription use and abuse.

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: k190412

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.