CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
Device Facts
| Record ID | K181790 |
|---|---|
| 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 | Jul 26, 2018 |
| 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 Ampletamine, Oxazepam, Methamphetamine, Morphine, Oxycodone, Secobarbital, Methadone, Buprenorphine, Methylenedioxymethamphetamine and Tricyclic Antidepressants in human urine at the cutoff concentrations of: [Table of drugs 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 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 method 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, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Methadone, Buprenorphine, Phencyclidine, Methylenedioxymethamphetamine and Tricyclic Antidepressants in human urine at the cutoff concentrations of: [Table of drugs 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 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 method 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.
Device Story
Single-use lateral flow immunochromatographic assays for qualitative detection of drugs of abuse in human urine. Device formats include Dip Card and Easy Cup. Principle: competitive binding; urine sample migrates via capillary action; target drugs below cutoff do not saturate monoclonal antibody binding sites, allowing formation of visible colored test line; drugs above cutoff saturate binding sites, preventing test line formation. Control line forms to verify proper test performance. Used in home or point-of-care settings by lay users. Results are visual; positive results are preliminary and require confirmation via GC/MS or LC/MS. Provides rapid screening for clinical consideration.
Clinical Evidence
No clinical studies performed. Evidence consists of bench testing (precision, interference, specificity, stability) and a lay-user study. Lay-user study included 300 participants per device format (ages 18 to >50) using spiked urine samples confirmed by LC/MS. Results showed high concordance with expected values across all drug analytes and concentrations.
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding principle. Single-use device. Components: Dip Card or Easy Cup, package insert, urine collection cup. Sealed in aluminum pouch with desiccant. No electronic components or software.
Indications for Use
Indicated for qualitative, simultaneous detection of drugs of abuse (Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Methadone, Buprenorphine, Phencyclidine, MDMA, Tricyclic Antidepressants) in human urine. Intended for over-the-counter (OTC) use. Not intended to distinguish 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).
