# K190412: CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Clongene Biotech Co., Ltd.
- Decided: Mar 21, 2019 after 28 days
- Product code: NGL (Test, Opiates, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K945610 (1995). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180349: AssureTech Panel Dip Tests, AssureTech Quick Cup Tests, Assure Tech. (Hangzhou) Co, Ltd. (2018) Summary page 5.

## 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, Phencyclidine, Methylenedioxymethamphetamine, Tricyclic Antidepressants, EDDP and Propoxyphene in human urine at the cutoff concentrations of: Drug Calibrator Cut-off Amphetamine d-Amphetamine 1000 ng/mL Secobarbital Secobarbital 300 ng/mL Oxazepam Oxazepam 300 ng/mL Cocaine Benzoylecgonine 300 ng/mL Methamphetamine d-Methamphetamine 1000 ng/mL Opiates Morphine 2000 ng/mL Methadone Methadone 300 ng/mL Oxycodone Oxycodone 100 ng/mL Marijuana 11-Nor-△9-Tetrahydrocannabinol-9 COOH 50 ng/mL Buprenorphine Buprenorphine 10 ng/mL Methylenedioxymethamphetamine D,L-Methylenedioxymethamphetamine 500 ng/mL Phencyclidine Phencyclidine 25 ng/mL Tricyclic Antidepressants Nortriptyline 1000 ng/mL EDDP (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine) 300 ng/mL Propoxyphene d-Propoxyphene 300 ng/mL 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 method 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. 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: Drug Calibrator Cut-off Amphetamine d-Amphetamine 1000 ng/mL Secobarbital Secobarbital 300 ng/mL Oxazepam Oxazepam 300 ng/mL Cocaine Benzoylecgonine 300 ng/mL Methamphetamine d-Methamphetamine 1000 ng/mL Opiates Morphine 2000 ng/mL Methadone Methadone 300 ng/mL Oxycodone Oxycodone 100 ng/mL Marijuana 11-Nor-△9-Tetrahydrocannabinol-9 COOH 50 ng/mL Buprenorphine Buprenorphine 10 ng/mL Methylenedioxymethamphetamine D,L-Methylenedioxymethamphetamine 500 ng/mL Phencyclidine Phencyclidine 25 ng/mL Tricyclic Antidepressants Nortriptyline 1000 ng/mL EDDP (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine) 300 ng/mL Propoxyphene d-Propoxyphene 300 ng/mL 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 method 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.

Source page: https://510kreport.com/device/K190412
Methodology: https://510kreport.com/methodology