# K252118: CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Clongene Biotech Co., Ltd.
- Decided: Aug 27, 2025 after 51 days
- Product code: NFT (Test, Amphetamine, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K001178 (2000). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250727: AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup, Hangzhou AllTest Biotech Co., Ltd. (2025) Summary page 7.

## 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: Drug Calibrator Cut-off (ng/mL) Morphine (MOP/OPI300) Morphine 300 Morphine (MOP/OPI2000) Morphine 2,000 Methamphetamine (mAMP/MET1000) D-Methamphetamine 1,000 Methamphetamine (mAMP/MET500) D-Methamphetamine 500 Cocaine (COC300) Benzoylecgonine 300 Cocaine (COC150) Benzoylecgonine 150 Marijuana (THC) 11-nor-9-THC-9-COOH 50 Methylenedioxymethamphetamine (MDMA) D,L-Methylenedioxymethamphetamine 500 Buprenorphine (BUP) Buprenorphine 10 Propoxyphene (PPX) D-Propoxyphene 300 Amphetamine (AMP1000) D-Amphetamine 1,000 Amphetamine (AMP500) D-Amphetamine 500 Phencyclidine (PCP) Phencyclidine 25 Methadone metabolite (EDDP) 2-Ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine 300 Oxycodone (OXY) Oxycodone 100 Oxazepam (BZO) Oxazepam 300 Nortriptyline (TCA) Nortriptyline 1,000 Secobarbital (BAR) Secobarbital 300 Methadone (MTD) Methadone 300 6-Monoacetylmorphine (6-MAM) 6-Monoacetylmorphine 10 Fentanyl (FYL) Fentanyl 1 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: Drug (Identifier) Cut-off (ng/mL) Morphine (MOP/OPI2000) 300 or 2000 Methamphetamine (mAMP/MET) 500 or 1,000 Cocaine (COC) 150 or 300 Marijuana (THC) 50 Methylenedioxymethamphetamine (MDMA) 500 Buprenorphine (BUP) 10 Propoxyphene (PPX) 300 Amphetamine (AMP) 500 or 1,000 Phencyclidine (PCP) 25 Methadone metabolite (EDDP) 300 Oxycodone (OXY) 100 Oxazepam (BZO) 300 Nortriptyline (TCA) 1,000 Secobarbital (BAR) 300 Methadone (MTD) 300 6-Monoacetylmorphine (6-MAM) 10 Fentanyl (FYL) 1 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.

Source page: https://510kreport.com/device/K252118
Methodology: https://510kreport.com/methodology