510(k) · Cleared
ClearedCLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou Clongene Biotech Co., Ltd. · NFT Test, Amphetamine, Over The Counter
Cleared on Aug 27, 2025 as substantially equivalent to K250727 (Hangzhou AllTest Biotech Co., Ltd., 2025) after a 51-day review. Its family tree reaches back 11 generations to 2000.
- Decided
- Aug 27, 2025
- Review
- 51 days
- Class
- Class II
- Product code
- NFT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K001178 (2000). 21 ancestors in all, the oldest K971218 (1997). No later device cites it as a predicate yet.
- Root · 11 generations backK001178 Cedia Dau 6-Acetylmorphine AssayMicrogenics Corp. · 2000
- 7 generations between
- 3 generations backK233019 AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test…Hangzhou AllTest Biotech Co., Ltd. · 2023
- 2 generations backK244043 AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd. · 2025
- 1 generation backK250727 AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine…Hangzhou AllTest Biotech Co., Ltd. · 2025
- This deviceK252118 CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test…Hangzhou Clongene Biotech Co., Ltd. · 2025
Show all 11 generations
- Root · 11 generations backK001178 Cedia Dau 6-Acetylmorphine AssayMicrogenics Corp. · 2000
- 10 generations backK040316 Cedia Buprenorphine AssayMicrogenics Corp. · 2004
- 9 generations backK042988 Rapid One Step Buprenorphine Test CardTianjin New Bay Bioresearch Co., Ltd. · 2005
- 8 generations backK060527 Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine…Alfa Scientific Designs, Inc. · 2006
- 7 generations backK063545 Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine…Alfa Scientific Designs, Inc. · 2007
- 6 generations backK152122 Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View…Alfa Scientific Designs, Inc. · 2016
- 5 generations backK173303 INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC…Alfa Scientific Designs, Inc. · 2018
- 4 generations backK182738 Single and Multi-Drug Rapid Test Panel With Adulteration (Urine)…Hangzhou AllTest Biotech Co., Ltd. · 2019
- 3 generations backK233019 AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test…Hangzhou AllTest Biotech Co., Ltd. · 2023
- 2 generations backK244043 AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd. · 2025
- 1 generation backK250727 AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine…Hangzhou AllTest Biotech Co., Ltd. · 2025
- This deviceK252118 CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test…Hangzhou Clongene Biotech Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K001178 | Cedia Dau 6-Acetylmorphine Assay | Microgenics Corp. | 2000 | — |
| −10 | K040316 | Cedia Buprenorphine Assay | Microgenics Corp. | 2004 | — |
| −9 | K042988 | Rapid One Step Buprenorphine Test Card | Tianjin New Bay Bioresearch Co., Ltd. | 2005 | — |
| −8 | K060527 | Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine Test… | Alfa Scientific Designs, Inc. | 2006 | — |
| −7 | K063545 | Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test… | Alfa Scientific Designs, Inc. | 2007 | — |
| −6 | K152122 | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug… | Alfa Scientific Designs, Inc. | 2016 | — |
| −5 | K173303 | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)… | Alfa Scientific Designs, Inc. | 2018 | — |
| −4 | K182738 | Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and… | Hangzhou AllTest Biotech Co., Ltd. | 2019 | — |
| −3 | K233019 | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel… | Hangzhou AllTest Biotech Co., Ltd. | 2023 | — |
| −2 | K244043 | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 2025 | — |
| −1 | K250727 | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 2025 | — |
| 0 (this device) | K252118 | CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup | Hangzhou Clongene Biotech Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NFT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NFT device
- #1 K244043 AllTest Multi-Drug Rapid Test Cup ; AllTest…score 20.3 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K250727 | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test CupSummary page 7…862.3870, Cannabinoids Test System Toxicology Cannabinoids (THC) 6. Predicate Devices: AllTest Multi-Drug Urine Test Cup (K250727) 7. Intended Use The CLUNGENE Multi-Drug Test Easy Cup is a lateral flow immunoassay for the qualitative… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- None of the 21 ancestors has a recall.
How does its category compare?
All NFT devicesNFT Test, Amphetamine, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · NFT
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NFT
37in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NFT
No recall names NFT since 2007.
Adverse event reports per year · NFT
No MAUDE report names NFT since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 6 | 56 | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 3 | 63 | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 4 | 31 | 0 | 0 |
| 2025 | 8 | 37 | 0 | 0 |
| 2026 | 5 | 35 | 0 | — |
What is it indicated for?
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…
Read the full statement (403 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252118 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252118: CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252118
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026