510(k) · Cleared
ClearedCLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug 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. · NGL Test, Opiates, Over The Counter
Cleared on Mar 21, 2019 as substantially equivalent to K180349 (Assure Tech. (Hangzhou) Co, Ltd., 2018) after a 28-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Mar 21, 2019
- Review
- 28 days
- Class
- Class II
- Product code
- NGL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K945610 (1995). 31 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 5 generations between
- 3 generations backK140748 One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test…Co-Innovation Biotech Co., Ltd. · 2014
- 2 generations backK153050 Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardCo-Innovation Biotech Co., Ltd. · 2016
- 1 generation backK180349 AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd. · 2018
- This deviceK190412 CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupHangzhou Clongene Biotech Co., Ltd. · 2019
Show all 9 generations
- Root · 9 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 8 generations backK011673 Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step…ACON Laboratories, Inc. · 2001
- 7 generations backK020313 Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step…Acon Laboratories Co. · 2002
- 6 generations backK031759 Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon…ACON Laboratories, Inc. · 2003 · Recalled
- 5 generations backK061718 Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · Recalled
- 4 generations backK122809 Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013
- 3 generations backK140748 One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test…Co-Innovation Biotech Co., Ltd. · 2014
- 2 generations backK153050 Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardCo-Innovation Biotech Co., Ltd. · 2016
- 1 generation backK180349 AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd. · 2018
- This deviceK190412 CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupHangzhou Clongene Biotech Co., Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K945610 | Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-Amp | Princeton BioMeditech Corp. | 1995 | — |
| −8 | K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test… | ACON Laboratories, Inc. | 2001 | — |
| −7 | K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug… | Acon Laboratories Co. | 2002 | — |
| −6 | K031759 | Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum… | ACON Laboratories, Inc. | 2003 | 1 |
| −5 | K061718 | Innovacon Spectrum II Test Card | Innovacon, Inc. | 2006 | 6 |
| −4 | K122809 | Advin Multi-Drug Screen Test Cassette, Dip Card and Cup | Advin Biotech | 2013 | — |
| −3 | K140748 | One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test Dipcard | Co-Innovation Biotech Co., Ltd. | 2014 | — |
| −2 | K153050 | Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard | Co-Innovation Biotech Co., Ltd. | 2016 | — |
| −1 | K180349 | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests | Assure Tech. (Hangzhou) Co, Ltd. | 2018 | — |
| 0 (this device) | K190412 | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup | Hangzhou Clongene Biotech Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2014 | 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 NGL? 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 NGL device
- #1 K233417 AllTest Fentanyl Urine Test Cassettescore 32.0 · 7 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 |
|---|---|---|---|
| * | K180349 | AssureTech Panel Dip Tests, AssureTech Quick Cup TestsSummary page 5…CFR, 862.3700 Propoxyphene Test Toxicology Propoxyphene System (91) 5. Predicate Devices: K180349 The Assure Tech Panel Dip Tests/AssureTech Quick Cup Tests 6. Intended Use CLUNGENE® Multi-Drug Test Dip Card is… | 2018 |
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 24 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 31 ancestors have a recall of any class.
How does its category compare?
All NGL devicesNGL Test, Opiates, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · NGL
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NGL
39in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NGL
No recall names NGL since 2007.
Adverse event reports per year · NGL
1in 2024
MAUDE reports naming product code NGL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 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 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 13 | 40 | 0 | 1 |
| 2025 | 4 | 39 | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (450 words)
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.
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/K190412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190412: CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug 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/K190412
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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