510(k) · Cleared
ClearedCLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou Clongene Biotech Co., Ltd. · LDJ Enzyme Immunoassay, Cannabinoids
Cleared on Mar 18, 2016 as substantially equivalent to K052115 (First Check Diagnostics, LLC, 2005) after an 81-day review. Its family tree reaches back 2 generations to 2005.
- Decided
- Mar 18, 2016
- Review
- 81 days
- Class
- Class II
- Product code
- LDJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K050186 (2005). No later device cites it as a predicate yet.
- Root · 2 generations backK050186 Ameditech Immutest Multi-Drug Screen Panel IiiAmeditech, Inc. · 2005 · Recalled
- 1 generation backK052115 First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc)…First Check Diagnostics, LLC · 2005 · Recalled
- This deviceK153741 CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE…Hangzhou Clongene Biotech Co., Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K050186 | Ameditech Immutest Multi-Drug Screen Panel Iii | Ameditech, Inc. | 2005 | 3 |
| −1 | K052115 | First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc), Amphetamine… | First Check Diagnostics, LLC | 2005 | 86 |
| 0 (this device) | K153741 | CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test | Hangzhou Clongene Biotech Co., Ltd. | 2016 | — |
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 LDJ? 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 LDJ device
- #1 K232732 Rapid Marijuana (THC) Test Strip 20, Rapid…score 9.4 · 10 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 |
|---|---|---|---|
| * | K052115 | First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc), Amphetamine (Amp)…Summary page 5…21 CFR, 862.3870 Cannabinoid Test System Toxicology DJG 21 CFR, 862.3650 Opiate Test System Toxicology 5. Predicate Devices: K052115 The FIRST CHECK MULTI DRUG CUP Urine Test 6. Intended Use Clungene Methamphetamine Tests are immunochromatographic assays… | 2005 |
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 11 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
- 2 of the 2 ancestors have a recall of any class.
- 12 other devices also cite its predicate K052115.
How does its category compare?
All LDJ devicesLDJ Enzyme Immunoassay, Cannabinoids: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · LDJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LDJ
48in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LDJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LDJ
1in 2015
MAUDE reports naming product code LDJ, 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 | 2 | — | 4 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 4 | 219 | 0 | 0 |
| 2012 | 4 | 193 | 0 | 0 |
| 2013 | 3 | 162 | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 48 | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 1 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Clungene Methamphetamine Tests are immunochromatographic assays for the qualitative determination of d-methamphetamine in human urine at cut-off concentration of 1000 ng/mL. The calibrator is d-methamphetamine. The tests are available in a Cassette format, a Easy Cup format, a Split Key Cup format and a Dip Card format. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed…
Read the full statement (486 words)
Clungene Methamphetamine Tests are immunochromatographic assays for the qualitative determination of d-methamphetamine in human urine at cut-off concentration of 1000 ng/mL. The calibrator is d-methamphetamine. The tests are available in a Cassette format, a Easy Cup format, a Split Key Cup format and a Dip Card format.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.
For in vitro diagnostic use only.
Clungene Marijuana Tests are immunochromatographic assays for the qualitative determination of 11-Nor-△9-Tetrahydrocannabinol-9-COOH in human urine at cut-off concentration of 50 ng/mL. The calibrator is 11-Nor-△9-Tetrahydrocannabinol-9-COOH. The tests are available in a Cassette format, a Easy Cup format, a Split Key Cup format and a Dip Card format.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.
For in vitro diagnostic use only.
Clungene Morphine Tests are immunochromatographic assays for the qualitative determination of Morphine in human urine at cut-off concentration of 300 ng/mL. The calibrator is Morphine. The tests are available in a Cassette format, a Easy Cup format, a Split Key Cup format and a Dip Card format.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.
For in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153741 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153741: CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153741
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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