510(k) · Cleared
ClearedRapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Co-Innovation Biotech Co., Ltd. · LDJ Enzyme Immunoassay, Cannabinoids
Cleared on Jan 17, 2024 as substantially equivalent to K192515 (Shenzhen Bioeasy Biotechnology Co., Ltd., 2019) after a 132-day review. Its family tree reaches back 10 generations to 1995.
- Decided
- Jan 17, 2024
- Review
- 132 days
- Class
- Class II
- Product code
- LDJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K945610 (1995). 32 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 6 generations between
- 3 generations backK153050 Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardCo-Innovation Biotech Co., Ltd. · 2016
- 2 generations backK182530 BIOEASY Multi-Drug Test CupShenzhen Bioeasy Biotechnology Co., Ltd. · 2018
- 1 generation backK192515 BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card…Shenzhen Bioeasy Biotechnology Co., Ltd. · 2019
- This deviceK232732 Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test…Co-Innovation Biotech Co., Ltd. · 2024
Show all 10 generations
- Root · 10 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 9 generations backK011673 Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step…ACON Laboratories, Inc. · 2001
- 8 generations backK020313 Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step…Acon Laboratories Co. · 2002
- 7 generations backK031759 Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon…ACON Laboratories, Inc. · 2003 · Recalled
- 6 generations backK061718 Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · Recalled
- 5 generations backK122809 Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013
- 4 generations backK140748 One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test…Co-Innovation Biotech Co., Ltd. · 2014
- 3 generations backK153050 Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardCo-Innovation Biotech Co., Ltd. · 2016
- 2 generations backK182530 BIOEASY Multi-Drug Test CupShenzhen Bioeasy Biotechnology Co., Ltd. · 2018
- 1 generation backK192515 BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card…Shenzhen Bioeasy Biotechnology Co., Ltd. · 2019
- This deviceK232732 Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test…Co-Innovation Biotech Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K945610 | Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-Amp | Princeton BioMeditech Corp. | 1995 | — |
| −9 | K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test… | ACON Laboratories, Inc. | 2001 | — |
| −8 | K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug… | Acon Laboratories Co. | 2002 | — |
| −7 | K031759 | Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum… | ACON Laboratories, Inc. | 2003 | 1 |
| −6 | K061718 | Innovacon Spectrum II Test Card | Innovacon, Inc. | 2006 | 6 |
| −5 | K122809 | Advin Multi-Drug Screen Test Cassette, Dip Card and Cup | Advin Biotech | 2013 | — |
| −4 | K140748 | One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test Dipcard | Co-Innovation Biotech Co., Ltd. | 2014 | — |
| −3 | K153050 | Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard | Co-Innovation Biotech Co., Ltd. | 2016 | — |
| −2 | K182530 | BIOEASY Multi-Drug Test Cup | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2018 | — |
| −1 | K192515 | BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20… | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2019 | — |
| 0 (this device) | K232732 | Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20… | Co-Innovation Biotech Co., Ltd. | 2024 | — |
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 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 K223162 Healgen® Accurate Oral Fluid Drug Test…score 8.9 · 4 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K192515 | BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY…Summary page 5…THC) Test Dipcard 50 4. The Predicate Devices 5-1 Co-Innovation Biotech Co.,Ltd. K192515 BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Tes… | 2019 |
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 29 years and passes through 7 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 32 ancestors have a recall of any class.
How does its category compare?
All LDJ devicesLDJ Enzyme Immunoassay, Cannabinoids: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Rapid Marijuana (THC) Test Strip 20 and Rapid Marijuana (THC) Test Dipcard 20 is a rapid, screening test for the qualitative detection of Marijuana and their metabolites in human urine at the cut-off concentration of 20 ng/mL. Rapid Marijuana (THC) Test Strip 50 and Rapid Marijuana (THC) Test Dipcard 50 is a rapid, screening test for the qualitative detection of Marijuana and their metabolites in human urine at the cut-off concentration of 50 ng/mL. The…
Read the full statement (158 words)
Rapid Marijuana (THC) Test Strip 20 and Rapid Marijuana (THC) Test Dipcard 20 is a rapid, screening test for the qualitative detection of Marijuana and their metabolites in human urine at the cut-off concentration of 20 ng/mL.
Rapid Marijuana (THC) Test Strip 50 and Rapid Marijuana (THC) Test Dipcard 50 is a rapid, screening test for the qualitative detection of Marijuana and their metabolites in human urine at the cut-off concentration of 50 ng/mL.
The tests contain two formats:1) Test Strip and 2) Test Dipcard. The tests are intended for in vitro diagnostics use. They are intended for over-the-counter use.
The tests provide only a preliminary result. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. Gas Chromatography/Mass spectrometry (GC/MS) or Liquid chromatography/Mass spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232732 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232732: Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232732
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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