510(k) · Cleared

Cleared

Acon THC One Step Marijuana Test Strip (Urine);Acon THC One Step Marijuana Test Device (Urine)

K003557510(k) TraditionalCleared Mar 15, 2001118-day reviewClass II21 CFR 862.3870

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

ACON Laboratories, Inc. · LDJ Enzyme Immunoassay, Cannabinoids

Cleared on Mar 15, 2001 after a 118-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 94 later devices descend from it.

Decided: Mar 15, 2001
Review: 118 days
Class: Class II
Product code: LDJ
Recalls: None
Predicates: 0

94 later devices descend from it, 6 citing it directly.

This deviceK003557 Acon THC One Step Marijuana Test Strip (Urine);Acon THC One Step…ACON Laboratories, Inc. · 2001
Descendant · cites it directly · 88 of its ownK020313 Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step…Acon Laboratories Co. · 2002
Descendant · 2 generations on · 83 of its ownK031759 Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon…ACON Laboratories, Inc. · 2003 · Recalled
Descendant · 3 generations on · 80 of its ownK061718 Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · Recalled
Descendant · 4 generations on · 55 of its ownK122809 Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013
Descendant · 5 generations on · 16 of its ownK140748 One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test…Co-Innovation Biotech Co., Ltd. · 2014

Showing 5 of 94 descendants. See all descendants

Descendants cleared per year

2002high 9 (2015) · low 0 (2007)2026

Most influential descendants

Showing 5 of 94 · See all

K020313Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug…Acon Laboratories Co. · 2002 · cites it directly88descendants
K031759Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum Multi-Drug…ACON Laboratories, Inc. · 2003 · 2 generations on83descendants
K061718Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · 3 generations on80descendants
K122809Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013 · 4 generations on55descendants
K140748One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test DipcardCo-Innovation Biotech Co., Ltd. · 2014 · 5 generations on16descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003557	Acon THC One Step Marijuana Test Strip (Urine);Acon THC One Step Marijuana…	ACON Laboratories, Inc.	2001	—
+1	K020313	Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug…	Acon Laboratories Co.	2002	—
+2	K031759	Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum…	ACON Laboratories, Inc.	2003	1
+3	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	—
+5	K140748	One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test Dipcard	Co-Innovation Biotech Co., Ltd.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2004	3	0
2005	4	0
2006	2	0
2009	1	0
2011	1	0
2012	1	0
2013	4	0
2014	4	0
2015	9	0
2016	9	0
2017	2	0
2018	9	0
2019	6	0
2020	4	0
2021	3	0
2022	3	0
2023	7	0
2024	9	0
2025	7	0
2026	4	0

FIG. 1 — Lineage of K003557, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (94)

See all 94

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K020313	Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug…	Acon Laboratories Co.	2002	88
K041685	Acon Multi-Clin Drug Screen Test Device	ACON Laboratories, Inc.	2004	1
K121065	Polymed Therapeutics Fastep Dipstick Drugs of Abuse Screen Device and Dipcard Drugs of…	Polymed Therapeutics, Inc.	2013	0
K050936	ON Call Home Drug Test for Marijuana and on Call Home Drug Test for Marijuana and Cocaine	ACON Laboratories, Inc.	2005	0
K050594	Nano-Check Dat 5 Multi Drug Screening Test for Cannabinoids, Opiates, Cocaine…	Nano-Ditech Co.	2005	0
K041743	Acon Tri-Fect Drug Screen Test Device	ACON Laboratories, Inc.	2004	0

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?

Of its descendants, K020313 (Acon Laboratories Co., 2002) has gone furthest, with 88 descendants of its own.

How does its category compare?

All LDJ devices

LDJ Enzyme Immunoassay, Cannabinoids: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LDJ

2in 2024

2007high 4 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LDJ

48in 2015

2007high 219 (2011) · low 48 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LDJ

1in 2023

2007high 4 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LDJ

1in 2015

2007high 1 (2015) · low 0 (2007)2025

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	—

https://510kreport.com/device/K003557 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003557: Acon THC One Step Marijuana Test Strip (Urine);Acon THC One Step Marijuana Test Device (Urine).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003557

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026