510(k) · Cleared

Cleared

Cannabinoids Urine Test

K110182510(k) TraditionalCleared May 20, 2011119-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

Guangzhou Wondfo Biotech Co., Ltd. · LDJ Enzyme Immunoassay, Cannabinoids

Cleared on May 20, 2011 as substantially equivalent to K020771 (ACON Laboratories, Inc., 2002) after a 119-day review. Its family tree reaches back 1 generation to 2002.

Decided: May 20, 2011
Review: 119 days
Class: Class II
Product code: LDJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K020771 (2002). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK020771 Acon One Step Drug Screen Test CardACON Laboratories, Inc. · 2002
This deviceK110182 Cannabinoids Urine TestGuangzhou Wondfo Biotech Co., Ltd. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K020771	Acon One Step Drug Screen Test Card	ACON Laboratories, Inc.	2002	—
0 (this device)	K110182	Cannabinoids Urine Test	Guangzhou Wondfo Biotech Co., Ltd.	2011	—

FIG. 1 — Lineage of K110182, 2002–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K020771	Acon One Step Drug Screen Test Card Summary page 1 …LDJ 862.3870 The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: Acon Laboratories, Inc. One Step Drug Screen Test Card, K020771. Description of the device: test using a la…	ACON Laboratories, Inc.	2002	—

Also cleared against K020771: 8 other devices →

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?

Its one ancestor has no recall.
8 other devices also cite its predicate K020771.

How does its category compare?

All LDJ devices

LDJ Enzyme Immunoassay, Cannabinoids: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

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	—

What is it indicated for?

Wondfo Cannabinoids Urine Test is an immunochromatographic assay for the qualitative determination of Cannabinoids in human urine. The test is available in a cassette format and a strip format. The test has a cutoff of S0ng/mL of Cannabinolds. It Is intended for prescription use and over the counter use.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a conformed analytical result. GC/MS 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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K110182 · printed Nov 5, 2026

Cite this page

510(k) Report. “K110182: Cannabinoids Urine Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110182

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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