510(k) · Cleared

Cleared

Nano-Check Dat 5 Multi Drug Screening Test for Cannabinoids, Opiates, Cocaine, Methamphetamine & Phencyclidine

K050594510(k) TraditionalCleared May 15, 200568-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

Nano-Ditech Co. · LDJ Enzyme Immunoassay, Cannabinoids

Cleared on May 15, 2005 as substantially equivalent to K003557 (ACON Laboratories, Inc., 2001) and 4 other predicates after a 68-day review. Its family tree reaches back 2 generations to 1996.

Decided: May 15, 2005
Review: 68 days
Class: Class II
Product code: LDJ
Recalls: None
Predicates: 5

Its longest line of descent runs back 2 generations to K961249 (1996). 7 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK961249 Accusign Met/Biosign MetPrinceton BioMeditech Corp. · 1996
1 generation backK011672 Acon Mamp One Step Methamphetamine Test Strip, Acon Mamp One Step…ACON Laboratories, Inc. · 2001
This deviceK050594 Nano-Check Dat 5 Multi Drug Screening Test for Cannabinoids…Nano-Ditech Co. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K961249	Accusign Met/Biosign Met	Princeton BioMeditech Corp.	1996	—
−1	K011672	Acon Mamp One Step Methamphetamine Test Strip, Acon Mamp One Step…	ACON Laboratories, Inc.	2001	—
0 (this device)	K050594	Nano-Check Dat 5 Multi Drug Screening Test for Cannabinoids, Opiates, Cocaine…	Nano-Ditech Co.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
2001	3	0
2004	1	0

FIG. 1 — Lineage of K050594, 1996–2005Source: 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? (5)

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
*	K003557	Acon THC One Step Marijuana Test Strip (Urine);Acon THC One Step Marijuana Test Device… Summary page 1 …i Panel Drug of Abuse Test 3. Predicate Device Information: 1. ACON THC One Step Marijuana Test Strip, ACON Laboratories, Inc., San Diego, CA, K003557 2. ACON OPI One Step Opiates Test Strip, ACON Laboratories, Inc., San Diego, CA, K040274 3. ACON COC One Ste…	ACON Laboratories, Inc.	2001	—
*	K040274	Acon Opi One Step Opiate Test Strip and Acon Opi One Step Opiate Test Device Summary page 1 …arijuana Test Strip, ACON Laboratories, Inc., San Diego, CA, K003557 2. ACON OPI One Step Opiates Test Strip, ACON Laboratories, Inc., San Diego, CA, K040274 3. ACON COC One Step Cocaine Test Strip, ACON Laboratories, Inc., San Diego, CA, K010841…	ACON Laboratories, Inc.	2004	—
*	K010841	Acon Coc One Step Cocaine Test Strip, Acon Coc One Step Cocaine Test Device Summary page 1 …Opiates Test Strip, ACON Laboratories, Inc., San Diego, CA, K040274 3. ACON COC One Step Cocaine Test Strip, ACON Laboratories, Inc., San Diego, CA, K010841 Page I of4 4. ACON mAMP One Step…	ACON Laboratories, Inc.	2001	—
*	K011672	Acon Mamp One Step Methamphetamine Test Strip, Acon Mamp One Step Methamphetamine Test… Summary page 2 …Page I of4 4. ACON mAMP One Step Methamphetamine Test Strip, ACON Laboratories, Inc., San Diego, CA, K011672 5. ACON PCP One Step Phencyclidine Test Strip, ACON Laboratories, Inc., San Diego, CA, K011730 4. Device Description…	ACON Laboratories, Inc.	2001	—
*	K011730	Acon PCP One-Step Phencyclidine Test Strip, Acon PCP One-Step Phencyclidine Test Device Summary page 2 …etamine Test Strip, ACON Laboratories, Inc., San Diego, CA, K011672 5. ACON PCP One Step Phencyclidine Test Strip, ACON Laboratories, Inc., San Diego, CA, K011730 4. Device Description: The Nano-CheckTM DAT 5M test is a one step, type II,competitive immuochromatographic assay fo…	ACON Laboratories, Inc.	2001	—

Also cleared against K003557: 5 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?

The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
None of the 7 ancestors has a recall.
5 other devices also cite its predicate K003557.

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	—

What is it indicated for?

The Nano-CheckTM DAT 5 Multi Drug Screening Test for Marijuana, Opiates, Cocaine, Methamphetamine and Phencyclidine is a rapid, self-controlled immunoassay for the qualitative detection of Cannabinoids (THC), Opiates (OPI), Benzoylecgonine (COC), Methamphetamine (mAMP) and Phencyclidine (PCP) compounds and their metabolites in human urine. The detection limits (cut-off concentrations) of this test are as follows: Cannabinoids at 50 ng/ml, Opiates at 2000 ng/ml, Cocaine at 300 ng/ml, Methamphetamine at 1000 ng/ml and Phencyclidine at 25 ng/ml. This assay is intended for Professional and Laboratory In-Vitro Use Only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050594 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050594: Nano-Check Dat 5 Multi Drug Screening Test for Cannabinoids, Opiates, Cocaine, Methamphetamine & Phencyclidine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050594

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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