510(k) · Cleared

Cleared

Urine Cannabinoids (THC) Screen Flex Reagent Cartridge, Catalog NO. DF 95A

K000461510(k) TraditionalCleared Apr 6, 200055-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

Dade Behring, Inc. · LDJ Enzyme Immunoassay, Cannabinoids

Cleared on Apr 6, 2000 after a 55-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided: Apr 6, 2000
Review: 55 days
Class: Class II
Product code: LDJ
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK000461 Urine Cannabinoids (THC) Screen Flex Reagent Cartridge, Catalog NO.…Dade Behring, Inc. · 2000
Descendant · cites it directly · 1 of its ownK062128 The Dimension Vista Flex Reagent Cartridges / Kit AssaysDade Behring, Inc. · 2006
Descendant · 2 generations on · 0 of its ownK102045 Dimension Visa HBA1C, Model K3105ASiemens Heatlhcare Diagnostics, Inc. · 2011 · Recalled

Most influential descendants

Showing 2 of 2 · See all

K062128The Dimension Vista Flex Reagent Cartridges / Kit AssaysDade Behring, Inc. · 2006 · cites it directly1descendant
K102045Dimension Visa HBA1C, Model K3105ASiemens Heatlhcare Diagnostics, Inc. · 2011 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K000461	Urine Cannabinoids (THC) Screen Flex Reagent Cartridge, Catalog NO. DF 95A	Dade Behring, Inc.	2000	—
+1	K062128	The Dimension Vista Flex Reagent Cartridges / Kit Assays	Dade Behring, Inc.	2006	—
+2	K102045	Dimension Visa HBA1C, Model K3105A	Siemens Heatlhcare Diagnostics, Inc.	2011	3

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2011	1	0

FIG. 1 — Lineage of K000461, 2000–2011Source: 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

Get a 510(k) Report

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? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K062128	The Dimension Vista Flex Reagent Cartridges / Kit Assays	Dade Behring, Inc.	2006	1

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, K062128 (Dade Behring, Inc., 2006) has gone furthest, with 1 descendant 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/K000461 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000461: Urine Cannabinoids (THC) Screen Flex Reagent Cartridge, Catalog NO. DF 95A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000461

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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