510(k) · Cleared

Cleared

Opiate Enzyme Immunoassay, Catalog # 0020 (500 Tests Kit); Catalog # 0021 (5000 Tests Kit)

K020368510(k) TraditionalCleared Jun 4, 2002120-day reviewClass II21 CFR 862.3650

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

Lin-Zhi International, Inc. · DJG Enzyme Immunoassay, Opiates

Cleared on Jun 4, 2002 as substantially equivalent to K011150 (Microgenics Corp., 2001) after a 120-day review. Its family tree reaches back 1 generation to 2001. 6 later devices descend from it.

Decided: Jun 4, 2002
Review: 120 days
Class: Class II
Product code: DJG
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011150 (2001). 6 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK011150 Dridau Opiate AssayMicrogenics Corp. · 2001
This deviceK020368 Opiate Enzyme Immunoassay, Catalog # 0020 (500 Tests Kit); Catalog #…Lin-Zhi International, Inc. · 2002
Descendant · cites it directly · 2 of its ownK120761 Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000…Lin-Zhi International, Inc. · 2012
Descendant · 2 generations on · 1 of its ownK141803 Immunalysis Tramadol Urine Enzyme ImmunoassayImmunalysis Corporation · 2015
Descendant · cites it directly · 1 of its ownK110298 Opiate Enzyme ImmunoassayLin-Zhi International, Inc. · 2011
Descendant · 3 generations on · 0 of its ownK203527 Immunalysis Tapentadol Urine HEIALmmunalysis Corporation · 2022
Descendant · 2 generations on · 0 of its ownK172416 Synermed Opiate Enzyme ImmunoassayInfrared Laboratory Systems, LLC (Dba Synermed) · 2018

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2004high 1 (2004) · low 0 (2005)2026

Most influential descendants

Showing 5 of 6 · See all

K120761Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000 Calibrators, Lzi Opiate…Lin-Zhi International, Inc. · 2012 · cites it directly2descendants
K141803Immunalysis Tramadol Urine Enzyme ImmunoassayImmunalysis Corporation · 2015 · 2 generations on1descendant
K110298Opiate Enzyme ImmunoassayLin-Zhi International, Inc. · 2011 · cites it directly1descendant
K203527Immunalysis Tapentadol Urine HEIALmmunalysis Corporation · 2022 · 3 generations on0descendants
K172416Synermed Opiate Enzyme ImmunoassayInfrared Laboratory Systems, LLC (Dba Synermed) · 2018 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011150	Dridau Opiate Assay	Microgenics Corp.	2001	—
0 (this device)	K020368	Opiate Enzyme Immunoassay, Catalog # 0020 (500 Tests Kit); Catalog # 0021…	Lin-Zhi International, Inc.	2002	—
+1	K120761	Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000 Calibrators…	Lin-Zhi International, Inc.	2012	—
+2	K141803	Immunalysis Tramadol Urine Enzyme Immunoassay	Immunalysis Corporation	2015	—
+1	K110298	Opiate Enzyme Immunoassay	Lin-Zhi International, Inc.	2011	—
+3	K203527	Immunalysis Tapentadol Urine HEIA	Lmmunalysis Corporation	2022	—
+2	K172416	Synermed Opiate Enzyme Immunoassay	Infrared Laboratory Systems, LLC (Dba Synermed)	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2011	1	0
2012	1	0
2015	1	0
2018	1	0
2022	1	0

FIG. 1 — Lineage of K020368, 2001–2022Source: 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 DJG? 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 DJG device

#1 K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek®…score 17.6 · 8 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? (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
*	K011150	Dridau Opiate Assay	Microgenics Corp.	2001	—

Also cleared against K011150: 1 other device →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K120761	Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000 Calibrators, Lzi Opiate…	Lin-Zhi International, Inc.	2012	2
K110298	Opiate Enzyme Immunoassay	Lin-Zhi International, Inc.	2011	1
K033866	Camp Multiple Analyte Enzyme Immunoassay, Cat.# 0510, 0511 (500 & 5000 Test Kits)	Lin-Zhi International, 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?

Its one ancestor has no recall.
Of its descendants, K120761 (Lin-Zhi International, Inc., 2012) has gone furthest, with 2 descendants of its own.
1 other device also cites its predicate K011150.

How does its category compare?

All DJG devices

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

FDA decisions per year · DJG

3in 2025

2007high 12 (2015) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DJG

31in 2025

2007high 422 (2021) · low 30 (2020)2026

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

Recalls per year · DJG

2in 2025

2007high 2 (2025) · low 0 (2007)2026

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

Adverse event reports per year · DJG

1in 2025

2007high 4 (2011) · low 0 (2007)2025

MAUDE reports naming product code DJG, 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	2	—	0	0
2008	2	—	0	0
2009	2	—	0	0
2010	6	187	0	0
2011	6	233	1	4
2012	5	95	0	1
2013	5	60	0	4
2014	9	62	0	0
2015	12	141	0	3
2016	2	—	0	2
2017	4	101	0	1
2018	5	134	0	1
2019	3	235	1	0
2020	5	30	0	0
2021	3	422	0	2
2022	2	—	0	1
2023	10	140	0	0
2024	5	150	0	3
2025	3	31	2	1
2026	3	157	0	—

What is it indicated for?

The Opiate Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 300

ng/dL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses

of opiates in human urine.

The Opiate Enzyme Immunoassay provides only a preliminary analytical test result. A more

specific alternative chemical method must be used to obtain a confirmed analytical result.

Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.

Clinical consideration and professional judgement should be applied to any drug-of-abuse

test result, particularly when preliminary positive results are used.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K020368 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020368: Opiate Enzyme Immunoassay, Catalog # 0020 (500 Tests Kit); Catalog # 0021 (5000 Tests Kit).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020368

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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