510(k) · Cleared

Cleared

Drugs of Abuse Urine Calibrators and Controls

K983159510(k) TraditionalCleared Nov 5, 199857-day reviewClass II21 CFR 862.3200

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

Diagnostic Reagents, Inc. · DKB Calibrators, Drug Mixture

Cleared on Nov 5, 1998 after a 57-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 23 later devices descend from it.

Decided: Nov 5, 1998
Review: 57 days
Class: Class II
Product code: DKB
Recalls: None
Predicates: 0

23 later devices descend from it, 4 citing it directly.

This deviceK983159 Drugs of Abuse Urine Calibrators and ControlsDiagnostic Reagents, Inc. · 1998
Descendant · cites it directly · 8 of its ownK012109 Dri Ecstasy Urine CalibratorsMicrogenics Corp. · 2001
Descendant · cites it directly · 6 of its ownK051088 Multiple Analyte Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc. · 2005 · Recalled
Descendant · 2 generations on · 6 of its ownK043028 Emit II Plus Ecstasy AssayDade Behring, Inc. · 2005
Descendant · cites it directly · 5 of its ownK020769 Single Analyte Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc. · 2002
Descendant · 2 generations on · 2 of its ownK120761 Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000…Lin-Zhi International, Inc. · 2012

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2001high 4 (2015) · low 0 (2004)2026

Most influential descendants

Showing 5 of 23 · See all

K012109Dri Ecstasy Urine CalibratorsMicrogenics Corp. · 2001 · cites it directly8descendants
K051088Multiple Analyte Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc. · 2005 · cites it directly6descendants
K043028Emit II Plus Ecstasy AssayDade Behring, Inc. · 2005 · 2 generations on6descendants
K020769Single Analyte Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc. · 2002 · cites it directly5descendants
K120761Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000 Calibrators, Lzi Opiate…Lin-Zhi International, Inc. · 2012 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K983159	Drugs of Abuse Urine Calibrators and Controls	Diagnostic Reagents, Inc.	1998	—
+1	K012109	Dri Ecstasy Urine Calibrators	Microgenics Corp.	2001	—
+1	K051088	Multiple Analyte Urine Drugs of Abuse Calibrators and Controls	Lin-Zhi International, Inc.	2005	3
+2	K043028	Emit II Plus Ecstasy Assay	Dade Behring, Inc.	2005	—
+1	K020769	Single Analyte Urine Drugs of Abuse Calibrators and Controls	Lin-Zhi International, Inc.	2002	—
+2	K120761	Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000 Calibrators…	Lin-Zhi International, Inc.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	2	0
2003	1	0
2005	2	0
2006	3	0
2011	3	0
2012	1	0
2013	1	0
2014	1	0
2015	4	0
2016	2	0
2020	1	0
2022	1	0

FIG. 1 — Lineage of K983159, 1998–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (23)

See all 23

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

Number	Device	Applicant	Decided	Descendants
K012109	Dri Ecstasy Urine Calibrators	Microgenics Corp.	2001	8
K051088	Multiple Analyte Urine Drugs of Abuse Calibrators and Controls	Lin-Zhi International, Inc.	2005	6
K020769	Single Analyte Urine Drugs of Abuse Calibrators and Controls	Lin-Zhi International, Inc.	2002	5
K023316	Single Analyte Urine Drugs of Abuse Calibrators and Controls	Lin-Zhi International, Inc.	2002	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, K012109 (Microgenics Corp., 2001) has gone furthest, with 8 descendants of its own.

How does its category compare?

All DKB devices

DKB Calibrators, Drug Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DKB

2in 2014

2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DKB

Too few DKB 510(k)s in any year since 2007 to give a median.

Recalls per year · DKB

2in 2022

2007high 3 (2009) · low 0 (2007)2026

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

Adverse event reports per year · DKB

1in 2017

2007high 4 (2012) · low 0 (2007)2025

MAUDE reports naming product code DKB, 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	0	—	0	0
2009	2	—	3	0
2010	0	—	0	0
2011	2	—	2	1
2012	1	—	1	4
2013	0	—	0	0
2014	2	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	1
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	2	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

The Multi-Drug Urine Calibrators and Controls are intended to be used for calibration and validation of DRI’s drugs of abuse enzyme immunoassay to detect amphetamines, barbiturates, benzodiazepines, cocaine metabolites, methadone, methaqualone, opiates, phencyclidine and propoxyphene in human urine.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K983159 · printed Nov 4, 2026

Cite this page

510(k) Report. “K983159: Drugs of Abuse Urine Calibrators and Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983159

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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