510(k) · Cleared

Recalled · 2011

Multiple Analyte Urine Drugs of Abuse Calibrators and Controls

K051088510(k) TraditionalCleared Jun 24, 200557-day reviewClass II21 CFR 862.3200Recalls 3

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. · DKB Calibrators, Drug Mixture

Cleared on Jun 24, 2005 as substantially equivalent to K993755 (Syva Co., 1999) and 1 other predicate after a 57-day review. Its family tree reaches back 1 generation to 1998. 6 later devices descend from it. It has been recalled 3 times.

Decided: Jun 24, 2005
Review: 57 days
Class: Class II
Product code: DKB
Recalls: 3
Predicates: 2

Its longest line of descent runs back 1 generation to K983159 (1998). 2 ancestors in all. 6 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK983159 Drugs of Abuse Urine Calibrators and ControlsDiagnostic Reagents, Inc. · 1998
This deviceK051088 Multiple Analyte Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc. · 2005
Descendant · cites it directly · 0 of its ownK153693 Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis…Immunalysis Corporation · 2016
Descendant · cites it directly · 0 of its ownK151771 Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis…Immunalysis Corporation · 2016
Descendant · cites it directly · 0 of its ownK152176 Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug…Immunalysis Corporation · 2015
Descendant · cites it directly · 0 of its ownK143502 Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates…Immunalysis Corporation · 2015
Descendant · cites it directly · 0 of its ownK133710 Lzi Multiple Analyte Set a;B;C Drugs of Abuse ControlsLin-Zhi International, Inc. · 2014

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2013high 2 (2015) · low 0 (2017)2026

Most influential descendants

Showing 5 of 6 · See all

K153693Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis Corporation · 2016 · cites it directly0descendants
K151771Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis Corporation · 2016 · cites it directly0descendants
K152176Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis Corporation · 2015 · cites it directly0descendants
K143502Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300…Immunalysis Corporation · 2015 · cites it directly0descendants
K133710Lzi Multiple Analyte Set a;B;C Drugs of Abuse ControlsLin-Zhi International, Inc. · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K983159	Drugs of Abuse Urine Calibrators and Controls	Diagnostic Reagents, Inc.	1998	—
0 (this device)	K051088	Multiple Analyte Urine Drugs of Abuse Calibrators and Controls	Lin-Zhi International, Inc.	2005	—
+1	K153693	Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug…	Immunalysis Corporation	2016	—
+1	K151771	Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug…	Immunalysis Corporation	2016	—
+1	K152176	Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators	Immunalysis Corporation	2015	—
+1	K143502	Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine…	Immunalysis Corporation	2015	—
+1	K133710	Lzi Multiple Analyte Set a;B;C Drugs of Abuse Controls	Lin-Zhi International, Inc.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2014	1	0
2015	2	0
2016	2	0

FIG. 1 — Lineage of K051088, 1998–2016Source: 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 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? (2)

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
*	K993755	Emit Calibrater/Control Level 0, Level 1, Level 2, Level 3, Level 4, Level 5 Summary page 1 …brators and Controls are substantially equivalent to the Drugs of Abuse Urine Calibrators and Controls (Dade Behring, Microgenics), cleared under prernarket notification K993755 (Dade Behring), K983 159 (DRI, now Microgenics). 10 Device D…	Syva Co.	1999	—
*	K983159	Drugs of Abuse Urine Calibrators and Controls Summary page 1 …substantially equivalent to the Drugs of Abuse Urine Calibrators and Controls (Dade Behring, Microgenics), cleared under prernarket notification K993755 (Dade Behring), K983 159 (DRI, now Microgenics). 10 Device Description All of the DA…	Diagnostic Reagents, Inc.	1998	—

Also cleared against K993755: 1 other device →

What descends from it? (6)

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

Number	Device	Applicant	Decided
K153693	Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators	Immunalysis Corporation	2016
K151771	Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators	Immunalysis Corporation	2016
K152176	Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators	Immunalysis Corporation	2015
K143502	Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300…	Immunalysis Corporation	2015
K133710	Lzi Multiple Analyte Set a;B;C Drugs of Abuse Controls	Lin-Zhi International, Inc.	2014
K132090	Benzodiazepine Calibrator Set, Benzodiazepine Control Level 1, and Benzodiazepine…	Randox Laboratories, Ltd.	2013

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 11, 2011	Not classified	Z-0847-2012	Labeling mix-ups	Catalog # 0804 Multi-Analyte Urine DAU Intermediate Calibrators were incorrectly labeled and mistakenly filled with Catalog # 0805 DAU High Calibrators.
Aug 23, 2011	Not classified	Z-0868-2012	Nonconforming Material/Component	Multi Analyte Urine DAU Cutoff Calibrator Gives a decreased absorbance reading due to a loss of the BZO (oxazepam) analyte from the solution and may cause false positive readings.
Aug 5, 2011	Not classified	Z-0838-2012	Error in labeling	Customer complaint investigation found that the Multi-Analyte Urine DAU Level 2 control was incorrectly labeled and actually contained Multi-Analyte DAU Low Level Calibrators.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K153693 (Immunalysis Corporation, 2016) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K993755.

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 Multiple Analyte (Benzoylecgonine, Methamphetamine, Methadone, Morphine, Oxazepam, Secobarbital, Phencyclidine, and Propoxyphene) Urine Drugs of Abuse Calibrators are intended for in vitro diagnostic use for the calibration of their respective enzyme immunoassays to detect d-methainphetamine, benzoylecgonine, opiate, benzodiazepines, barbiturates, methadone, phencyclidine or propoxyphene in human urine. The Multiple Analyte (Benzoylecgonine…

Read the full statement (92 words)

The Multiple Analyte (Benzoylecgonine, Methamphetamine, Methadone, Morphine,

Oxazepam, Secobarbital, Phencyclidine, and Propoxyphene) Urine Drugs of Abuse

Calibrators are intended for in vitro diagnostic use for the calibration of their respective

enzyme immunoassays to detect d-methainphetamine, benzoylecgonine, opiate,

benzodiazepines, barbiturates, methadone, phencyclidine or propoxyphene in human urine.

The Multiple Analyte (Benzoylecgonine, Methamphetamine, Methadone, Morphine,

Oxazepam, Secobarbital, Phencyclidine, and Propoxyphene) Urine Drugs of Abuse Controls

are intended for in vitro diagnostic use for the validation of their respective enzyme

immunoassays to detect d-methamphetamine, benzoylecgonine, opiate, benzodiazepines.

barbiturates, methadone, phencyclidine or propoxyphene in human urine.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051088 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051088: Multiple Analyte Urine Drugs of Abuse Calibrators and Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051088

Report an extraction error

Are you the manufacturer?

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