510(k) · Cleared

Cleared

Liquichek Urine Toxicology Control Level C1, Liquichek Urine Toxicology Control Level C2, Liquichek Urine Toxicology Con

K981590510(k) TraditionalCleared Jun 10, 199837-day reviewClass I21 CFR 862.3280

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

Bio-Rad · DIF Drug Mixture Control Materials

Cleared on Jun 10, 1998 as substantially equivalent to K903430 (Bio-Rad, 1990) after a 37-day review. Its family tree reaches back 1 generation to 1990. 8 later devices descend from it.

Decided: Jun 10, 1998
Review: 37 days
Class: Class I
Product code: DIF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K903430 (1990). 8 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK903430 Liquichek CK/LD Isoenzyme Control; Levels 1 and 2Bio-Rad · 1990
This deviceK981590 Liquichek Urine Toxicology Control Level C1, Liquichek Urine…Bio-Rad · 1998
Descendant · cites it directly · 2 of its ownK021384 Liquichek Urine Toxicology Control Levels C1-C4, Models…Bio-Rad · 2002
Descendant · cites it directly · 2 of its ownK012999 Triage Tox Drug Screen Controls, Catalog #94001Biosite Incorporated · 2001
Descendant · cites it directly · 1 of its ownK050037 Triage Tox Drug Screen ControlsBiosite Incorporated · 2005
Descendant · 2 generations on · 1 of its ownK033404 Liquichek Urine Toxicology Control (Confirmatory Series)Bio-Rad · 2003
Descendant · 2 generations on · 0 of its ownK060788 Triage Tox Drug Screen Control Level 1 Model 94413 and Level 2 Model…Biosite Incorporated · 2006 · Recalled

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2001high 2 (2001) · low 0 (2004)2026

Most influential descendants

Showing 5 of 8 · See all

K021384Liquichek Urine Toxicology Control Levels C1-C4, Models 441,442,443,444Bio-Rad · 2002 · cites it directly2descendants
K012999Triage Tox Drug Screen Controls, Catalog #94001Biosite Incorporated · 2001 · cites it directly2descendants
K050037Triage Tox Drug Screen ControlsBiosite Incorporated · 2005 · cites it directly1descendant
K033404Liquichek Urine Toxicology Control (Confirmatory Series)Bio-Rad · 2003 · 2 generations on1descendant
K060788Triage Tox Drug Screen Control Level 1 Model 94413 and Level 2 Model 94414Biosite Incorporated · 2006 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K903430	Liquichek CK/LD Isoenzyme Control; Levels 1 and 2	Bio-Rad	1990	—
0 (this device)	K981590	Liquichek Urine Toxicology Control Level C1, Liquichek Urine Toxicology…	Bio-Rad	1998	—
+1	K021384	Liquichek Urine Toxicology Control Levels C1-C4, Models 441,442,443,444	Bio-Rad	2002	—
+1	K012999	Triage Tox Drug Screen Controls, Catalog #94001	Biosite Incorporated	2001	—
+1	K050037	Triage Tox Drug Screen Controls	Biosite Incorporated	2005	—
+2	K033404	Liquichek Urine Toxicology Control (Confirmatory Series)	Bio-Rad	2003	—
+2	K060788	Triage Tox Drug Screen Control Level 1 Model 94413 and Level 2 Model 94414	Biosite Incorporated	2006	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	2	0
2002	2	0
2003	1	0
2005	2	0
2006	1	0

FIG. 1 — Lineage of K981590, 1990–2006Source: 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 DIF? 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

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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
*	K903430	Liquichek CK/LD Isoenzyme Control; Levels 1 and 2 Summary page 1 …862.3280: Drug Mixture Control 91DIF Devices to Which Substantial Equivalence is Claimed Liquid Drugs of Abuse Controls Medical Analysis Systems, Camarillo, California K903430 Statement of Intended Use Liguichek Urine Toxicology Control is intended for use as a quality control urine to monitor the perfo…	Bio-Rad	1990	—

Also cleared against K903430: 1 other device →

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K021384	Liquichek Urine Toxicology Control Levels C1-C4, Models 441,442,443,444	Bio-Rad	2002	2
K012999	Triage Tox Drug Screen Controls, Catalog #94001	Biosite Incorporated	2001	2
K050037	Triage Tox Drug Screen Controls	Biosite Incorporated	2005	1
K021415	Liquichek Urine Toxicology Control Level C2 Low Opiate & C3 Low Opiate Models 468 & 469	Bio-Rad	2002	0
K013002	Triage Tox Drug Screen Calibration Verification Controls, Catalog #94002	Biosite Incorporated	2001	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, K021384 (Bio-Rad, 2002) has gone furthest, with 2 descendants of its own.
1 other device also cites its predicate K903430.

How does its category compare?

All DIF devices

DIF Drug Mixture Control Materials: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DIF

1in 2016

2007high 3 (2012) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DIF

35in 2012

2007high 35 (2012)2026

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

Recalls per year · DIF

1in 2021

2007high 5 (2017) · low 0 (2007)2026

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

Adverse event reports per year · DIF

1in 2016

2007high 3 (2012) · low 0 (2007)2025

MAUDE reports naming product code DIF, 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	1	—	0	0
2008	2	—	0	0
2009	0	—	0	0
2010	1	—	0	0
2011	1	—	1	1
2012	3	35	0	3
2013	2	—	1	0
2014	0	—	0	0
2015	0	—	0	0
2016	1	—	0	1
2017	0	—	5	0
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	1	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K981590 · printed Nov 6, 2026

Cite this page

510(k) Report. “K981590: Liquichek Urine Toxicology Control Level C1, Liquichek Urine Toxicology Control Level C2, Liquichek Urine Toxicology Con.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981590

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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