510(k) · Cleared

Cleared

Liquichek Urianlysis Control (Cat. NO. 420,421,422,425,426)

K965171510(k) TraditionalCleared Jan 13, 199720-day reviewClass I21 CFR 862.1660

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

Bio-Rad · JJY Multi-Analyte Controls, All Kinds (Assayed)

Cleared on Jan 13, 1997 as substantially equivalent to K890577 (Kenlor Industries, Inc., 1989) after a 20-day review. Its family tree reaches back 1 generation to 1989. 10 later devices descend from it.

Decided: Jan 13, 1997
Review: 20 days
Class: Class I
Product code: JJY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K890577 (1989). 10 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK890577 Kenlor Liquid Urine ControlKenlor Industries, Inc. · 1989
This deviceK965171 Liquichek Urianlysis Control (Cat. NO. 420,421,422,425,426)Bio-Rad · 1997
Descendant · cites it directly · 9 of its ownK031231 Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek…Bio-Rad · 2003
Descendant · 2 generations on · 6 of its ownK070848 Liquichek Urinalysis Control (BI-Level), Control LEVEL1, Level…Bio-Rad, Diagnostics Grp. · 2007
Descendant · 3 generations on · 3 of its ownK142391 Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips…ACON Laboratories, Inc. · 2014
Descendant · 4 generations on · 1 of its ownK182384 ACR LAB Urine Analysis Test SystemHealthy.Io, Ltd. · 2019
Descendant · 3 generations on · 1 of its ownK103387 Mission Liquid Urine Control, Mission Liquid Diptube Urine Control…ACON Laboratories, Inc. · 2011

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2003high 1 (2003) · low 0 (2006)2026

Most influential descendants

Showing 5 of 10 · See all

K031231Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek Urinalysis Control Level 2…Bio-Rad · 2003 · cites it directly9descendants
K070848Liquichek Urinalysis Control (BI-Level), Control LEVEL1, Level 2,Minipak, 435,436,437,435XBio-Rad, Diagnostics Grp. · 2007 · 2 generations on6descendants
K142391Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips (…ACON Laboratories, Inc. · 2014 · 3 generations on3descendants
K182384ACR LAB Urine Analysis Test SystemHealthy.Io, Ltd. · 2019 · 4 generations on1descendant
K103387Mission Liquid Urine Control, Mission Liquid Diptube Urine Control, Mission Dry Strip…ACON Laboratories, Inc. · 2011 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K890577	Kenlor Liquid Urine Control	Kenlor Industries, Inc.	1989	—
0 (this device)	K965171	Liquichek Urianlysis Control (Cat. NO. 420,421,422,425,426)	Bio-Rad	1997	—
+1	K031231	Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek Urinalysis Control…	Bio-Rad	2003	—
+2	K070848	Liquichek Urinalysis Control (BI-Level), Control LEVEL1, Level 2,Minipak…	Bio-Rad, Diagnostics Grp.	2007	—
+3	K142391	Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips (…	ACON Laboratories, Inc.	2014	—
+4	K182384	ACR LAB Urine Analysis Test System	Healthy.Io, Ltd.	2019	—
+3	K103387	Mission Liquid Urine Control, Mission Liquid Diptube Urine Control, Mission…	ACON Laboratories, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0
2005	1	0
2007	1	0
2011	1	0
2014	1	0
2015	1	0
2019	1	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K965171, 1989–2026Source: 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 JJY? 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? (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
*	K890577	Kenlor Liquid Urine Control Summary page 1 …e CFR 862.1660: Urinalysis Controls (Assayed and Unassayed) Devices to Which Substantial Equivalence is Claimed Liquid Urine Control Kenlor Industries Westminister, CA K890577 Statement of Intended Use Liquichek Urinalysis Control is intended for use as an assayed quality control urine to monitor the pr…	Kenlor Industries, Inc.	1989	—

Also cleared against K890577: 1 other device →

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K031231	Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek Urinalysis Control Level 2…	Bio-Rad	2003	9
K050328	Pregnancy-Skreen	Biochemical Diagnostic, Inc.	2005	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, K031231 (Bio-Rad, 2003) has gone furthest, with 9 descendants of its own.
1 other device also cites its predicate K890577.

How does its category compare?

All JJY devices

JJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJY

3in 2017

2007high 16 (2013) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJY

78in 2017

2007high 153 (2015) · low 40 (2012)2026

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

Recalls per year · JJY

2in 2025

2007high 6 (2010) · low 0 (2008)2026

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

Adverse event reports per year · JJY

13in 2025

2007high 20 (2012) · low 0 (2022)2025

MAUDE reports naming product code JJY, 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	11	49	5	2
2008	7	54	0	1
2009	8	80	2	3
2010	10	109	6	3
2011	14	120	1	6
2012	13	40	3	20
2013	16	82	2	5
2014	10	49	2	4
2015	4	153	1	4
2016	1	—	3	13
2017	3	78	4	12
2018	0	—	3	7
2019	0	—	4	1
2020	0	—	6	7
2021	0	—	0	1
2022	0	—	3	0
2023	0	—	3	4
2024	0	—	0	1
2025	0	—	2	13
2026	0	—	1	—

What is it indicated for?

Liquichek Urinalysis Control is intended for use as an assayed quality control urine to monitor the precision of laboratory dipstick and microscopic testing procedures for the analytes listed in the package insert.

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/K965171 · printed Nov 4, 2026

Cite this page

510(k) Report. “K965171: Liquichek Urianlysis Control (Cat. NO. 420,421,422,425,426).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965171

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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