510(k) · Cleared
ClearedLiquicheck Urinalysis Control Bilevel, Model 435, Liquichek Urinalysis Control Level 2, Model 436, Liquichek Urinalysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · JJW Urinalysis Controls (Assayed And Unassayed)
Cleared on Jun 18, 2003 as substantially equivalent to K965171 (Bio-Rad, 1997) after a 61-day review. Its family tree reaches back 2 generations to 1989. 9 later devices descend from it.
- Decided
- Jun 18, 2003
- Review
- 61 days
- Class
- Class I
- Product code
- JJW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K890577 (1989). 9 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK890577 Kenlor Liquid Urine ControlKenlor Industries, Inc. · 1989
- 1 generation backK965171 Liquichek Urianlysis Control (Cat. NO. 420,421,422,425,426)Bio-Rad · 1997
- This deviceK031231 Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek…Bio-Rad · 2003
- Descendant · cites it directly · 6 of its ownK070848 Liquichek Urinalysis Control (BI-Level), Control LEVEL1, Level…Bio-Rad, Diagnostics Grp. · 2007
- Descendant · 2 generations on · 3 of its ownK142391 Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips…ACON Laboratories, Inc. · 2014
- Descendant · 3 generations on · 1 of its ownK182384 ACR LAB Urine Analysis Test SystemHealthy.Io, Ltd. · 2019
- Descendant · 2 generations on · 1 of its ownK103387 Mission Liquid Urine Control, Mission Liquid Diptube Urine Control…ACON Laboratories, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK042446 Quantify Control and Quantify Plus ControlsBio-Rad Laboratories, Inc. · 2004
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K070848Liquichek Urinalysis Control (BI-Level), Control LEVEL1, Level 2,Minipak, 435,436,437,435XBio-Rad, Diagnostics Grp. · 2007 · cites it directly6descendants
- K142391Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips (…ACON Laboratories, Inc. · 2014 · 2 generations on3descendants
- K182384ACR LAB Urine Analysis Test SystemHealthy.Io, Ltd. · 2019 · 3 generations on1descendant
- K103387Mission Liquid Urine Control, Mission Liquid Diptube Urine Control, Mission Dry Strip…ACON Laboratories, Inc. · 2011 · 2 generations on1descendant
- K042446Quantify Control and Quantify Plus ControlsBio-Rad Laboratories, Inc. · 2004 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K890577 | Kenlor Liquid Urine Control | Kenlor Industries, Inc. | 1989 | — |
| −1 | K965171 | Liquichek Urianlysis Control (Cat. NO. 420,421,422,425,426) | Bio-Rad | 1997 | — |
| 0 (this device) | K031231 | Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek Urinalysis Control… | Bio-Rad | 2003 | — |
| +1 | K070848 | Liquichek Urinalysis Control (BI-Level), Control LEVEL1, Level 2,Minipak… | Bio-Rad, Diagnostics Grp. | 2007 | — |
| +2 | K142391 | Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips (… | ACON Laboratories, Inc. | 2014 | — |
| +3 | K182384 | ACR LAB Urine Analysis Test System | Healthy.Io, Ltd. | 2019 | — |
| +2 | K103387 | Mission Liquid Urine Control, Mission Liquid Diptube Urine Control, Mission… | ACON Laboratories, Inc. | 2011 | — |
| +1 | K042446 | Quantify Control and Quantify Plus Controls | Bio-Rad Laboratories, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
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 JJW? 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
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 | Decided |
|---|---|---|---|
| * | K965171 | Liquichek Urianlysis Control (Cat. NO. 420,421,422,425,426)Summary page 1…hich Substantial Equivalence is Claimed LiquichekTMUrinalysis Control Bio-Rad Laboratories Irvine, California Docket Number: K965171 4.0 Description of Device LiquichekTMUrinalysis Control is prepared from human urine with added human… | 1997 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 7.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K070848 (Bio-Rad, Diagnostics Grp., 2007) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K965171.
How does its category compare?
All JJW devicesJJW Urinalysis Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJW
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJW
Too few JJW 510(k)s in any year since 2007 to give a median.
Recalls per year · JJW
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJW
1in 2022
MAUDE reports naming product code JJW, 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 | — | 1 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 7 | 1 |
| 2013 | 0 | — | 1 | 24 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 2 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 2 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Liquichek Urinalysis Control is intended for use as an assayed quality control urine to monitor the precision of urinalysis test procedures for the analytes listed in this package insert.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031231 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031231: Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek Urinalysis Control Level 2, Model 436, Liquichek Urinalysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031231
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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