510(k) · Cleared
ClearedQuantify Control and Quantify Plus Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories, Inc. · JJW Urinalysis Controls (Assayed And Unassayed)
Cleared on Nov 2, 2004 as substantially equivalent to K031231 (Bio-Rad, 2003) after a 54-day review. Its family tree reaches back 3 generations to 1989. 1 later device descends from it.
- Decided
- Nov 2, 2004
- Review
- 54 days
- Class
- Class I
- Product code
- JJW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K890577 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK890577 Kenlor Liquid Urine ControlKenlor Industries, Inc. · 1989
- 2 generations backK965171 Liquichek Urianlysis Control (Cat. NO. 420,421,422,425,426)Bio-Rad · 1997
- 1 generation backK031231 Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek…Bio-Rad · 2003
- This deviceK042446 Quantify Control and Quantify Plus ControlsBio-Rad Laboratories, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK050328 Pregnancy-SkreenBiochemical Diagnostic, Inc. · 2005 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K050328Pregnancy-SkreenBiochemical Diagnostic, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K890577 | Kenlor Liquid Urine Control | Kenlor Industries, Inc. | 1989 | — |
| −2 | 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 | — |
| 0 (this device) | K042446 | Quantify Control and Quantify Plus Controls | Bio-Rad Laboratories, Inc. | 2004 | — |
| +1 | K050328 | Pregnancy-Skreen | Biochemical Diagnostic, Inc. | 2005 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 |
|---|---|---|---|
| * | K031231 | Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek Urinalysis Control Level 2…Summary page 1…Substantial Equivalence is Claimed Liquichek TM Urinalysis Control Bio-Rad Laboratories Irvine, California 510 (k) Number: K031231 4.0 Description of Device These products are a liquid matrix solution prepared with human erythrocytes and [l… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050328 | Pregnancy-Skreen | 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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K050328 (Biochemical Diagnostic, Inc., 2005) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K031231.
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?
qUAntify® Control is intended for use as an assayed quality control to monitor the precision of urinalysis test procedures for the analytes listed in the package insert.
qUAntify® Plus Control is intended for use as an assayed quality control to monitor the precision of urinalysis test procedures for the analytes listed in the package insert.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042446 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042446: Quantify Control and Quantify Plus Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042446
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