510(k) · Cleared
ClearedMission Liquid Urine Control, Mission Liquid Diptube Urine Control, Mission Dry Strip Urine Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · JJW Urinalysis Controls (Assayed And Unassayed)
Cleared on Feb 2, 2011 as substantially equivalent to K070848 (Bio-Rad, Diagnostics Grp., 2007) and 1 other predicate after a 76-day review. Its family tree reaches back 4 generations to 1989. 1 later device descends from it.
- Decided
- Feb 2, 2011
- Review
- 76 days
- Class
- Class I
- Product code
- JJW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K890577 (1989). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK890577 Kenlor Liquid Urine ControlKenlor Industries, Inc. · 1989
- 3 generations backK965171 Liquichek Urianlysis Control (Cat. NO. 420,421,422,425,426)Bio-Rad · 1997
- 2 generations backK031231 Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek…Bio-Rad · 2003
- 1 generation backK070848 Liquichek Urinalysis Control (BI-Level), Control LEVEL1, Level…Bio-Rad, Diagnostics Grp. · 2007
- This deviceK103387 Mission Liquid Urine Control, Mission Liquid Diptube Urine Control…ACON Laboratories, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK142543 Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls…ACON Laboratories, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K142543Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube…ACON Laboratories, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K890577 | Kenlor Liquid Urine Control | Kenlor Industries, Inc. | 1989 | — |
| −3 | K965171 | Liquichek Urianlysis Control (Cat. NO. 420,421,422,425,426) | Bio-Rad | 1997 | — |
| −2 | 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 | — |
| 0 (this device) | K103387 | Mission Liquid Urine Control, Mission Liquid Diptube Urine Control, Mission… | ACON Laboratories, Inc. | 2011 | — |
| +1 | K142543 | Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission… | ACON Laboratories, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (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 | Decided |
|---|---|---|---|
| * | K070848 | Liquichek Urinalysis Control (BI-Level), Control LEVEL1, Level 2,Minipak, 435,436,437,435XSummary page 2…sayed) Medical Specialty: Clinical Chemistry Predicate Device: Bio-Rad LiquicheckTm Urinalysis Control Bio-Rad Laboratories, Hercules, CA 94547 USA 510(k) Numnber: K070848 Chek-Stix® Positive and Negative Control Strips for Urine Chemistry Siemens Healthcare Diagnostics Inc., Tarrytown NY 10591 USA… | 2007 |
| * | K931467 | Chek-Stix Control Strips for UrinalysisSummary page 2…A 510(k) Numnber: K070848 Chek-Stix® Positive and Negative Control Strips for Urine Chemistry Siemens Healthcare Diagnostics Inc., Tarrytown NY 10591 USA 510(k) Number: K93 1467 (Original submitter: Heraeus Kulzer Inc.) Description: The Mission Liquid Urine Control and Mission Liquid Diptube Urine Contr… | 1993 |
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 |
|---|---|---|---|
| K142543 | Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube… | 2015 | 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 22 years and passes through 4 companies; a new generation was cleared every 6.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K142543 (ACON Laboratories, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K070848.
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. 2011, this device’s year, is highlighted.
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?
The Mission Liquid Urine Control, Mission Liquid Diptube Urine Control and Mission Dry Strip Urine Control are assayed urine controls intended for use in validating the precision of visual and analyzer reading of urinalysis for one or more of the following analytes: Ascorbic acid, Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes. It is intended for professional in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103387 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103387: Mission Liquid Urine Control, Mission Liquid Diptube Urine Control, Mission Dry Strip Urine Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103387
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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