510(k) · Cleared
ClearedMission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine )
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · JFY Enzymatic Method, Creatinine
Cleared on Dec 22, 2014 as substantially equivalent to K031947 (Bayer Healthcare, LLC, 2003) and 2 other predicates after a 117-day review. Its family tree reaches back 4 generations to 1989. 3 later devices descend from it.
- Decided
- Dec 22, 2014
- Review
- 117 days
- Class
- Class II
- Product code
- JFY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K890577 (1989). 9 ancestors in all. 3 later devices descend from it, 2 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 deviceK142391 Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips…ACON Laboratories, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK182384 ACR LAB Urine Analysis Test SystemHealthy.Io, Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK252619 Qscheck UisacrQstag, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK232317 UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips…Urit Medical Electronic Co., Ltd. · 2024
Most influential descendants
Showing 3 of 3 · See all- K182384ACR LAB Urine Analysis Test SystemHealthy.Io, Ltd. · 2019 · cites it directly1descendant
- K252619Qscheck UisacrQstag, Inc. · 2026 · 2 generations on0descendants
- K232317UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine…Urit Medical Electronic Co., Ltd. · 2024 · 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) | K142391 | Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips (… | ACON Laboratories, Inc. | 2014 | — |
| +1 | K182384 | ACR LAB Urine Analysis Test System | Healthy.Io, Ltd. | 2019 | — |
| +2 | K252619 | Qscheck Uisacr | Qstag, Inc. | 2026 | — |
| +1 | K232317 | UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA… | Urit Medical Electronic Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 JFY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JFY device
- #1 K252619 Qscheck Uisacrscore 12.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K031947 | Bayer Clinitek Status AnalyzerSummary page 5…(Assayed And Unassayed) Predicate Device: Bayer Clinitek Status Analyzer BAYER HEALTHCARE, LLC 63 North St. Medfield, MA 02052 -1688 510(k) Number: K031947 CLINITEK Microalbumin Reagent Strips BAYER CORPORATION 1884 Miles Avenue, P.O. Box 70 Elkhart, IN 46515 510… | 2003 |
| * | K972706 | Clinitek Microalbumin Reagent StripsSummary page 5…8 510(k) Number: K031947 CLINITEK Microalbumin Reagent Strips BAYER CORPORATION 1884 Miles Avenue, P.O. Box 70 Elkhart, IN 46515 510(k) Number: K972706 Biorad Liquicheck Urinalysis control BIO-RAD 9500 Jeronimo Rd. Irvine, CA 92618 510(k) Number: k070848 Devi… | 1997 |
| * | K070848 | Liquichek Urinalysis Control (BI-Level), Control LEVEL1, Level 2,Minipak, 435,436,437,435XSummary page 5…x 70 Elkhart, IN 46515 510(k) Number: K972706 Biorad Liquicheck Urinalysis control BIO-RAD 9500 Jeronimo Rd. Irvine, CA 92618 510(k) Number: k070848 Device Name: Mission® U120 Ultra Urine Analyzer, Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine)… | 2007 |
What descends from it? (3)
2 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 25 years and passes through 4 companies; a new generation was cleared every 7.7 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K182384 (Healthy.Io, Ltd., 2019) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K031947.
How does its category compare?
All JFY devicesJFY Enzymatic Method, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · JFY
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JFY
59in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JFY
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JFY
61in 2025
MAUDE reports naming product code JFY, 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 | 8 | 193 | 0 | 1 |
| 2008 | 4 | 170 | 2 | 4 |
| 2009 | 3 | 59 | 3 | 22 |
| 2010 | 0 | — | 3 | 22 |
| 2011 | 2 | — | 0 | 42 |
| 2012 | 0 | — | 0 | 24 |
| 2013 | 0 | — | 1 | 39 |
| 2014 | 2 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 1 | — | 0 | 16 |
| 2017 | 1 | — | 0 | 16 |
| 2018 | 2 | — | 0 | 34 |
| 2019 | 2 | — | 0 | 56 |
| 2020 | 0 | — | 0 | 34 |
| 2021 | 2 | — | 0 | 57 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 0 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 34 |
| 2025 | 0 | — | 0 | 61 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Mission® U120 Ultra Urine Analyzer is an urinalysis instrument intended for in vitro diagnostic use. It is intended
for professional use only at point-of-care locations. The Mission U120 Ultra Urine Analyzer is intended to read Mission®
Urinalysis Reagent strips (Microalbumin/Creatinine) for the semi quantitative measurement of Albumin and Creatinine.
These measurements are used to assist diagnosis for kidney function.
The Mission® Liquid Urine Controls and Mission® Liquid Diptube Urine Controls are assayed urine controls, intended
for use in validating the precision of analyzer reading of urinalysis for the Creatinine and Albumin analytes.
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/K142391 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142391: Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142391
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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