510(k) · Cleared
ClearedMission 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. · JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Cleared on Apr 30, 2015 as substantially equivalent to K972706 (Bayer Corp., 1997) after a 79-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Apr 30, 2015
- Review
- 79 days
- Class
- Class I
- Product code
- JIR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972706 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK972706 Clinitek Microalbumin Reagent StripsBayer Corp. · 1997
- This deviceK150330 Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)ACON Laboratories, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972706 | Clinitek Microalbumin Reagent Strips | Bayer Corp. | 1997 | — |
| 0 (this device) | K150330 | Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) | ACON Laboratories, Inc. | 2015 | — |
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 JIR? 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 JIR device
- #1 K210069 Minuteful - kidney testscore 7.5 · 4 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K972706 | Clinitek Microalbumin Reagent StripsSummary page 5…nine test system Predicate Device: CLINITEK Microalbumin Reagent Strips BAYER CORPORATION 1884 Miles Avenue, P.O. Box 70 Elkhart, IN 46515 510(k) Number: K972706 Device Name: Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) Classification Produ D… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 2 other devices also cite its predicate K972706.
How does its category compare?
All JIR devicesJIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · JIR
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JIR
Too few JIR 510(k)s in any year since 2007 to give a median.
Recalls per year · JIR
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIR
2in 2025
MAUDE reports naming product code JIR, 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 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The Mission Urinalysis Reagent strips (Microalbumin/Creatinine) are intended for the semi quantitative measurement of
albumin and creatinine in urine samples using the Mission U120 Urine Analyzer. These measurements are used to assist
diagnosis for kidney function. It is intended for professional use only at point-of-care locations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150330 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150330: Mission Urinalysis Reagent Strips (Microalbumin/Creatinine).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150330
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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