510(k) · Cleared
ClearedUritest 50 and Uritest 500 Urine Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arj Medical, Inc. · KQO Automated Urinalysis System
Cleared on Apr 27, 2010 as substantially equivalent to K052719 (Arj Medical, Inc., 2006) after a 344-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Apr 27, 2010
- Review
- 344 days
- Class
- Class I
- Product code
- KQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K052719 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK052719 Uritest 10 Urinalysis Reagent StripsArj Medical, Inc. · 2006
- This deviceK091472 Uritest 50 and Uritest 500 Urine AnalyzerArj Medical, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K052719 | Uritest 10 Urinalysis Reagent Strips | Arj Medical, Inc. | 2006 | — |
| 0 (this device) | K091472 | Uritest 50 and Uritest 500 Urine Analyzer | Arj Medical, Inc. | 2010 | — |
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 KQO? 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 |
|---|---|---|---|
| * | K052719 | Uritest 10 Urinalysis Reagent StripsSummary page 1…675) - Class I Legally marketed devices which we are claiming equivalence: ARJ Medical Uritest 10 Reagent Strips in conjunction with Bayer Clinitek 50 and 500 - k052719 Device Description: ARJ Medical Uritest 50 and Uritest 500 urine analyzer is a kind of semi-automatic… | 2006 |
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.
- 1 other device also cites its predicate K052719.
How does its category compare?
All KQO devicesKQO Automated Urinalysis System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KQO
2in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KQO
Too few KQO 510(k)s in any year since 2007 to give a median.
Recalls per year · KQO
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KQO
12in 2025
MAUDE reports naming product code KQO, 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 | 4 |
| 2009 | 1 | — | 0 | 9 |
| 2010 | 2 | — | 7 | 3 |
| 2011 | 2 | — | 2 | 8 |
| 2012 | 0 | — | 0 | 15 |
| 2013 | 1 | — | 1 | 92 |
| 2014 | 1 | — | 0 | 106 |
| 2015 | 2 | — | 0 | 238 |
| 2016 | 0 | — | 1 | 373 |
| 2017 | 0 | — | 0 | 20 |
| 2018 | 0 | — | 0 | 25 |
| 2019 | 0 | — | 2 | 64 |
| 2020 | 0 | — | 0 | 21 |
| 2021 | 0 | — | 1 | 13 |
| 2022 | 0 | — | 0 | 15 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 0 | — | 0 | 20 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
ARJ Medical URITEST 50 urine analyzer is a semi-automated, bench top instrument which is intended for prescription, in vitro diagnostic use with the URITEST 10 Urinalysis Reagent Strips manufactured by AR] Medical, Inc. This system performs qualitative detection of Nitrites and semi-quantitative detection of Urobilinogen, Bilirubin, Ketone, Blood, Protein, Leukocytes, Glucose, Specific gravity and pH. The instrument uses the accompanying check strip for…
Read the full statement (226 words)
ARJ Medical URITEST 50 urine analyzer is a semi-automated, bench top instrument which is intended for prescription, in vitro diagnostic use with the URITEST 10 Urinalysis Reagent Strips manufactured by AR] Medical, Inc. This system performs qualitative detection of Nitrites and semi-quantitative detection of Urobilinogen, Bilirubin, Ketone, Blood, Protein, Leukocytes, Glucose, Specific gravity and pH. The instrument uses the accompanying check strip for daily calibration.
ARJ Medical URITEST 50 Urinalysis Analyzer is for use in professional near patient (point-of-care) facilities and centralized laboratory. The analyzer is intended for use in screening at-risk patients to assist diagnosis in the following areas:
Kidney Function
Urinary Tract infections
Carbohydrate metabolism
Liver Function
Acid-Base balance
Urine Concentration
ARJ Medical Uritest 500 urine analyzer is a semi-automated, bench top instrument which is intended for prescription, in vitro diagnostic use with the URITEST 10 Urinalysis Reagent Strips manufactured by ARJ Medical, Inc. This system performs qualitative detection of Nitrites and semi-quantitative detection of Urobilinogen, Bilirubin, Ketone, Blood, Protein, Leukocytes, Glucose, Specific gravity and pH. The instrument uses the accompanying check strip for daily calibration.
ARJ Medical URITEST 500 Urinalysis Analyzer is for use in professional near patient (point-of-care) facilities and centralized laboratory. The analyzer is intended for use in screening at-risk patients to assist diagnosis in the following areas:
Kidney Function
Urinary Tract infections
Carbohydrate metabolism
Liver Function
Acid-Base balance
Urine Concentration
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091472 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091472: Uritest 50 and Uritest 500 Urine Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091472
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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