510(k) · Cleared
ClearedUritest 10 Urinalysis Reagent Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arj Medical, Inc. · CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
Cleared on Dec 5, 2006 after a 432-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Dec 5, 2006
- Review
- 432 days
- Class
- Class I
- Product code
- CDM
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK052719 Uritest 10 Urinalysis Reagent StripsArj Medical, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK082811 Uritest 10G & 11G Urine Reagent Strips and Uritest-50 and…Urit Medical Electronic Co., Ltd. · 2009
- Descendant · 2 generations on · 0 of its ownK232317 UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips…Urit Medical Electronic Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK091472 Uritest 50 and Uritest 500 Urine AnalyzerArj Medical, Inc. · 2010
Most influential descendants
Showing 3 of 3 · See all- K082811Uritest 10G & 11G Urine Reagent Strips and Uritest-50 and Uritest-500B Urine AnalyzersUrit Medical Electronic Co., Ltd. · 2009 · cites it directly1descendant
- K232317UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine…Urit Medical Electronic Co., Ltd. · 2024 · 2 generations on0descendants
- K091472Uritest 50 and Uritest 500 Urine AnalyzerArj Medical, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052719 | Uritest 10 Urinalysis Reagent Strips | Arj Medical, Inc. | 2006 | — |
| +1 | K082811 | Uritest 10G & 11G Urine Reagent Strips and Uritest-50 and Uritest-500B Urine… | Urit Medical Electronic Co., Ltd. | 2009 | — |
| +2 | K232317 | UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA… | Urit Medical Electronic Co., Ltd. | 2024 | — |
| +1 | K091472 | Uritest 50 and Uritest 500 Urine Analyzer | Arj Medical, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2024 | 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 CDM? 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 |
|---|---|---|---|
| * | — | Bayer Corporation MULTTSTIX 10 SG Reagent Strips Named without a submission number |
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?
- Of its descendants, K082811 (Urit Medical Electronic Co., Ltd., 2009) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CDM devicesCDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CDM
FDA has decided no CDM device since 2007.
Median 510(k) review, days · CDM
Too few CDM 510(k)s in any year since 2007 to give a median.
Recalls per year · CDM
No recall names CDM since 2007.
Adverse event reports per year · CDM
3in 2025
MAUDE reports naming product code CDM, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
URITEST 10 Urinalysis Reagent Strips provide qualitative and semni-quantitative tests for glucose, bilimbin, ketones (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen, nitrites, and leukocytes in urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance, and bacteriuria. ARJ Medical URITEST 10 Urinalysis Reagent Strips are for single use in professional…
Read the full statement (135 words)
URITEST 10 Urinalysis Reagent Strips provide qualitative and semni-quantitative tests for glucose, bilimbin, ketones (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen, nitrites, and leukocytes in urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance, and bacteriuria.
ARJ Medical URITEST 10 Urinalysis Reagent Strips are for single use in professional near patient (point-of-care) facilities and centralized laboratory locations by medical technologists both read visually and on the Bayer Family of Clinitek Analyzers. The strips are intended of 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
Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052719: Uritest 10 Urinalysis Reagent Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052719
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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