510(k) · Cleared
ClearedUriscreen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diatech Diagnostics,Inc. · JXA Kit, Screening, Urine
Cleared on Oct 7, 1998 after a 196-day review. The FDA summary names its predicate without a number.
- Decided
- Oct 7, 1998
- Review
- 196 days
- Class
- Class I
- Product code
- JXA
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 JXA? 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 |
|---|---|---|---|
| * | — | MULTISTIX- Reagent Strip for Urinalysis Named without a submission number | |
| * | — | Uri-Test - Nitrite in Urine Test Named without a submission number |
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.
How does its category compare?
All JXA devicesJXA Kit, Screening, Urine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JXA
FDA has decided no JXA device since 2007.
Median 510(k) review, days · JXA
Too few JXA 510(k)s in any year since 2007 to give a median.
Recalls per year · JXA
No recall names JXA since 2007.
Adverse event reports per year · JXA
3in 2025
MAUDE reports naming product code JXA, 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 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 15 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Uriscreen is a non-quantitative rapid screen, which detects catalase. Urinary catalase may be associated with White Blood Cells, bacteria and other cells, some of which may be indicators of urinary tract infection. Only Adults should use the test.
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/K981084 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981084: Uriscreen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981084
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026