510(k) · Cleared
ClearedWiener Lab. Urine Strip 10 and 11
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wiener Laboratorios Saic · JIO Blood, Occult, Colorimetric, In Urine
Cleared on Sep 2, 2009 after a 261-day review. Our reading found no predicate number; beside “510(k)” the summary prints a number our reading could not make out (“k83724”).
- Decided
- Sep 2, 2009
- Review
- 261 days
- Class
- Class II
- Product code
- JIO
- Recalls
- None
- Predicates
- 0
Our reading found no predicate number; beside “510(k)” the summary prints a number our reading could not make out (“k83724”).
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 JIO? 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 JIO device
- #1 K232317 UC-1800 Automatic Urine Analyzer, URIT 11FA…score 8.4 · 5 generations · no Class I recall
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 Multistix® 10SG 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 JIO devicesJIO Blood, Occult, Colorimetric, In Urine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · JIO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JIO
Too few JIO 510(k)s in any year since 2007 to give a median.
Recalls per year · JIO
No recall names JIO since 2007.
Adverse event reports per year · JIO
1in 2025
MAUDE reports naming product code JIO, 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 | 2 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Urine strip test strips are for "in vitro" diagnostic use and are intended for prescription use near-patient (point of care) and centralized laboratory locations. Urine Strip includes test pads for qualitative and semi-quantitative determination of urobilinogen, glucose, ketones, bilirubin, proteins, nitrite, pH, blood, specific gravity, leukocytes and ascorbic acid in urine. Urine test strips results may provide information regarding the status of…
Read the full statement (105 words)
Urine strip test strips are for "in vitro" diagnostic use and are intended for prescription use near-patient (point of care) and centralized laboratory locations.
Urine Strip includes test pads for qualitative and semi-quantitative determination of urobilinogen, glucose, ketones, bilirubin, proteins, nitrite, pH, blood, specific gravity, leukocytes and ascorbic acid in urine.
Urine test strips results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and urinary tract infections. Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.
The test is to be read visually.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083724 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083724: Wiener Lab. Urine Strip 10 and 11.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083724
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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