510(k) · Cleared
Recalled · Class II · 2023Ind Urinary Tract Infection (Uti) Test Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ind Diagnostic, Inc. · NGJ Test, Nitrite, Urinary, Non-Quantitative, Over The Counter
Cleared on Apr 17, 2012 after a 551-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Apr 17, 2012
- Review
- 551 days
- Class
- Class I
- Product code
- NGJ
- Recalls
- 1
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NGJ? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 22, 2023 | Class II | Z-0045-2024 | Other | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All NGJ devicesNGJ Test, Nitrite, Urinary, Non-Quantitative, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · NGJ
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · NGJ
Too few NGJ 510(k)s in any year since 2007 to give a median.
Recalls per year · NGJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NGJ
No MAUDE report names NGJ since 2007.
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 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 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 | — | 1 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IND Urinary Tract Infection (UTI) Test Strips are intended for qualitative detection of nitrite and leukocytes in urine as an aid in the screening of urinary tract infection in persons with signs and symptoms of urinary tract infection. Testing of urine is performed by urinating into a sample cup and briefly dipping the test strip into it. This test is intended for over-the-counter home use only.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K103037 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103037: Ind Urinary Tract Infection (Uti) Test Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103037
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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