# K103037: Ind Urinary Tract Infection (Uti) Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Ind Diagnostic, Inc.
- Decided: Apr 17, 2012 after 551 days
- Product code: NGJ (Test, Nitrite, Urinary, Non-Quantitative, Over The Counter)
- Device class: 1
- Regulation: 21 CFR 862.1510
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- May 22, 2023 · Class II · Z-0045-2024: 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" Ke

## Indications for use
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.

Source page: https://510kreport.com/device/K103037
Methodology: https://510kreport.com/methodology