# K954685: Uritest - Nitrite in Urine Test

- Pathway: 510(k) (Traditional)
- Applicant: Tcpi, Inc.
- Decided: Jul 22, 1996 after 285 days
- Product code: JMT (Diazo (Colorimetric), Nitrite (Urinary, Non-Quant))
- Device class: 1
- Regulation: 21 CFR 862.1510
- Recalls of this device: none
- 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. The FDA summary names its predicate without a number.
- (no number) MULTISTIX- Reagent Strip for Urinalysis: named in the summary without a submission number
- (no number) CHEMSTRIP - Urine Test Strip: named in the summary without a submission number

## Indications for use
UriTest- Nitrite in Urine is a nonquantitative test to identify nitrite in urine. Nitrite identification is used for the detection of Urinary Tract Infection.

Source page: https://510kreport.com/device/K954685
Methodology: https://510kreport.com/methodology