# K990873: Dbest Urinary Tract Infection Test Kit for Home-Use

- Pathway: 510(k) (Traditional)
- Applicant: Ameritek, Inc.
- Decided: Sep 1, 1999 after 169 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
dBest Urinary Tract Infection Test Kit for Home-Use is a simple one step urinalysis assay for rapid, semi-quantitative detection of the presence of Nitrite and Protein in human urine to aid in the diagnosis of urinary track infection. The dBest Urinary Tract Infection Kits are for home-use only.

Source page: https://510kreport.com/device/K990873
Methodology: https://510kreport.com/methodology