# K170118: Scanostics UTI Check Application Test System

- Pathway: 510(k) (Traditional)
- Applicant: Teco Diagnostics
- Decided: Sep 21, 2017 after 251 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
Longest line of descent: 1 generation back to K970250 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970250: Clinistrip, Teco Diagnostics (1997) Summary page 6.

## Indications for use
The Scanostics UTI Check Application test system consists of the Scanostics UTI Check Application and the URS-2L (UTD) Urine Test Strips. The test system is intended for the qualitative detection of nitrite and leukocytes in urine as an aid in the screening of urinary tract infections (UTI). It is intended for over-the-counter home use only.

Source page: https://510kreport.com/device/K170118
Methodology: https://510kreport.com/methodology