# K100024: Teco Diagnostics Uti Detection Strips

- Pathway: 510(k) (Traditional)
- Applicant: Teco Diagnostics
- Decided: Feb 17, 2011 after 408 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 K905396 (1991). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905396: Hemastix Reagent Strips, Heraeus Kulzer, Inc. (1991) Summary page 2.

## Most influential descendants
- K231045: Healgen URS Test Strips (2023), 3 descendants of its own
- K251800: Healgen® URS Test Strips (2025), 0 descendants of its own
- K252607: AllTest Urinary Tract Infection Test (2025), 0 descendants of its own
- K242767: Safecare Urinary Tract Infection Test (2025), 0 descendants of its own

## Indications for use
The Teco Diagnostics UTI Test Strips are intended for the qualitative detection of Nitrite and Leukocytes in urine as an aid in the screening of urinary tract infection (UTI). It is intended for over-the-counter home use only.

Source page: https://510kreport.com/device/K100024
Methodology: https://510kreport.com/methodology