# K242767: Safecare Urinary Tract Infection Test

- Pathway: 510(k) (Traditional)
- Applicant: Safecare Biotech (Hangzhou) Co., Ltd.
- Decided: Jan 10, 2025 after 119 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: 3 generations back to K905396 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231045: Healgen URS Test Strips, Healgen Scientific,, LLC (2023) Summary page 5.

## Indications for use
The Safecare Urinary Tract Infection Test is for the qualitative detection of Leukocytes (LEU,white blood cells) and nitrite (NIT) in urine as an aid in the screening of a Urinary Tract infection (UTI). It is intended for over-the-counter home use.

Source page: https://510kreport.com/device/K242767
Methodology: https://510kreport.com/methodology