# K251800: Healgen® URS Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Healgen Scientific,, LLC
- Decided: Dec 23, 2025 after 194 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 Healgen® URS Test Strips are for the qualitative detection of leukocytes (white blood cells) and nitrite in urine as an aid in the screening of a urinary tract infection (UTI). It is intended for over-the-counter home use only.

Source page: https://510kreport.com/device/K251800
Methodology: https://510kreport.com/methodology