# K231045: Healgen URS Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Healgen Scientific,, LLC
- Decided: Jun 16, 2023 after 65 days
- Product code: LJX (Test, Urine Leukocyte)
- Device class: 1
- Regulation: 21 CFR 864.7675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K905396 (1991). 2 ancestors in all.
3 later devices descend from it; 3 cite 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)
- K100024: Teco Diagnostics Uti Detection Strips, Teco Diagnostics (2011) Summary page 4.

## Most influential descendants
- 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 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/K231045
Methodology: https://510kreport.com/methodology