# K063295: Acon Uti Urinary Tract Infection Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Oct 12, 2007 after 345 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: 1 generation back to K905396 (1991). 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)
- K905396: Hemastix Reagent Strips, Heraeus Kulzer, Inc. (1991) Summary page 2.

## Indications for use
The ACON UTI Urinary Tract Infection Test Strips are 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/K063295
Methodology: https://510kreport.com/methodology