# K091472: Uritest 50 and Uritest 500 Urine Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Arj Medical, Inc.
- Decided: Apr 27, 2010 after 344 days
- Product code: KQO (Automated Urinalysis System)
- Device class: 1
- Regulation: 21 CFR 862.2900
- 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 K052719 (2006). 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)
- K052719: Uritest 10 Urinalysis Reagent Strips, Arj Medical, Inc. (2006) Summary page 1.

## Indications for use
ARJ Medical URITEST 50 urine analyzer is a semi-automated, bench top instrument which is intended for prescription, in vitro diagnostic use with the URITEST 10 Urinalysis Reagent Strips manufactured by AR] Medical, Inc. This system performs qualitative detection of Nitrites and semi-quantitative detection of Urobilinogen, Bilirubin, Ketone, Blood, Protein, Leukocytes, Glucose, Specific gravity and pH. The instrument uses the accompanying check strip for daily calibration. ARJ Medical URITEST 50 Urinalysis Analyzer is for use in professional near patient (point-of-care) facilities and centralized laboratory. The analyzer is intended for use in screening at-risk patients to assist diagnosis in the following areas: Kidney Function Urinary Tract infections Carbohydrate metabolism Liver Function Acid-Base balance Urine Concentration ARJ Medical Uritest 500 urine analyzer is a semi-automated, bench top instrument which is intended for prescription, in vitro diagnostic use with the URITEST 10 Urinalysis Reagent Strips manufactured by ARJ Medical, Inc. This system performs qualitative detection of Nitrites and semi-quantitative detection of Urobilinogen, Bilirubin, Ketone, Blood, Protein, Leukocytes, Glucose, Specific gravity and pH. The instrument uses the accompanying check strip for daily calibration. ARJ Medical URITEST 500 Urinalysis Analyzer is for use in professional near patient (point-of-care) facilities and centralized laboratory. The analyzer is intended for use in screening at-risk patients to assist diagnosis in the following areas: Kidney Function Urinary Tract infections Carbohydrate metabolism Liver Function Acid-Base balance Urine Concentration

Source page: https://510kreport.com/device/K091472
Methodology: https://510kreport.com/methodology