Clinical Validation Through Analytical Study With Urine Samples to Compare the Effectiveness and Security of an Intelligent Device

S-There Technologies SL700 enrolled

Overview

The objectives of the Clinical Validation Through Analytical Study With Urine Samples to Compare the Effectiveness and Security of an Intelligent Device are: 1.To evaluate the performance of S-There Device in comparison to the golden standard used in the lab.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

700

Conditions

Renal Insufficiency, Chronic Heart Failure Diabete Mellitus Diabetes; Nephropathy (Manifestation)Hematuria Urinary Tract Infections

Interventions

Lab Gold StandardDEVICE

First intervention (assigned to the "All participants" arm).

S-ThereDEVICE

Second intervention (assigned to the "All participants" arm).

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who came to the emergency room, primary care and nephrology unit. Exclusion Criteria: * Subject cannot collect urine in receptacle. * Urinary Catheter

Outcomes

Primary Outcomes

Accuracy to compared device

The primary objective of the study is to evaluate the accuracy of the S-There device compared to the Lab gold standards, for each analyte.

Time frame: Through study completion, an average of 1 month