Introduction; Intended Use - Clarity Platinum Operator's Manual

Clarity Platinum Urine Analyzer
OPERATOR'S MANUAL

1. Introduction

The introduction explains how to unpack, install, and begin using the Clarity
Platinum Urine Analyzer. The introduction also includes an overview of the
analyzer and its key features.
The Clarity Platinum Urine Analyzer Test System is for CLIA Waived Use and
only to be used with Clarity Diagnostic's Urine Reagent (CLA-10P) Strips. This
test is waived under the CLIA '88 regulations. This test is only waived for urine
specimens, and failure to adhere to the instructions for use will result in the
test being considered high complexity and subject to all CLIA requirements.
A CLIA Certificate of Waiver is required to perform this test. A Certificate of
Waiver can be obtained from the Centers for Medicare & Medicaid Services
(CMS). Visit www.cms.gov to obtain an application (Form CMS-116). You must
follow the manufacturer's instructions to perform tests. You should read the
complete test procedure before performing the test.

Intended Use

The Clarity Platinum analyzer is a benchtop analyzer designed to read Clarity's
proprietary urinalysis strips (CLA-10P). The instrument is intended to be
used together with Clarity Diagnostics' Urine Reagent Strips as a system for
semi-quantitative detection of Glucose, Bilirubin, Ketone, Specific Gravity,
Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes in urine. These
measurements are used to aid in the diagnosis of metabolic disorders,
kidney function anomalies, urinary tract infections, and liver function.
Tests performed by the Clarity Platinum analyzer are intended for in vitro
diagnostic use only.
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