Product Manual

1
Section 1 Introduction
The Clarity Urocheck 120C Urine Analyzer reads urine test strips. It stores results and
prints reports without the need for special training.
The Clarity Urocheck 120C Urine Analyzer runs a self-test each time the power switch
is turned on. An optional barcode reader records patient ID. The barcode reader verifies
strip canister barcodes. Use only Clarity
Urinalysis Reagent Strips with the canister
barcode for correct results.
The Clarity Urocheck 120C Urine Analyzer is CLIA waived when used with the Clarity
Urinalysis Reagent Strips. Only laboratories with a Certificate of CLIA Waiver may use
this analyzer in a waived setting. Users should read this complete test procedure before
performing a test using this analyzer. Failure to adhere to these instructions for use and
for performing QC testing is considered off-label use. Off-label use is categorized as
high complexity and subject to all CLIA regulations.
Intended Use
The Clarity Urocheck 120C Urine Analyzer is intended for use in conjunction with the
Clarity Urinalysis Reagent Strips for the semi-quantitative detection of the following
analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, pH,
Blood, Protein, Urobilinogen, Leukocytes, as well as the qualitative detection of Nitrite.
The instrument is intended for professional, in vitro diagnostic use only. The
measurement can be used in general evaluation of health, and aids in the diagnosis
and monitoring of metabolic or systemic diseases that affect kidney function, endocrine
disorders and diseases or disorders of the urinary tract.
Note: Keys on the Keypad are listed in bold. Display items on the screen
are listed in bold italics in the manual.