Analyticon Urilyzer 100 Pro - Intended Use and Indications for Use

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Appendices
14.5 Urilyzer 100 Intended Use and Indications for Use
Intended Use
The Urilyzer 100 urine analyzer designed specially for professional use, as an
In Vitro Diagnostic Device (IVDD), is designed specifically to improve accuracy
and safety of CombiScreen 11SYS Plus, 7SYS Plus and 5SYS Plus urine strip
evaluation by using light and photometric reader in order to detect the colour
changes on test strips. The analyzer also helps in test data handling and reports
generation by offering data storage and automated data processing features in
medical laboratories.
The Urilyzer 100 urine analyzer works exclusively with CombiScreen 11SYS Plus,
7SYS Plus and 5SYS Plus multi-reagent strip and provides semi-quantitative
reagent concentration values in urine. Tested ingredients are as follows: Bilirubin,
Urobilinogen, Ketones, Ascorbic Acid, Glucose, Protein (Albumin), Blood (Hemo-
globin), pH, Nitrite, Leucocytes and Specific Gravity.
Indications for Use
The Urilyzer 100 urine analyzer is an easy to use, bench top instrument which is
intended for in vitro diagnostic use with CombiScreen 11SYS Plus, 7SYS Plus
and 5SYS Plus reagent strips manufactured by Analyticon. This system performs
semi-quantitative detection of the following analytes in urine: Bilirubin, Urobilino-
gen, Ketones, Ascorbic Acid, Glucose, Protein (Albumin), Blood (Hemoglobin),
pH, Nitrite, Leucocytes and Specific Gravity.
The Urilyzer 100 urine analyzer is for use in professional facilities and centralized
laboratory locations. The analyzer is intended for use in screening at-risk patients
to assist diagnosis in the following areas:
• Kidneyfunction
• Urinarytractinfections
• Metabolicdisorders
• Carbohydratemetabolism
• Liverfunction