Performance Evaluation of In-Vitro Diagnostic Device
Performance Evaluation of In-Vitro Diagnostic Device
This is an interim report for POC testing of skyla Clinical Chemistry Analyzer and four skyla
 Test Systems (ALB, BUN, GLU, and TP). The analyses are performed with skyla Clinical
 Chemistry Analyzer.

 Analyte Principle:

 Albumin (ALB) - Dye-Binding BCG

 Blood urea nitrogen (BUN) - Urease with GLDH (coupled enzyme)

 Glucose (GLU) - Hexokinase, Colorimetry

 Total Protein (TP) - Biuret
Inclusion Criteria:

 -  You must be an adult over 20 years of age and weigh over 50 kg to be eligible to
 participate in the study.

 Exclusion Criteria:

 -  You may not participate in this study if you do not meet the above inclusion criteria.