Performance Evaluation of In-Vitro Diagnostic Device
NCT02894762 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 120
Last updated 2016-09-09
Summary
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
Conditions
- Blood Routine Examination
Sponsors & Collaborators
-
Lite-On Technology Corporation H.S.P.B
lead INDUSTRY
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-01-31
- Primary Completion
- 2017-12-31
Countries
- Taiwan
Study Locations
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