CHAPTER 1. UNDERSTANDING THE NEW ANALYZER
1.
Indication for use; purpose of the analyzer
The SD LipidoCare Professional Analyzer is intended to be used by individuals in the
Professional to measure total cholesterol (TC), triglycerides (TG), HDL cholesterol (HDL), and
glucose in capillary whole blood with the SD LipidoCare Professional Lipid Profile Test Strips and
SD LipidoCare Professional Blood Glucose Test Strips; it is also intended to calculate low density
lipoprotein (LDL), the LDL/HDL ratio, and non-HDL. This analyzer is to be used outside the
body (in vitro diagnostic).
The SD LipidoCare Professional Lipid Profile Test Strips are intended to be used by medical
professionals to measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in
capillary whole blood and venous blood on an SD LipidoCare Professional Analyzer. Cholesterol
measurements are used in the diagnosis and treatment of disorders involving excess cholesterol
in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used
in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis,
and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and
treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases
involving lipid metabolism, or various endocrine disorders. Calculated LDL-cholesterol values are
reported only when triglycerides are ≤400mg/dL; when triglycerides are >400 mg/dL, the
calculated LDL-cholesterol and LDL/HDL (LDL-cholesterol and HDL-cholesterol ratio) are not
reported.
The SD LipidoCare Professional Blood Glucose Test Strips are intended to be used by medical
professionals to measure glucose in capillary whole blood on an SD LipidoCare Professional
Analyzer. Glucose measurement is for the quantitative measurement of the concentration of
glucose in capillary whole blood that can be taken from the fingertip, palm, upper arm, and/or
forearm as an aid in the management of diabetes. Glucose measurement is not to be used for
the diagnosis of or screening for diabetes or neonatal use. Alternate site testing should be done
during steady-state times, when glucose is not changing rapidly.
The SD Lipid Control Solution and SD Glucose Control Solution are used as quality control
materials for the SD LipidoCare Professional System.
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