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The EasyRA dLDL reagent is intended for the quantitative determination of Low Density Lipoproteins in human serum, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. The LDL Cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

The EasyRA dLDL calibrator facilitates measurements of LDL Cholesterol on the EasyRA clinical chemistry analyzer when used in conjunction with Medica's dLDL reagent. The dLDL calibrator is used to establish a point of reference that is used in the determination of values in the measurement of LDL Cholesterol in human serum.

The EasyRA EasyQC material validates measurements of LDL Cholesterol on the EasyRA clinical chemistry analyzer when used in conjunction with Medica's dLDL reagent and calibrator. The EasyQC is used to estimate test precision and to detect systemic analytical deviations that may arise from reagent or analytical instrument variation.

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This document is a 510(k) premarket notification from the FDA for a medical device called "EasyRA Direct Low Density Lipoproteins Cholesterol Reagent." It specifies the device's indications for use and mentions associated calibrators and quality control materials. However, it does not contain the detailed acceptance criteria or the study results that demonstrate the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval (substantial equivalence) and product labeling, not on the performance study details themselves.

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