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The EasyRA µALB reagent is intended for the quantitative determination of micro-albumin in human urine, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Micro-albumin measurements using immunological tests aid in the diagnosis of kidney diseases.

The EasyRA micro-albumin (µALB) calibrator facilitates measurements of µALB on the EasyRA clinical chemistry analyzer when used in conjunction with Medica's µALB reagent. The µALB calibrator is used to establish points of reference that are used in the determination of values in the measurement of µALB in human urine.

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The provided text is a 510(k) summary for a medical device called "EasyRA micro-albumin (uALB) Reagent and EasyRA microalbumin (uALB) Calibrator." It describes the intended use of the device and confirms its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is primarily a regulatory clearance letter.

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