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The EasyRA Creatinine (CREA) Reagent is for the measurement of creatinine in serum and plasma using the "EasyRA chemistry analyzer". Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis. For in vitro diagnostic use only.

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The provided document is an FDA 510(k) clearance letter for the EasyRA Creatinine Reagent. It states that the device is substantially equivalent to a predicate device for measuring creatinine in serum and plasma.

However, this document does not contain the specific information required to answer your request about acceptance criteria and study details. The 510(k) clearance letter itself is a summary of the FDA's decision, not the full submission that would detail the performance studies and acceptance criteria.

To answer your questions, one would need access to the actual 510(k) premarket notification submission for K123586, which would include the performance data and the study design.

Therefore, I cannot provide the requested table and study details based solely on the provided text. The document confirms the device's indications for use: "The EasyRA Creatinine (CREA) Reagent is for the measurement of creatinine in serum and plasma using the "EasyRA chemistry analyzer". Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis." but does not elaborate on the performance characteristics or the studies conducted to establish substantial equivalence.

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