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The EasyLyte Na/K/C/Ca Analyzer is intended for in-vitro diagnostic testing of sodium (Na), Potassium (K), Chloride (CL), and lonized Calcium (Ca++) without pH correction.

The ionized calcium test on the EasyLyte Na/K/C//Ca analyzer is intended for the quantitative determination of calcium ions (Ca++) in human serum, plasma and whole Blood in clinical laboratories. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone disease and tetany finternittent muscular contractions or spasms).

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The provided text is a 510(k) premarket notification letter from the FDA to MEDICA CORPORATION for their EasyLyte Na/K/Cl/Ca Analyzer. This document primarily focuses on the regulatory aspects of the device, stating that the FDA has determined it is "substantially equivalent" to legally marketed predicate devices.

However, the letter does not contain the detailed study information required to answer your specific questions regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. This type of information would typically be found in the device's 510(k) submission itself, which is a much larger and more technical document than the FDA's regulatory response letter.

Therefore,Based on the provided document, I cannot accurately describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter, which confirms substantial equivalence but does not detail the specific performance studies, acceptance criteria, or their results.

To answer your questions, I would need access to the actual 510(k) submission for K152327, which contains the detailed technical and clinical performance data.

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