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The concentration of calcium is determined by the balance between absorption in the intestine and excretion in the kidneys and by exchanges between plasma, extracellular fluid and tissues including bone. Diseases associated with hypercalcemia include primary hyperthyroidism and hypercalcemia of malignancy. Hypocalcemia is associated with hypoparathyroidism and pseudohypoparathyroidism, vitamin D deficiency, hereditary vitamin D dependency, rickets types I and II, and intestinal malabsorption.1 Many methods exist for determining calcium. The o-cresophthalein complexone method remains popular in the clinical laboratory because performing it is fast and easy. The arsenazoIII method is a relatively new single reagent method. It is rapidly gaining popularity because it is even easier to use and has virtually no magnesium interference even at levels as high as 20 mg/dL.2 Further modifications to the method, in conjunction with sample blanking on the SYNCHRON CX 3 System, have resulted in a rapid calcium test with increased specificity. Both calcium reagents are used to measure calcium concentrations in serum, plasma, or urine on the SYNCHRON CX 3 System, and the reaction principles for both are identical.

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This is a 510(k) summary for a reagent, not an AI-powered diagnostic device. Therefore, many of the requested fields related to AI/ML device evaluation, such as sample sizes for test and training sets, expert ground truth, adjudication methods, and MRMC studies, are not applicable.

Here's an analysis based on the provided text, focusing on the equivalence study performed for this reagent:

Acceptance Criteria and Device Performance:

The primary acceptance criteria for the Sigma Diagnostics CX®-3 Calcium Reagent are demonstrated by its substantial equivalency to the Beckman Calcium Reagent Kit. This equivalency is assessed through correlation and precision studies.

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