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The Scantibodies Laboratory, Inc. Whole Parathyroid Hormone (PTH) test system is a device intended to measure parathyroid hormone in plasma. PTH measurements are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.

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This document is a marketing approval letter from the FDA for a medical device called "Whole PTH ImmunoChemiluminoMetric (ICMA)." It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about:

• Acceptance criteria or reported device performance.
• The study that proves the device meets acceptance criteria.
• Sample sizes for test or training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested information based on the given input. This document is solely an FDA approval letter and does not include the technical details of the device's validation studies.

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