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The Diazyme Ferritin Assay is for the quantitative determination of ferritin in human serum. K2EDTA plasma, and lithium heparin plasma on Hitachi 917 analyzer. For in vitro diagnostic use only.

The Diazyme Ferritin Calibrator Set is intended for use in the Diazyme Ferritin Assay. For in vitro diagnostic use only.

The Diazyme Ferritin Control Set is intended for use as quality controls for the Diazyme Ferritin Assay. For in vitro diagnostic use only.

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The provided text describes a 510(k) premarket notification for a medical device, the Diazyme Ferritin Assay. It primarily focuses on the FDA's determination of substantial equivalence to a predicate device and general regulatory information.

The document does NOT contain information about acceptance criteria, device performance, an actual study proving device performance, sample sizes for test sets or training sets, data provenance, expert qualifications, ground truth establishment, adjudication methods, or MRMC studies.

Therefore, I cannot fulfill your request for that specific information based on the provided text. The document is a regulatory approval letter, not a scientific study report.

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