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The K-ASSAY® Ferritin (2) assay is an in vitro diagnostic reagent for the quantitative determination of ferritin (an iron-storing protein) in human serum and plasma by immunoturbidimetric assay on the Roche / Hitachi 917 analyzer. Measurements of ferritin aid in the diagnosis of diseases affecting iron overload and iron deficiency anemia. For in vitro diagnostic use.

The K-ASSAY® Ferritin Calibrator Set is an in vitro diagnostic reagent for calibration of the K-ASSAY® Ferritin (2) Assay.

For in vitro diagnostic use.

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This document is a 510(k) clearance letter from the FDA for a medical device, specifically an in-vitro diagnostic test. It confirms that the device is substantially equivalent to a legally marketed predicate device.

Crucially, this document does not contain the acceptance criteria, study details, or performance data of the device.

The letter states that the FDA has reviewed the premarket notification, but it does not present the data from the studies that would have been submitted as part of that notification.

Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample sizes, ground truth details, MRMC study results, etc.) from the provided text. This information would typically be found in the 510(k) submission itself or a separate performance study report, which is not included here.

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