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VITROS Ferritin Reagent Pack - For the in vitro quantitative measurement of Ferritin in human serum and plasma (heparin). Measurements of Ferritin aid in the diagnosis of diseases affecting iron metabolism such as hemachromatosis (iron overload) and iron deficiency anemia.

VITROS Ferritin Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of Ferritin in human serum and plasma (heparin)

VITROS Ferritin Controls - For in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the measurement of Ferritin

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This document is a 510(k) clearance letter from the FDA for an in vitro diagnostic device (IVD), specifically for the Vitros™ Immunodiagnostic Products Ferritin Reagent Pack, Calibrators, and Controls. It confirms that the device is substantially equivalent to legally marketed predicate devices.

The letter itself does not contain the acceptance criteria or a detailed study description proving the device meets those criteria. Such information would typically be found in the original 510(k) submission that the FDA reviewed. The letter only states that the FDA has reviewed the submission and found the device substantially equivalent for its stated indications for use.

Therefore,Based on the provided text, I cannot extract the detailed information requested regarding acceptance criteria and the specifics of the study. The document is an FDA clearance letter, not the submission itself where such details would be laid out.

To answer your request, I would need access to the actual 510(k) submission (K973331) for the Vitros™ Immunodiagnostic Products Ferritin Reagent Pack, Calibrators, and Controls. This submission would contain the performance data, acceptance criteria, study design, and details about the test and training sets.

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