(62 days)
An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis and chronic renal disease. For the quantitative determination of iron in serum and heparinized plasma. For IN VITRO diagnostic use.
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I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding the "Iron-PC-SL Assay." This document primarily focuses on the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.
The information requested in your prompt, such as specific acceptance criteria and the details of a study proving the device meets those criteria, including sample sizes, ground truth establishment, MRMC studies, or standalone performance, is not present in this type of regulatory correspondence.
This document confirms the device's classification and its ability to be marketed, but it does not contain the technical study details you are asking for. A typical 510(k) submission would include such studies, but the letter itself is just the FDA's response.
§ 862.1410 Iron (non-heme) test system.
(a)
Identification. An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.