(43 days)
The total iron reagents: Buffer, pH 4.5 (R1), product No. FE109-01 and Color reagent, product No. FE109-02 are intended for use in the automated, quantitative determination of Total Iron in serum, or plasma.
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The provided text is a 510(k) premarket notification letter from the FDA regarding the "TOTAL IRON" device. It acknowledges that the device is substantially equivalent to legally marketed predicate devices for the "automated, quantitative determination of Total Iron in serum, or plasma."
However, this letter does not contain any information regarding specific acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment. It is a regulatory approval document based on substantial equivalence, not a detailed scientific study report.
Therefore, I cannot fulfill your request to create a table of acceptance criteria and device performance, or describe the study details using the provided input. This document only states the intended use and regulatory classification.
§ 862.1415 Iron-binding capacity test system.
(a)
Identification. An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.(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.