(47 days)
The Total Iron Binding Capacity (TIBC) reagents, product No. FE109-01, FE109-02 and The Total Iron Binding Capacity (TIDO) reagones processor seni-automated, quantitative determination of TIBC in serum, or plasma.
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This document is a 510(k) clearance letter from the FDA for a Total Iron Binding Capacity (TIBC) device. It confirms the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain the detailed study information required to answer your questions regarding acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment. The document is primarily an FDA regulatory approval letter and an "Indications For Use" statement.
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§ 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.