(42 days)
The K-ASSAY Transferrin Assay is intended to be used for the quantitative determination of Transferrin in human serum by immunoturbidimetric assay. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia. FOR IN VITRO DIAGNOSTIC USE.
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The provided document (K993537) is a 510(k) clearance letter for the K-ASSAY Transferrin device, which is an in vitro diagnostic assay. It does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner typically described for AI/ML medical devices.
Instead, this document grants clearance based on substantial equivalence to a predicate device. The information provided is primarily regulatory in nature, indicating that the FDA has reviewed the manufacturer's submission and determined the device can be legally marketed.
Therefore, I cannot directly extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, etc.) from this document because it is not present. The questions you've asked are typically addressed in a clinical or performance study report, which would be part of the 510(k) submission but is not included in the clearance letter itself.
To answer your questions, one would need to access the actual 510(k) submission (K993537) and look for the performance data section, which is not publicly available in this format.
Based on the provided text, I can only state that this document does not contain the requested information about acceptance criteria and performance studies in the context of an AI/ML device.
§ 866.5880 Transferrin immunological test system.
(a)
Identification. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.(b)
Classification. Class II (performance standards).