(553 days)
This assay is designed for the in vitro measurement of human IgG3 in serum using the MININEH analyzer as measurement of human 1965 in berail ablig one and in the diagnosis of the
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The provided text is a 510(k) clearance letter from the FDA for "IgG and IgG Subclass Nephelometric Diagnostic Test Kits" (Trade Name: Minineph IgG3 Antiserum Device Name). It confirms the device's substantial equivalence to a legally marketed predicate device.
However, this document does not contain the detailed acceptance criteria and study data requested in your prompt.
The letter focuses on regulatory clearance, not the technical specifications, performance data, or study methodologies that would typically be found in a 510(k) summary, clinical study report, or a more comprehensive technical document. It mentions that the device is for "in vitro measurement of human IgG3 in serum using the MININEPH analyzer."
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, reported performance, sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).