(60 days)
The K-ASSAY IgA Assay is intended to be used for the quantitative determination of IgA in human serum by immunoturbidimetric assay. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. FOR IN VITRO DIAGNOSTIC USE.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "K-ASSAY IgA". It indicates that the device has been found substantially equivalent to a legally marketed predicate device. This type of document does not contain the detailed study information, acceptance criteria, or performance data that your request asks for.
The letter focuses on regulatory approval and mentions the intended use of the device: "The K-ASSAY IgA Assay is intended to be used for the quantitative determination of IgA in human serum by immunoturbidimetric assay. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. FOR IN VITRO DIAGNOSTIC USE."
Therefore, I cannot provide the specific information requested about acceptance criteria and study details from the provided text. To obtain that information, you would typically need to refer to the original 510(k) submission summary or detailed study reports, which are not included in this FDA clearance letter.
§ 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).