(57 days)
The K-ASSAY IgM Assay is intended to be used for the quantitative determination of lgM in human serum by immunoturbidimetric assay. Measurement of IgM 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 for the K-ASSAY IgM device, which is an in vitro diagnostic device. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter from the FDA (Food and Drug Administration) states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics, and is therefore considered safe and effective. However, it does not describe the specific performance studies or acceptance criteria that would have been used to establish this substantial equivalence.
Therefore, I cannot provide the requested information based on the provided text. The document is primarily an administrative clearance notice, not a detailed performance study report.
§ 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).