(105 days)
This kit is intended for quantifying human IgG subclasses 1, 2, 3 and 4 immunoglobulins in serum on the Olympus AU series analysers. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Not Found
This document is a 510(k) clearance letter from the FDA for an IVD device, the "Binding Site Human IgG Subclass Kit for use on the Olympus AU Series of Instruments." It does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement, as this is typically found in the 510(k) summary or full submission.
Therefore, I cannot extract the requested information from the provided text. The document confirms that the device has been cleared based on substantial equivalence to a predicate device, but it does not detail the specific studies or performance metrics used to establish that equivalence.
§ 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).