(31 days)
This kit is intended for quantifying IgG subclasses 1, 2, 3 and 4 immunoglobulins in serum on the BNI. Subcrasses if 2, 3 and innoglobulins aids in the diagnosis of Measurement of chebe immandy ond the body's lack of ability to resist infectious agents.
Human IgG Subclass Liquid Reagent Kits (for use on the Behring BNII Analyser)
The provided text is a 510(k) clearance letter from the FDA for an in vitro diagnostic device, "Human IgG Subclass Liquid Reagent Kits." It does not contain any information about acceptance criteria for a device performance, a study to prove these criteria were met, or any details related to AI/algorithm performance.
Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, not on specific performance metrics or clinical study results as they would be presented for an AI-powered diagnostic device.
§ 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).