(522 days)
This kit is intended for the in vitro quantification of IgA Kappa (combined a heavy and k light chain) concentration in human serum on the Siemens Behring Nephelometer™ II (BN™ II). The test result is to be used with previously diagnosed IgA multiple myeloma, in conjunction with other clinical and laboratory findings.
This kit is intended for the in vitro quantification of IgA Lambda (combined a heavy and À light chain) concentration in human serum on the Siemens Behring Nephelometer™ II (BN™ II). The test result is to be used with previously diagnosed IgA multiple myeloma, in conjunction with other clinical and laboratory findings.
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The provided text is a 510(k) premarket notification acceptance letter for diagnostic kits, not a study describing the acceptance criteria and performance of an AI-powered device. Therefore, I cannot extract the requested information as it is not present in the document.
The document pertains to the Hevylite™ Human IgA Kappa Kit and Hevylite™ Human IgA Lambda Kit for use on Siemens BN™ II systems, which are in vitro diagnostic devices for quantifying IgA Kappa and IgA Lambda concentrations in human serum. These are laboratory assay kits, not AI-powered devices.
To answer your request, I would need a document detailing a study on an AI-powered device, including its acceptance criteria and performance evaluation.
§ 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).