(431 days)
Human IqG CSF Kit for use on SPAPLUS is intended for the quantitative measurement of human IgG in cerebrospinal fluid (CSF) samples using the SPAPLUS analyser. Measurement of this immunoglobulin aids in the assessment of the body's lack of ability . to resist infectious disease in conjunction with other clinical and laboratory findings.
Not Found
This is a 510(k) clearance letter from the FDA for a diagnostic kit, not a study evaluating an AI/ML device. Therefore, the requested information regarding acceptance criteria, study design, expert involvement, and AI performance metrics is not applicable and cannot be extracted from this document.
The document describes a "Human IgG CSF Kit for Use on SPAplus" which is intended for the quantitative measurement of human IgG in cerebrospinal fluid (CSF) samples. The FDA has determined this device is "substantially equivalent" to legally marketed predicate devices. This type of clearance does not involve clinical studies with human readers or AI algorithms as the primary subject of evaluation in the way your prompt describes.
§ 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).