(431 days)
Human IgM CSF kit for use on SPAPLUS is intended for the quantitative measurement of human IgM 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
The provided document is a 510(k) premarket notification letter from the FDA to The Binding Site Group Ltd. regarding their "Human IgM CSF Kit for Use on SPAplus." This document primarily addresses the FDA's "substantial equivalence" determination for the device, and does not contain the detailed information about acceptance criteria, specific study design elements (like sample size for test/training sets, experts, adjudication methods, or MRMC studies), or the ground truth establishment that would be present in a comprehensive study report or a 510(k) submission summary itself.
Therefore, I cannot extract the requested information from the provided text. The document is a regulatory approval letter, not a scientific study report.
To provide the requested details, a different document, such as the actual 510(k) submission summary or a performance study report, would be needed.
§ 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).