(430 days)
Human IgA CSF Kit for use on SPAPLUS is intended for the quantitative measurement of human IgA 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 document is a 510(k) clearance letter from the FDA for a medical device called "Human IgA CSF Kit for Use on SPAplus". It does not contain information about acceptance criteria or a study proving the device meets those criteria.
The letter confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, based on its intended use for the quantitative measurement of human IgA in cerebrospinal fluid (CSF) samples using the SPAPLUS analyzer to aid in assessing the body's ability to resist infectious disease.
Therefore, I cannot provide the requested information from the given text.
§ 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).