Search Results

This kit is intended for the qualitative identification of monoclonal gammopathies in urine using protein electrophoresis and immunofixation. This kit could be a useful aid, in conjunction with other medical diagnostic tests, in the diagnosis of various disease states which typically exhibit abnormal patterns. Examples of such gammopathies are multiple myeloma, collagen disorders and other chronic infections.

Not Found

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria, study details, and performance metrics for the SPIFE – Urine Immunofixation Electrophoresis Kit.

The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a legally marketed predicate device. It states the indications for use of the device but does not include:

• A table of acceptance criteria or reported device performance.
• Sample sizes for test or training sets.
• Data provenance.
• Details about expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance.
• The type of ground truth used or how it was established for either test or training sets.

Therefore, I cannot fulfill your request based on the information provided.

Ask a specific question about this device