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This kit is intended for the quantitation of kappa free light chains in serum and urine on the Dade Behring Nephelometer II (BNII). Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythemoatosus.

This kit is intended for the quantitation of lambda free light chains in serum and urine on the Dade Behring Nephelometer II (BNII). Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythemoatosus.

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I am sorry, but the provided text from the FDA 510(k) letter does not contain information about acceptance criteria for device performance or a study proving that the device meets such criteria. This document is primarily an FDA clearance letter for a medical device (FREELITE® Human Kappa Free Kit and FREELITE® Human Lambda Free Kit) regarding its substantial equivalence to a legally marketed predicate device.

The letter confirms that the device can be marketed subject to general controls and specifies the regulation number, regulation name, and product codes. It also includes the "Indications for Use" for both kits, but it does not detail any performance metrics, studies, sample sizes, expert involvement, or adjudication methods that would be required to answer your specific questions.

Therefore, I cannot provide the requested information based on the given input.

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