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This kit is intended for the quantitation of kappa free light chains in serum on The Binding Site SpaPlus. 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 erythematosus in conjunction with other laboratory and clinical findings.

This kit is intended for the quantitation of lambda free light chains in serum on The Binding Site SpaPlus. 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 erythematosus in conjunction with other laboratory and clinical findings.

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I am sorry, but the provided document does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, ground truth establishment, or details of any studies (like MRMC or standalone studies). The document is an FDA 510(k) clearance letter for two kits (FREELITE Human Kappa Free Kit and FREELITE Human Lambda Free Kit) and their indications for use, but it does not include the technical study details requested.

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