(311 days)
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.
Not Found
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.
§ 866.5550 Immunoglobulin (light chain specific) immunological test system.
(a)
Identification. An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.(b)
Classification. Class II (performance standards).