An Immunoglobulin (Light Chain Specific) Immunological Test System is a medical device used to measure the levels of specific types of immunoglobulin light chains (kappa and lambda) in a patient’s blood or other bodily fluids, allowing for the detection of abnormal ratios which can indicate potential diseases like multiple myeloma, where the body produces an excessive amount of one type of light chain protein.

Intended Use Of Immunoglobulin (Light Chain Specific) Immunological Test System

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 is 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.

Intended Use:

The device is an in vitro diagnostic immunological test system intended for the quantitative measurement of free lambda (λ) immunoglobulin light chains in human serum and/or plasma. The measurement of free lambda light chains is used as an aid in the diagnosis and monitoring of disorders associated with abnormal immunoglobulin light chain production, including but not limited to plasma cell dyscrasias such as multiple myeloma, light chain amyloidosis, Waldenström’s macroglobulinemia, and related monoclonal gammopathies. Test results are intended to be interpreted in conjunction with clinical findings and other laboratory data.

Device Description:

Device consists of immunoassay reagents and associated components designed to selectively detect and quantify free lambda immunoglobulin light chains (λ FLC) in human serum or plasma using immunochemical methods on automated or semi-automated clinical laboratory analyzers.

Core Components

• Reagents
• Calibrators
• Controls
• Buffers and Diluent Solutions

Performance Testing (Analytical-Nonclinical) for Immunoglobulin (Light Chain Specific) Immunological Test System

• Precision/Reproducibility
• Assay Cutt Off
• Analytical Specificity
• Traceability (Controls, Calibrators, Or Method)
• Interference
• Analytical Sensitivity

Clinical Testing:

No Guidance available for 510k submission