An Immunoglobulin (Light Chain Specific) Immunological Test System is a diagnostic system used to detect and quantify free light chains (kappa and lambda) in biological samples, typically serum or urine. This test helps in diagnosing and monitoring disorders related to abnormal immunoglobulin production, such as multiple myeloma, monoclonal gammopathy of undetermined significance (MGUS), and light chain amyloidosis.

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 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.

Intended use.

This is an in vitro diagnostic Immunological Test System Intended for the quantitative measurement of free Kappa (Κ) Immunoglobulin light chains in human serum and/or plasma. The device is used as an aid in the diagnosis and monitoring of diseases associated with abnormal free kappa light chain production, including plasma cell dyscrasias such as multiple myeloma, light chain amyloidosis, Waldenström’s macroglobulinemia, and related monoclonal gammopathies. Results are intended to be interpreted in conjunction with other clinical findings and laboratory tests.

Device Description

The DFH device consists of light chain–specific immunoassay reagents designed to selectively detect free kappa immunoglobulin light chains in human specimens. The system typically includes kappa-specific antibodies, calibrators, controls, and assay buffers, supplied as a reagent kit for use on automated or semi-automated clinical laboratory analysers. The assay is based on established antigen–antibody reaction principles (such as immunoturbidimetric or immunonephelometric techniques), where immune complex formation generates a measurable signal proportional to the concentration of free kappa light chains present in the sample. The device is intended for use by trained laboratory professionals in a clinical laboratory environment.

Lambda, Antigen, Antiserum, Control

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 device is used as an aid in the diagnosis and monitoring of disorders associated with abnormal free lambda light chain production, including plasma cell dyscrasias such as multiple myeloma, light chain amyloidosis, Waldenström’s macroglobulinemia, and other monoclonal gammopathies. Test results are intended to be used together with clinical evaluation and other laboratory findings.

Device Description

The device comprises Lambda-Specific Immunological Reagents designed to selectively bind and quantify Free Lambda Immunoglobulin Light Chains in human specimens.
The device is typically provided as a reagent kit containing lambda-specific antibodies, calibrators, controls, and associated buffers, for use on compatible clinical chemistry or immunoassay analysers. The measurement principle is based on specific antigen–antibody interactions, where immune complex formation produces an optical signal that correlates with the concentration of free lambda light chains in the sample.
The device is intended for professional use in clinical laboratories as part of the evaluation and monitoring of plasma cell disorders.

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

• Analytical Sensitivity
• Linearity & Measuring Range
• Precision
• Method Comparison
• Specificity/Interference
• Hook Effect Testing
• Reagent Stability
• Limit of Blank (LoB) / Limit of Detection (LOD) / Limit of Quantitation (LoQ)
• Traceability, Stability, Expected Values (Controls, Calibrators, or Methods)
• Assay cut-off.
• Matrix comparison

Clinical studies:

No Guidance available for 510k submission