Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay

The Diazyme Human Kappa and Lambda Free Light Chain Assays are in vitro diagnostic tests that quantitatively measure free light chain concentrations in serum using a latex particle-enhanced immunoturbidimetric method. These assays aid in the diagnosis and monitoring of multiple myeloma and in the evaluation of monoclonal gammopathy of undetermined significance (MGUS) when used alongside other laboratory and clinical findings.

Both the subject device and predicate use identical latex particle-enhanced immunoturbidimetric technology with polyclonal antibodies coated on polystyrene latex microparticles. No modifications were made to kit components; both measure kappa and lambda free light chains in serum with the same reference intervals, analytical measuring intervals, and detection methodology using internal reference preparations.

Not stated in this summary.

The subject device is substantially equivalent to predicate K211648 because it uses identical assay methodology, reagents, calibrators, and controls with no modifications to kit components. All analytical characteristics including precision, linearity, reportable range, and traceability are the same. The only difference is the addition of MGUS evaluation to the intended use, which is supported by two retrospective clinical studies demonstrating 53.7% positive rate and 94.0% negative rate for MGUS diagnosis, and 100% positive rate and 90.5% negative rate for MGUS monitoring.