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This kit is intended for the quantitation of kappa free light chains in serum and urine on Binding Site SPApLus. Measurement of free light chains in serum aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinaemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. Measurement of free light chains in urine aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinaemia, AL amyloidosis and light chain deposition disease in conjunction with other laboratory and clinical findings.

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This FDA 510(k) clearance letter pertains to an in vitro diagnostic (IVD) device, the Freelite® Human Kappa Free Kit for use on the SPAPLUS, which quantifies kappa free light chains in serum and urine. The document does not contain the detailed study results, acceptance criteria, or performance data typically found in a clinical study report or a more comprehensive FDA submission.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the provided text. The document itself is a notification of substantial equivalence and does not delve into the specifics of the studies performed to demonstrate that equivalence.

The information sought in your request (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in this regulatory correspondence. This letter confirms that The Binding Site Group, Ltd. can market the device, but it doesn't detail the underlying performance studies.

To get the information you are requesting, one would typically need access to the full 510(k) submission or associated clinical validation studies that the FDA reviewed to make its determination of substantial equivalence.

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