(242 days)
For the quantitation of kappa free light chains in serum on the Roche COBAS INTEGRA 400 and 400plus. 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.
For the quantitation of lambda free light chains in serum on the Roche COBAS INTEGRA 400 and 400plus. 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
This FDA 510(k) clearance letter dated November 30, 2007, for the "FREELITE™ Human Lambda Free Kit for use on Roche COBAS® INTEGRA 400/400 plus" and "FREELITE™ Human Kappa Free Kit for use on Roche COBAS® INTEGRA 400/400 plus" focuses on establishing substantial equivalence to a legally marketed predicate device.
Crucially, this document does not contain the specific acceptance criteria or detailed study results that demonstrate the device meets those criteria.
The letter confirms that the device is substantially equivalent for the stated indications for use (quantitation of kappa and lambda free light chains in serum to aid in the diagnosis and monitoring of various conditions). However, it does not provide the technical performance data, test methods, or statistical analyses typically found in a study report.
Therefore, I cannot populate the requested table or answer the specific questions regarding sample sizes, ground truth establishment, expert qualifications, or MRMC studies based solely on the provided FDA clearance letter. These details would be contained within the 510(k) submission itself, which is not included here.
To answer your request, I would need access to the full 510(k) submission document, specifically the sections detailing the validation and verification studies.
§ 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).