(134 days)
This kit is intended for the quantitation of lambda free light chains in serum and urine on the Roche Hitachi 911 and Hitachi 912. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myelomas, lymphocytic neoplasms, Waldenstrom's macroglobulinemia and connective tissue diseases, such as systemic lupus erythematosus.
Not Found
I am sorry, but the provided text from the FDA 510(k) summary (Re: K023131) does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets those criteria.
The document is a clearance letter from the FDA, stating that "FREELITE Human Lambda Free Kit for Use on the Hitachi 911/912 Analyzer" is substantially equivalent to a legally marketed predicate device. It defines the indications for use but does not detail the performance metrics, study design, or results that would demonstrate the device's accuracy or efficacy.
Therefore, I cannot provide a table of acceptance criteria, reported performance, sample sizes, expert details, adjudication methods, MRMC study results, standalone performance, or training set details based on the information given. This type of information would typically be found in the 510(k) submission itself or a more detailed performance study report.
§ 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).