(53 days)
This kit is intended for the quantitation of kappa free light chains in serum on the Bayer Advia® 1650. 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.
Not Found
This is an interesting request, but the provided text is a 510(k) clearance letter from the FDA. It approves a medical device for marketing based on substantial equivalence to a predicate device.
Crucially, this document does NOT contain a study description, acceptance criteria, or performance data for the device (FREELITE™ Human Kappa Free kit for use on the Bayer ADVIA® 1650 and FREELITE™ Human Lambda Free kit for use on the Bayer ADVIA® 1650).
The letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
This means the FDA found the new device to be as safe and effective as devices already on the market, usually by comparing its specifications and performance to a "predicate" device. The detailed studies and data proving this equivalence are typically submitted as part of the 510(k) application, but they are not included in the clearance letter itself.
Therefore, I cannot fulfill your request using the provided text. To answer your questions, I would need the actual study report or the performance data submitted by The Binding Site, LTD. as part of their 510(k) submission.
§ 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).