(62 days)
Hevylite Human IgA Kappa is a quantitative in vitro assay performed on the Siemens BN II nephelometer for the measurement of IgA Kappa (IgA heavy chain and Kappa light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgA Kappa is used alongside Hevylite Human IgA Lambda to calculate the JgA Kappa / IgA I levylite I luman IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple mycloma and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunotixation. bone marrow and urine assessments.
Hevylite Human IgA Lambda is a quantiative in vitro assy performed on the Siemens IN II nepheloment of IgA Lambda (IgA heavy chain and Lambda light chain intact immunoglobulin) in scrum. Mcasurement of Hevylite Human IgA Lambda is used alongside Hevylite Human IgA Kappa to calculate the IgA Lamburratio. The Hevylite Human IgA Kappa / 12A Lambda ratio can be used when monitoring previously diagnosed lgA multiple mycloma and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.
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This document is a 510(k) clearance letter from the FDA for two in-vitro diagnostic devices: the Hevylite™ Human IgA Kappa Kit and the Hevylite™ Human IgA Lambda Kit, both for use on Siemens BN™ II Systems. The letter states that the devices are substantially equivalent to legally marketed predicate devices.
The "Indications for Use" section on page 3 describes the purpose of these devices:
- Hevylite Human IgA Kappa is a quantitative in vitro assay for the measurement of IgA Kappa (IgA heavy chain and Kappa light chain intact immunoglobulin) in serum.
- Hevylite Human IgA Lambda is a quantitative in vitro assay for the measurement of IgA Lambda (IgA heavy chain and Lambda light chain intact immunoglobulin) in serum.
Both kits are used to calculate the IgA Kappa/IgA Lambda ratio or IgA Lambda/IgA Kappa ratio, respectively, for monitoring previously diagnosed IgA multiple myeloma, in conjunction with other laboratory tests and clinical evaluations. They are not to be used alone for the assignment of complete response, which requires other tests like immunofixation, bone marrow, and urine assessments.
While the document details the intended use and regulatory clearance, it does not contain the specific acceptance criteria for performance, nor does it describe a study proving the device meets acceptance criteria with the requested details (sample sizes, ground truth establishment, expert qualifications, etc.). This document confirms the device's clearance based on substantial equivalence, but it does not present the underlying performance study data.
Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria and the study that proves the device meets them because that information is not provided in the supplied text. The document is an FDA clearance letter, not a detailed study report.
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).