(130 days)
Hevylite Human IgA Kappa is a quantitative in vitro assay performed on the Binding Site SPAPLUS 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 IgA Kappa / IgA Lambda ratio. The Hevylite Human IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients 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.
Hevylite Human IgA Lambda is a quantitative in vitro assay performed on The Binding Site SPAPLUS for the measurement of IgA Lambda (IgA heavy chain and Lambda light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgA Lambda is used alongside Hevylite Human IgA Kappa to calculate the IgA Kappa / IgA Lambda ratio. The Hevylite Human IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients 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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The provided text is a 510(k) premarket notification letter from the FDA, along with the device's Indications for Use. It describes a diagnostic device, the Hevylite Human IgA Kappa Kit and Hevylite Human IgA Lambda Kit, which are quantitative in vitro assays performed on the Binding Site SPAPLUS for measuring IgA Kappa and IgA Lambda in serum. These measurements are used to calculate the IgA Kappa/IgA Lambda ratio for monitoring previously diagnosed IgA multiple myeloma patients.
This document does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods), or comparative effectiveness studies. It primarily focuses on the regulatory aspects of the device's clearance.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The requested information is typically found in the accompanying technical documentation, such as the 510(k) summary or detailed clinical study reports, which are not present here.
§ 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).