(140 days)
Hevylite Human IgM Kappa kit for use on SPAPLUS is intended for the in-vitro quantification of IgM kappa (combined u heavy and k light chain) concentration in human serum on the Binding Site SPAPLUS. The test result is to be used with previously diagnosed Waldenström's macroglobulinaemia in conjunction with other clinical findings. This assay has not been established for the diagnosis of Waldenstrom's macroglobulinaemia.
Hevylite Human IgM Lambda kit for use on SPAPLUS is intended for the in-vitro quantification of IgM lambda (combined u heavy and A light chain) in human serum on the Binding Site SPAPLUS. The test result is to be used with previously diagnosed Waldenstrom's macroglobulinaemia. The test result is to be used in conjunction with other clinical findings.
This assay has not been established for the diagnosis, monitoring and prognosis of Waldenström's macroglobulinaemia.
Evaluating the concentration of a soluble antigen (e.g. IgM Kappa and IgM Lambda) by turbidimetry involves the addition of the test sample to a solution containing the appropriate antibody (anti-IgM kappa and anti-IgM lambda) in a reaction vessel or cuvette. A beam of light id passed through the cuvette and, as the antigen-antibody reaction proceeds, the light passing through the cuvette is scattered increasingly as insoluble immune complexes are formed. Light scatter is monitored by measuring the decrease in intensity of the incident beam of light. The antibody in the cuvette is in excess so the amount of immune complex formed is proportional to the antigen concentration. A series of calibrators of known antigen concentration are assayed initially to produce a calibration curve of measured light scatter versus antigen concentration. Samples of unknown antigen concentration can then be assayed and the results read from the calibration curve.
This document describes the Hevylite Human IgM Kappa Kit for use on SPAPLUS and the Hevylite Human IgM Lambda Kit for use on SPAPLUS, which are in-vitro quantification assays for IgM kappa and IgM lambda concentrations in human serum. The primary study presented is a substantial equivalence comparison to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily linked to its analytical performance, specifically precision, linearity, and agreement with the predicate device. The document explicitly states acceptance criteria for repeatability, reproducibility, linearity (recovery and CV), and agreement with the predicate.
| Performance Metric | Acceptance Criteria | Reported Device Performance (Hevylite IgM Kappa / IgM Lambda on SPAPLUS) |
|---|---|---|
| Precision/Reproducibility | ||
| Total %CV (Repeatability) |
§ 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).