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U.S. Department of Health and Human Services

Product Classification

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Device immunoglobulin m kappa heavy and light chain combined
Regulation Description Immunoglobulins A, G, M, D, and E immunological test system.
Definition Intended for the in-vitro quantification of IgM kappa concentration in human serum. The result is to be used with previously diagnosed igm Waldenstoms Macrolobulinaemia, in conjunction with other clinical and laboratory findings.
Physical State Kit is composed of polyclonal monospecific sheep anti-IgM kappa antibody, IgM kappa Calibrator, 2 IgM kappa Controls, and IgM kappa Supplementary Reagent
Technical Method Nephelometric immunoassay method
Target Area Human peripheral blood, serum
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodePDE
Premarket Review Division of Immunology and Hematology Devices (DIHD)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 866.5510
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons