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U.S. Department of Health and Human Services

Product Classification

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Device immunoglobulin g lambda 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 IgG lambda concentration in human serum. The result is to be used with previously diagnosed IgG multiple myeloma, in conjunction with other clinical and laboratory findings.
Physical State Kit is composed of polyclonal monospecific sheep anti-IgG lambda antibody, IgG lambda Calibrator, 2 IgG lambda Controls, and IgG lambda Supplementary Reagent
Technical Method Nephelometric immunoassay method
Target Area Blood serum
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodePCO
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