Product Classification

• 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 Code: PDE
• Premarket Review: Office of In Vitro Diagnostics (OHT7); 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 Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc