Product Classification

• Device: igal heavy & light chain combined
• Regulation Description: Immunoglobulins A, G, M, D, and E immunological test system.
• Definition: Intended for the in-vitro quantification of iga lambda concentration in human serum. The result is to be used with previously diagnosed iga multiple myeloma, in conjunction with other clinical and laboratory findings. For previously diagnosed iga multiple myeloma patients.
• Physical State: The kit is composed of polyclonal monospecific sheep Anti-IgA Lambda antibody, IgA Lambda Calibrator, 2 IgA Lambda Controls, and IgA Lambda Supplementary Reagent
• Technical Method: Nephelometric method
• Target Area: Blood serum
• Regulation Medical Specialty: Immunology
• Review Panel: Immunology
• Product Code: OPY
• 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