Product Classification

• Device: anti-ss-a 52 autoantibodies
• Regulation Description: Antinuclear antibody immunological test system.
• Definition: The device is used for the detection, in human serum or plasma, of autoantibodies to SS-A 52. The detection of SS-A 52 autoantibodies may aid in the diagnosis of systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, polymyositis and dermatomyositis.
• Physical State: The device consist of components/reagents to detect and semi-quantitatively measure autoantibodies to SS-A 52.
• Technical Method: Enzyme-linked immunosorbent assay (ELISA) or enzyme immunoassay (EIA)
• Target Area: The assay is performed by testing human serum or plasma.
• Regulation Medical Specialty: Immunology
• Review Panel: Immunology
• Product Code: OBE
• Premarket Review: Division of Immunology and Hematology Devices (DIHD); Division of Immunology and Hematology Devices (DIHD)
• Submission Type: 510(k)
• Regulation Number: 866.5100
• 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