Product Classification

• Device: tyrosine phosphatase (ia-2) autoantibody assay
• Regulation Description: Multiple autoantibodies immunological test system.
• Definition: The device is used for the semi-quantitative determination of autoantibodies against tyrosine phosphatase (IA-2) in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes).
• Physical State: n/a
• Technical Method: Radioimmunoassay
• Target Area: n/a
• Regulation Medical Specialty: Immunology
• Review Panel: Immunology
• Product Code: OIF
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Immunology and Hematology Devices (DIHD)
• Submission Type: 510(k)
• Regulation Number: 866.5660
• 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