Product Classification

• Device: aquaporin-4 autoantibody
• Definition: For the determination of autoantibodies to Aquaporin-4 in human serum and plasma. The test may be useful as an aid in the diagnosis of Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorders (NMOSD). The test is not to be used alone and is to be used in conjunction with other clinical and radiological (MRI) laboratory findings.
• Physical State: Calibrators, Controls, and Assay Reagents
• Technical Method: Immunological detection of autoantibodies using capture antigen immobilized on solid surface and labeled secondary antibody
• Target Area: Whole blood, Plasma, and Serum
• Regulation Medical Specialty: Immunology
• Review Panel: Immunology
• Product Code: PNI
• Premarket Review: Division of Immunology and Hematology Devices (DIHD); Division of Immunology and Hematology Devices (DIHD)
• Submission Type: 510(k)
• Regulation Number: 866.5665
• 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
• sgs north america