Product Classification

• Device: anti-phospholipase a2 receptor
• Definition: The test system is intended for the qualitative determination of IgG class autoantibodies against phospholipase A2 receptor (PLA2R) in human serum. It is used as an aid in the diagnosis of primary membranous glomerulonephritis (pMGN), in conjunction with other laboratory and clinical findings.
• Physical State: slides coated with cells, fluorescein-labelled detection antibody, positive and negative controls, buffers, embedding medium, cover glasses
• Technical Method: indirect immunofluorescence assay (IFA)
• Target Area: serum
• Regulation Medical Specialty: Microbiology
• Review Panel: Immunology
• Product Code: PGV
• Premarket Review: Division of Immunology and Hematology Devices (DIHD); Division of Immunology and Hematology Devices (DIHD)
• Submission Type: 510(k)
• Regulation Number: 866.5780
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: Yes

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

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