Product Classification

• Device: alpha-1-antitrypsin kit, qualitative phenotype
• Regulation Description: Alpha-1-antitrypsin immunological test system.
• Definition: The alpha-1-antitrypsin qualitative phenotype test result is used as an aid in the diagnosis of alpha-1-antitrypsin deficiency in conjunction with clinical and other laboratory findings. For in vitro diagnostic use only.
• Physical State: A1AT Antibody Isoelectric focusing gel qualitative phenotype kit and A1AT qualitative phenotype control
• Technical Method: Isoelectric focusing gel qualitative test.
• Target Area: Blood serum
• Regulation Medical Specialty: Immunology
• Review Panel: Immunology
• Product Code: OBZ
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Immunology and Hematology Devices (DIHD)
• Submission Type: 510(k)
• Regulation Number: 866.5130
• 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

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