Product Classification

• Device: adalimumab assay
• Definition: An in vitro diagnostic device intended for the measurement of adalimumab, an anti-tumor necrosis factor alpha monoclonal antibody
• Physical State: Solid, dry reagent pack liquid reagents and liquid control solutions
• Technical Method: Time-resolved fluorescence energy transfer immunoassay
• Target Area: Serum
• Regulation Medical Specialty: Toxicology
• Review Panel: Toxicology
• Product Code: QYD
• Premarket Review: Division of Chemistry and Toxicology Devices (DCTD); Division of Chemistry and Toxicology Devices (DCTD)
• Submission Type: 510(k)
• Regulation Number: 862.3115
• 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?: No

Third Party Review

Not Third Party Eligible