Product Classification

• Device: des-gamma-carboxy-prothrombin (dcp), risk assessment, hepatocellular carcinoma
• Regulation Description: AFP-L3% immunological test system.
• Definition: The test is intended to quantitatively measure dcp in human serum and use as an aid in the risk assessment of patients with chronic liver disease for progression to hepatocellular carcinoma (hcc) in conjunction with other laboratory findings, imaging studies and clinical assessment for risk assessment of patients with chronic liver disease for progression to hepatocellular carcinoma.
• Physical State: An assay kit containing specific antibodies, substrates and reaction columns
• Technical Method: Immunochemical liquid-phase binding assay
• Target Area: peripheral blood
• Regulation Medical Specialty: Immunology
• Review Panel: Immunology
• Product Code: OAU
• Premarket Review: Division of Immunology and Hematology Devices (DIHD); Division of Immunology and Hematology Devices (DIHD)
• Submission Type: 510(k)
• Regulation Number: 866.6030
• 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