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U.S. Department of Health and Human Services

Product Classification

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Device test, alpha fetoprotein l3 subfraction (afp-l3%), for hepatocellular carcinoma risk assessment
Regulation Description AFP-L3% immunological test system.
Definition In vitro diagnostic test intended as a risk assessment test for the development of hepatocellular carcinoma (hcc) in patients with chronic liver diseases (cld).Elevated afpl3% values (= 10%) have been shown to be associated with a nine-fold increase in the risk of developing hcc in the next 6-12 months.Patients with elevated serum afpl3% should be more intensely evaluated for evidence of hcc according to the existing hcc practice guidelines in oncology.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeNSF
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.6030
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Class II Special Controls Guidance Document: AFP-L3% Immunological Test Systems [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm078096.htm] 
Third Party Review Not Third Party Eligible
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