NSF

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

Device class

Class II (moderate risk)

Regulation

21 CFR 866.6030

Medical specialty

Immunology

Flags

Third-party review eligible

FDA 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.

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