NSF

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

Product code

NSF

Device name

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

Device class

Class 2

21 CFR

21 CFR 866.6030

Medical specialty

Immunology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).