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

FDA Device Classification

Classification Details

Product Code
NSF
Device Class
Class II
Regulation Number
866.6030
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K100464wako chemicals usaUTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L,February 23, 2011
DEN050002wako chemicals usaLBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYSMay 19, 2005