NSF · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.6030
Classification
FDA Product Code
NSF
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.6030
Review panel
IM
Medical specialty
Immunology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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.