Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment
The Alpha Fetoprotein L3 Subfraction (AFP-L3%) Test for Hepatocellular Carcinoma Risk Assessment is an in vitro diagnostic test intended to assess the risk of developing hepatocellular carcinoma (HCC) in patients with chronic liver diseases. Elevated AFP-L3% values of 10% or greater have been associated with a nine-fold increased risk of developing HCC within 6 to 12 months, and patients with elevated results should be more intensely evaluated according to existing HCC practice guidelines. It is an FDA Class 2 device regulated under 21 CFR 866.6030 in the Immunology specialty, with product code NSF, requiring 510(k) clearance and eligible for third-party review. It is not an implant and does not carry a life-sustaining support flag.
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Basic Information
- Product Code
- NSF
- Device Class
- FDA class 2
- Regulation Number
- 866.6030
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K100464 | UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION | Feb 23, 2011 | Substantially Equivalent | Wako Chemicals USA, Inc. |
| DEN050002 | LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS | May 19, 2005 | Unknown | Wako Chemicals USA, Inc. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.