510(k) DEN050002
DEN050002 is an FDA 510(k) premarket notification submitted by Wako Chemicals USA, Inc. for the device "LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS". The FDA issued a decision of De Novo Granted on May 19, 2005. The device falls under product code NSF (Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment), a Class II device regulated under 21 CFR 866.6030. Wako Chemicals USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 19, 2005
- Date Received
- April 7, 2005
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment
- Device Class
- Class II
- Regulation Number
- 866.6030
- Review Panel
- IM
- Submission Type
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.