Cleared Traditional

UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION

K100464 · Wako Chemicals USA, Inc. · Immunology

Feb 2011

Decision

370d

Days

Class 2

Risk

About This 510(k) Submission

K100464 is an FDA 510(k) clearance for the UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION, a Test, Alpha Fetoprotein L3 Subfraction (afp-l3%), For Hepatocellular Carcinoma Risk Assessment (Class II — Special Controls, product code NSF), submitted by Wako Chemicals USA, Inc. (Mountain View, US). The FDA issued a Cleared decision on February 23, 2011, 370 days after receiving the submission on February 18, 2010. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6030.

Submission Details

510(k) Number	K100464 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 18, 2010
Decision Date	February 23, 2011
Days to Decision	370 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

Product Code	NSF — Test, Alpha Fetoprotein L3 Subfraction (afp-l3%), For Hepatocellular Carcinoma Risk Assessment
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.6030
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.