Cleared Traditional

K100464 - UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION (FDA 510(k) Clearance)

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K100464 · Wako Chemicals USA, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
370d
Days
Class 2
Risk

K100464 is an FDA 510(k) clearance for the UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL.... Classified as Test, Alpha Fetoprotein L3 Subfraction (afp-l3%), For Hepatocellular Carcinoma Risk Assessment (product code NSF), Class II - Special Controls.

Submitted by Wako Chemicals USA, Inc. (Mountain View, US). The FDA issued a Cleared decision on February 23, 2011 after a review of 370 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6030 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Wako Chemicals USA, Inc. devices

Submission Details

510(k) Number K100464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
266d slower than avg
Panel avg: 104d · This submission: 370d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NSF Test, Alpha Fetoprotein L3 Subfraction (afp-l3%), For Hepatocellular Carcinoma Risk Assessment
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.