Not Cleared Post-NSE

DEN050002 - LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS

DEN050002 is an FDA 510(k) submission for LBA AFP-L3, manufactured by Wako Chemicals USA, Inc.. The device is a Class 2 Immunology device with product code NSF cleared through the Post-NSE 510(k) pathway after a 42-day FDA review.

DEN050002 · Wako Chemicals USA, Inc. · Immunology device
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May 2005
Decision
42d
Days
Class 2
Risk

DEN050002 is an FDA 510(k) submission (not cleared) for the LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS. 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. (Richmond, US). The FDA issued a Not Cleared (DENG) decision on May 19, 2005 after a review of 42 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Immunology review framework.

FDA 510(k) Submission Details - DEN050002

510(k) Number DEN050002 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 07, 2005
Decision Date May 19, 2005
Days to Decision 42 days
Submission Type Post-NSE
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 105d · This submission: 42d
Pathway characteristics

NSF Device Classification - Class 2, Special Controls

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.

DEN050002 · LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS
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