Cleared Traditional

K052825 - VISULIZE FACTOR VIII ANTIGEN KIT

K052825 is the FDA 510(k) clearance for VISULIZE FACTOR VIII ANTIGEN KIT by Affinity Biologicals, Inc.. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K052825 · Affinity Biologicals, Inc. · Hematology device
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Jan 2006
Decision
107d
Days
Class 2
Risk

K052825 is an FDA 510(k) clearance for the VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Affinity Biologicals, Inc. (Ancaster, Ontario, CA). The FDA issued a Cleared decision on January 20, 2006 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - the FDA hematology 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Affinity Biologicals, Inc. devices

Submission Details

510(k) Number K052825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2005
Decision Date January 20, 2006
Days to Decision 107 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 113d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGP Test, Qualitative And Quantitative Factor Deficiency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 Hematology devices follow this clearance model.

Regulatory Peers - GGP Test, Qualitative And Quantitative Factor Deficiency

All 127
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