Cleared Traditional

K032139 - REAADS VON WILLEBRAND FACTOR ACTIVITY T...

K032139 is the FDA 510(k) clearance for REAADS VON WILLEBRAND FACTOR ACTIVITY T... by Corgenix, Inc.. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K032139 · Corgenix, Inc. · Hematology device
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Apr 2004
Decision
269d
Days
Class 2
Risk

K032139 is an FDA 510(k) clearance for the REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Corgenix, Inc. (Westminster, US). The FDA issued a Cleared decision on April 5, 2004 after a review of 269 days - an extended review cycle.

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 Corgenix, Inc. devices

Submission Details

510(k) Number K032139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2003
Decision Date April 05, 2004
Days to Decision 269 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
156d slower than avg
Panel avg: 113d · This submission: 269d
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
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K032139.
HEMOSIL PROS
K053499 · Instrumentation Laboratory CO · Jan 2006
COATEST SP FVIII
K042576 · Instrumentation Laboratory CO · Dec 2004
HEMOSIL VON WILLEBRAND ACTIVITY
K040843 · Instrumentation Laboratory CO · Apr 2004
MODIFICATION TO COATEST FACTOR VIII
K033631 · Instrumentation Laboratory CO · Dec 2003
PROTEIN S AC
K022290 · Dade Behring, Inc. · Aug 2002
IL TEST PROS
K011424 · Instrumentation Laboratory CO · Jun 2001