Cleared Traditional

K082205 - FACTOR VIII ANTIBODY SCREEN

K082205 is an FDA 510(k) clearance for FACTOR VIII ANTIBODY SCREEN, manufactured by Genetic Testing Institute. The device is a Class 2 Hematology device with product code GGP cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K082205 · Genetic Testing Institute · Hematology device
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Nov 2008
Decision
107d
Days
Class 2
Risk

K082205 is an FDA 510(k) clearance for the FACTOR VIII ANTIBODY SCREEN. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Genetic Testing Institute (Waukesha, US). The FDA issued a Cleared decision on November 20, 2008 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 Genetic Testing Institute devices

FDA 510(k) Submission Details - K082205

510(k) Number K082205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2008
Decision Date November 20, 2008
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.

GGP Device Classification - Class 2, Special Controls

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 156
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