Cleared Traditional

K052697 - HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL

K052697 is an FDA 510(k) clearance for HEPARIN/PLATELET FACTOR 4 ANTIBODY SERU..., manufactured by Akers Biosciences, Inc.. The device is a Class 2 Hematology device with product code GGN cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K052697 · Akers Biosciences, Inc. · Hematology device
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Jan 2006
Decision
98d
Days
Class 2
Risk

K052697 is an FDA 510(k) clearance for the HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Akers Biosciences, Inc. (Thorofare, US). The FDA issued a Cleared decision on January 4, 2006 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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 Akers Biosciences, Inc. devices

FDA 510(k) Submission Details - K052697

510(k) Number K052697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2005
Decision Date January 04, 2006
Days to Decision 98 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 113d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGN Device Classification - Class 2, Special Controls

Product Code GGN Plasma, Coagulation Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - GGN Plasma, Coagulation Control

All 92
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