Cleared Traditional

K040293 - HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY

K040293 is an FDA 510(k) clearance for HEALTHTEST HEPARIN/PLATELET FACTOR 4 AN..., manufactured by Akers Laboratories, Inc.. The device is a Class 2 Hematology device with product code LCO cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K040293 · Akers Laboratories, Inc. · Hematology device
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May 2004
Decision
112d
Days
Class 2
Risk

K040293 is an FDA 510(k) clearance for the HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY. Classified as Platelet Factor 4 Radioimmunoassay (product code LCO), Class II - Special Controls.

Submitted by Akers Laboratories, Inc. (Thorofare, US). The FDA issued a Cleared decision on May 28, 2004 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7695 - 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 Laboratories, Inc. devices

FDA 510(k) Submission Details - K040293

510(k) Number K040293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2004
Decision Date May 28, 2004
Days to Decision 112 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
1d faster than avg
Panel avg: 113d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCO Device Classification - Class 2, Special Controls

Product Code LCO Platelet Factor 4 Radioimmunoassay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7695
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 - LCO Platelet Factor 4 Radioimmunoassay

All 12
Devices cleared under the same product code (LCO) and FDA review panel - the closest regulatory comparables to K040293.
PF4 IGG
K071781 · Genetic Testing Institute · Dec 2007
ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A
K071255 · Hyphen Biomed · Sep 2007
PF4 ENHANCED SOLID PHASE ELISA
K053559 · Genetic Testing Institute · Jan 2006
ASSERACHROM HPIA TEST KIT
K003767 · Diagnostica Stago, Inc. · Feb 2001
GTI-PF4 ELISA
K983379 · Genetic Testing Institute · Mar 1999
ENZYGNOST PLATELET FACTOR 4 (PF4) KIT
K890633 · Behring Diagnostics, Inc. · Apr 1989