Cleared Special

PF4 ENHANCED SOLID PHASE ELISA (K053559) - FDA 510(k) Clearance

Class II Hematology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K053559 · Genetic Testing Institute · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
30d
Days
Class 2
Risk

K053559 is an FDA 510(k) clearance for the PF4 ENHANCED SOLID PHASE ELISA. Classified as Platelet Factor 4 Radioimmunoassay (product code LCO), Class II - Special Controls.

Submitted by Genetic Testing Institute (Waukesha, US). The FDA issued a Cleared decision on January 20, 2006 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7695 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Genetic Testing Institute devices

Submission Details

510(k) Number K053559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2005
Decision Date January 20, 2006
Days to Decision 30 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 113d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 K053559.
HemosIL CL HIT-IgG(PF4-H)
K243374 · Instrumentation Laboratory (IL) Co. · Jan 2025
PF4 Enhanced assay
K201570 · Immucor Gti Diagnostics, Inc. · Sep 2020
PF4 IgG assay
K201311 · Immucor Gti Diagnostics, Inc. · Jun 2020
HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls
K170854 · Instrumentation Laboratory CO · Sep 2017
HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls
K153137 · Instrumentation Laboratory CO · Jul 2016