Cleared Special

PF4 IgG assay (K201311) - FDA 510(k) Clearance

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

K201311 · Immucor Gti Diagnostics, Inc. · Hematology device
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Jun 2020
Decision
31d
Days
Class 2
Risk

K201311 is an FDA 510(k) clearance for the PF4 IgG assay. Classified as Platelet Factor 4 Radioimmunoassay (product code LCO), Class II - Special Controls.

Submitted by Immucor Gti Diagnostics, Inc. (Waukesha, US). The FDA issued a Cleared decision on June 18, 2020 after a review of 31 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 Immucor Gti Diagnostics, Inc. devices

Submission Details

510(k) Number K201311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2020
Decision Date June 18, 2020
Days to Decision 31 days
Submission Type Special
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
82d faster than avg
Panel avg: 113d · This submission: 31d
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 K201311.
HemosIL CL HIT-IgG(PF4-H)
K243374 · Instrumentation Laboratory (IL) Co. · Jan 2025
PF4 Enhanced assay
K201570 · Immucor Gti Diagnostics, Inc. · Sep 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