Cleared Traditional

K071781 - PF4 IGG

K071781 is an FDA 510(k) clearance for PF4 IGG, manufactured by Genetic Testing Institute. The device is a Class 2 Hematology device with product code LCO cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K071781 · Genetic Testing Institute · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
170d
Days
Class 2
Risk

K071781 is an FDA 510(k) clearance for the PF4 IGG. 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 December 19, 2007 after a review of 170 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K071781

510(k) Number K071781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2007
Decision Date December 19, 2007
Days to Decision 170 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
57d slower than avg
Panel avg: 113d · This submission: 170d
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 K071781.
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
ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A
K071255 · Hyphen Biomed · Sep 2007
PF4 ENHANCED SOLID PHASE ELISA
K053559 · Genetic Testing Institute · Jan 2006
HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY
K040293 · Akers Laboratories, Inc. · May 2004
K071781 · PF4 IGG
Download PDF FDA Summary Genetic Testing Insti…