Cleared Traditional

K062306 - PLASMACON N

K062306 is the FDA 510(k) clearance for PLASMACON N by R2 Diagnostics, Inc.. It is a Class 2 Hematology device (product code GGC) cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K062306 · R2 Diagnostics, Inc. · Hematology device
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Mar 2007
Decision
220d
Days
Class 2
Risk

K062306 is an FDA 510(k) clearance for the PLASMACON N, PLASMACON L-1, PLASMACON L-2. Classified as Control, Plasma, Abnormal (product code GGC), Class II - Special Controls.

Submitted by R2 Diagnostics, Inc. (South Bend, US). The FDA issued a Cleared decision on March 16, 2007 after a review of 220 days - an extended review cycle.

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 R2 Diagnostics, Inc. devices

Submission Details

510(k) Number K062306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2006
Decision Date March 16, 2007
Days to Decision 220 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
107d slower than avg
Panel avg: 113d · This submission: 220d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGC Control, Plasma, Abnormal
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 - GGC Control, Plasma, Abnormal

All 30
Devices cleared under the same product code (GGC) and FDA review panel - the closest regulatory comparables to K062306.
HEMOSIL LA POSITIVE CONTROL
K102552 · Instrumentation Laboratory CO · Apr 2011
SPECIALTY ASSAYED CONTROL-2
K100103 · Helena Laboratories · Dec 2010
CONTROL PLASMA P
K023312 · Dade Behring, Inc. · Nov 2002
LYPHOCHEK HEMOSTASIS, MODELS 798, 799
K020878 · Bio-Rad · Apr 2002
SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
K020109 · Sigma Diagnostics, Inc. · Feb 2002
K-ASSAY D-DIMER CONTROLS
K012422 · Kamiya Biomedical Co. · Aug 2001