Cleared Traditional

K090563 - HEMOSIL INR VALIDATE

K090563 is the FDA 510(k) clearance for HEMOSIL INR VALIDATE by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code GGN) cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K090563 · Instrumentation Laboratory CO · Hematology device
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Oct 2009
Decision
221d
Days
Class 2
Risk

K090563 is an FDA 510(k) clearance for the HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE). Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Orangeburg, US). The FDA issued a Cleared decision on October 9, 2009 after a review of 221 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 Instrumentation Laboratory CO devices

Submission Details

510(k) Number K090563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2009
Decision Date October 09, 2009
Days to Decision 221 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
108d slower than avg
Panel avg: 113d · This submission: 221d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGN Plasma, Coagulation Control
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 - GGN Plasma, Coagulation Control

All 46
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K090563.
PT-MULTI-CALIBRATOR, MODEL OPAT07
K093848 · Dade Behring, Inc. · Dec 2010
CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL
K103314 · Medtronic, Inc. · Dec 2010
HEPARIN ASSAY CONTROLS
K103313 · Medtronic, Inc. · Dec 2010
HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED
K082859 · Instrumentation Laboratory CO · Dec 2008
COAGUCHEK XS PT CONTROLS
K063823 · Roche Diagnostics Corp. · Jan 2007
CONTROL PLASMA N, PROC CONTROL PLASMA
K042333 · Dade Behring, Inc. · Dec 2004