Cleared Special

K032611 - LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743

K032611 is an FDA 510(k) clearance for LYPHOCHEK COAGULATION CONTROL, manufactured by Bio-Rad. The device is a Class 2 Hematology device with product code GGN cleared through the Special 510(k) pathway after a 23-day FDA review.

K032611 · Bio-Rad · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
23d
Days
Class 2
Risk

K032611 is an FDA 510(k) clearance for the LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Bio-Rad (Irvine, US). The FDA issued a Cleared decision on September 17, 2003 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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.

FDA 510(k) Submission Details - K032611

510(k) Number K032611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2003
Decision Date September 17, 2003
Days to Decision 23 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
90d faster than avg
Panel avg: 113d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

GGN Device Classification - Class 2, Special Controls

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 98
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K032611.
HEPARINASE HR ACT CONTROL, MODEL 550-12
K042175 · Medtronic Vascular · Oct 2004
PURPLE/BLACK HEPARIN ASSAY CONTROL
K042206 · Medtronic Vascular · Oct 2004
LYPHOCHEK HEMOSTASIS CONTROL
K040275 · Bio-Rad · Feb 2004
LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3
K032017 · Bio-Rad · Aug 2003
CONTROL PLASMA LMW HEPARIN
K030965 · Instrumentation Laboratory CO · Jun 2003
LIQUICHEK D-DIMER CONTROL, MODEL 356, 357
K030182 · Bio-Rad · Feb 2003
K032611 · LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743
Download PDF FDA Summary Bio-Rad