Cleared Traditional

K012722 - LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783

K012722 is an FDA 510(k) clearance for LYPHOCHEK COAGULATION CONTROL LEVEL 1, manufactured by Bio-Rad. The device is a Class 2 Hematology device with product code GGN cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K012722 · Bio-Rad · Hematology device
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Optimized for regulatory review, auditing and printing
Sep 2001
Decision
34d
Days
Class 2
Risk

K012722 is an FDA 510(k) clearance for the LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCH.... 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 18, 2001 after a review of 34 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bio-Rad devices

FDA 510(k) Submission Details - K012722

510(k) Number K012722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2001
Decision Date September 18, 2001
Days to Decision 34 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
79d faster than avg
Panel avg: 113d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 91
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K012722.
HEMOSIL HIGH ABNORMAL CONTROL ASSAYED
K021024 · Instrumentation Laboratory CO · May 2002
HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED)
K021022 · Instrumentation Laboratory CO · May 2002
HEMOSIL NORMAL CONTROL (ASSAYED)
K021023 · Instrumentation Laboratory CO · May 2002
PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560
K010750 · Fisher Diagnostics · Sep 2001
STA-QUALITY HBPM/LMWH KIT
K010324 · Diagnostica Stago, Inc. · Apr 2001
STA -CALIBRATOR HBPM/LMWH KIT
K010350 · Diagnostica Stago, Inc. · Apr 2001