Cleared Traditional

K012722 - LYPHOCHEK COAGULATION CONTROL LEVEL 1

K012722 is the FDA 510(k) clearance for LYPHOCHEK COAGULATION CONTROL LEVEL 1 by Bio-Rad. It is a Class 2 Hematology device (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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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

Submission Details

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.

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 55
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
CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3
K992829 · Medical Analysis Systems, Inc. · Nov 1999
LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789
K990858 · Bio-Rad · Apr 1999
SIGMA DIAGNOSTICS ACCUCLOT CONTROL I
K981248 · Sigma Diagnostics, Inc. · Apr 1998