Cleared Traditional

K040275 - LYPHOCHEK HEMOSTASIS CONTROL

K040275 is the FDA 510(k) clearance for LYPHOCHEK HEMOSTASIS CONTROL by Bio-Rad. It is a Class 2 Hematology device (product code GGN) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K040275 · Bio-Rad · Hematology device
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Feb 2004
Decision
22d
Days
Class 2
Risk

K040275 is an FDA 510(k) clearance for the LYPHOCHEK HEMOSTASIS CONTROL. 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 February 27, 2004 after a review of 22 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 K040275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2004
Decision Date February 27, 2004
Days to Decision 22 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
91d faster than avg
Panel avg: 113d · This submission: 22d
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 K040275.
CONTROL PLASMA N AND CONTROL PLASMA P
K042209 · Dade Behring, Inc. · Oct 2004
HEPARINASE HR ACT CONTROL, MODEL 550-12
K042175 · Medtronic Vascular · Oct 2004
PURPLE/BLACK HEPARIN ASSAY CONTROL
K042206 · Medtronic Vascular · Oct 2004
LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743
K032611 · Bio-Rad · Sep 2003
LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3
K032017 · Bio-Rad · Aug 2003
CONTROL PLASMA LMW HEPARIN
K030965 · Instrumentation Laboratory CO · Jun 2003