Cleared Traditional

K971428 - COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0

K971428 is an FDA 510(k) clearance for COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0, manufactured by Pacific Hemostasis. The device is a Class 2 Hematology device with product code GGN cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K971428 · Pacific Hemostasis · Hematology device
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Jun 1997
Decision
61d
Days
Class 2
Risk

K971428 is an FDA 510(k) clearance for the COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Pacific Hemostasis (Huntersville, US). The FDA issued a Cleared decision on June 17, 1997 after a review of 61 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 Pacific Hemostasis devices

FDA 510(k) Submission Details - K971428

510(k) Number K971428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1997
Decision Date June 17, 1997
Days to Decision 61 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
52d faster than avg
Panel avg: 113d · This submission: 61d
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 K971428.
CRYO CHECK INR VALIDATION SET
K971219 · Precision Biologicals, Inc. · Aug 1997
CRYO CHECK APC RESISTANT PLASMA
K971222 · Precision Biologicals, Inc. · Aug 1997
STA LIATEST CONTROL [N]+[P] KIT
K964716 · American Bioproducts Co. · Jun 1997
TAS PT-NCTEST CONTROLS
K971748 · Cardiovascular Diagnostics, Inc. · May 1997
LYPHOCHEK COAGULATION CONTROL
K964963 · Bio-Rad · Feb 1997
STA - VWF CONTROL [N]+[P] KIT
K962674 · American Bioproducts Co. · Jul 1996