Cleared Traditional

THROMBOSTRATE CONTROL PLASMAS (K000679) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K000679 · Pacific Hemostasis · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
24d
Days
Class 2
Risk

K000679 is an FDA 510(k) clearance for the THROMBOSTRATE CONTROL PLASMAS. 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 March 24, 2000 after a review of 24 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

Submission Details

510(k) Number K000679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 2000
Decision Date March 24, 2000
Days to Decision 24 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 113d · This submission: 24d
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 98
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K000679.
HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL
K113211 · Instrumentation Laboratory CO · Jan 2012
PT-MULTI-CALIBRATOR, MODEL OPAT07
K093848 · Dade Behring, Inc. · Dec 2010
CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL
K103314 · Medtronic, Inc. · Dec 2010
HEPARIN ASSAY CONTROLS
K103313 · Medtronic, Inc. · Dec 2010
HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE)
K090563 · Instrumentation Laboratory CO · Oct 2009
HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED
K082859 · Instrumentation Laboratory CO · Dec 2008