Cleared Traditional

K010750 - PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560

K010750 is an FDA 510(k) clearance for PACIFIC HEMOSTASIS INR CONTROL PLASMAS, manufactured by Fisher Diagnostics. The device is a Class 2 Hematology device with product code GGN cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K010750 · Fisher Diagnostics · Hematology device
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Sep 2001
Decision
178d
Days
Class 2
Risk

K010750 is an FDA 510(k) clearance for the PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Fisher Diagnostics (Middletown, US). The FDA issued a Cleared decision on September 7, 2001 after a review of 178 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fisher Diagnostics devices

FDA 510(k) Submission Details - K010750

510(k) Number K010750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2001
Decision Date September 07, 2001
Days to Decision 178 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
65d slower than avg
Panel avg: 113d · This submission: 178d
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 K010750.
HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED)
K021022 · Instrumentation Laboratory CO · May 2002
HEMOSIL NORMAL CONTROL (ASSAYED)
K021023 · Instrumentation Laboratory CO · May 2002
LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783
K012722 · Bio-Rad · Sep 2001
STA-QUALITY HBPM/LMWH KIT
K010324 · Diagnostica Stago, Inc. · Apr 2001
STA -CALIBRATOR HBPM/LMWH KIT
K010350 · Diagnostica Stago, Inc. · Apr 2001
THROMBOSTRATE CONTROL PLASMAS
K000679 · Pacific Hemostasis · Mar 2000