Cleared Special

K010599 - PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE

K010599 is an FDA 510(k) clearance for PROTIME MICROCOAGULATION SYSTEM / PROTI..., manufactured by International Technidyne Corp.. The device is a Class 2 Hematology device with product code GJS cleared through the Special 510(k) pathway after a 124-day FDA review.

K010599 · International Technidyne Corp. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
124d
Days
Class 2
Risk

K010599 is an FDA 510(k) clearance for the PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on July 2, 2001 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7750 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K010599

510(k) Number K010599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2001
Decision Date July 02, 2001
Days to Decision 124 days
Submission Type Special
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
11d slower than avg
Panel avg: 113d · This submission: 124d
Pathway characteristics
Modification to existing cleared device.

GJS Device Classification - Class 2, Special Controls

Product Code GJS Test, Time, Prothrombin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7750
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 - GJS Test, Time, Prothrombin

All 122
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K010599.
INRATIO
K020679 · Hemosense, Inc. · May 2002
DADE THROMBOPLASTIN C PLUS
K013155 · Dade Behring, Inc. · Jan 2002
HEMOSIL RECOMBI PLASTIN
K012768 · Instrumentation Laboratory CO · Sep 2001
RUBICON PROTHROMBIN TIME MONITORING SYSTEM
K001699 · Lifescan, Inc. · May 2001
THROMBOREL S
K003870 · Dade Behring, Inc. · Feb 2001
PACIFIC HEMOSTASIS THROMBOPLASTIN D
K994100 · Pacific Hemostasis · Feb 2000
K010599 · PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE
Download PDF FDA Summary International Technid…