Cleared Special

K010599 - PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE (FDA 510(k) Clearance)

Class II Hematology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K010599 · International Technidyne Corp. · Hematology device
Download Printable Device Report (PDF)
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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.

View all International Technidyne Corp. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 113d · This submission: 124d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 126
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