Cleared Traditional

K023561 - ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM (FDA 510(k) Clearance)

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

K023561 · International Technidyne Corp. · Hematology device
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Jan 2003
Decision
100d
Days
Class 2
Risk

K023561 is an FDA 510(k) clearance for the ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM. Classified as System, Hemoglobin, Automated (product code GKR), Class II - Special Controls.

Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on January 31, 2003 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5620 - 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 International Technidyne Corp. devices

Submission Details

510(k) Number K023561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2002
Decision Date January 31, 2003
Days to Decision 100 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
13d faster than avg
Panel avg: 113d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKR System, Hemoglobin, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5620
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 - GKR System, Hemoglobin, Automated

All 38
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