Cleared Traditional

K023561 - ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM

K023561 is an FDA 510(k) clearance for ITC HGB PRO PROFESSIONAL HEMOGLOBIN TES..., manufactured by International Technidyne Corp.. The device is a Class 2 Hematology device with product code GKR cleared through the Traditional 510(k) pathway after a 100-day FDA review.

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

FDA 510(k) Submission Details - K023561

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
Combination Product No
PCCP Authorized No
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.

GKR Device Classification - Class 2, Special Controls

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 23
Devices cleared under the same product code (GKR) and FDA review panel - the closest regulatory comparables to K023561.
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