Cleared Traditional

K923761 - ITC MICROSAMPLE COAGULATION ANALYZER SY...

K923761 is the FDA 510(k) clearance for ITC MICROSAMPLE COAGULATION ANALYZER SY... by International Technidyne Corp.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K923761 · International Technidyne Corp. · Hematology device
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Jan 1993
Decision
177d
Days
Class 2
Risk

K923761 is an FDA 510(k) clearance for the ITC MICROSAMPLE COAGULATION ANALYZER SYSTEM. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on January 21, 1993 after a review of 177 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 International Technidyne Corp. devices

Submission Details

510(k) Number K923761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1992
Decision Date January 21, 1993
Days to Decision 177 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 113d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
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 - JPA System, Multipurpose For In Vitro Coagulation Studies

All 85
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K923761.
BOEHRINGER MANNHEIM COAGUCHEK SYSTEM
K930454 · Boehringer Mannheim Corp. · Aug 1993
VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA
K930849 · Organon Teknika Corp. · Apr 1993
OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376
K926222 · Helena Laboratories · Feb 1993
CALCIUM CHLORIDE/DIETHYLBARB ACETATE BUFF SOLUTION
K924509 · Behring Diagnostics, Inc. · Dec 1992
MULTI-CHANNEL DISCRETE ANALYZER (MDA-180)
K924453 · Organon Teknika Corp. · Dec 1992
BEHRING FIBRINTIMER A
K924124 · Behring Diagnostics, Inc. · Dec 1992