Cleared Special

K020798 - HEMOCHRON JR. SIGNATURE +

K020798 is the FDA 510(k) clearance for HEMOCHRON JR. SIGNATURE + by International Technidyne Corp.. It is a Class 2 Hematology device (product code JPA) cleared through the Special 510(k) pathway after a 16-day FDA review.

K020798 · International Technidyne Corp. · Hematology device
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Mar 2002
Decision
16d
Days
Class 2
Risk

K020798 is an FDA 510(k) clearance for the HEMOCHRON JR. SIGNATURE +. 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 March 28, 2002 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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. Low regulatory complexity profile. 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 K020798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2002
Decision Date March 28, 2002
Days to Decision 16 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
97d faster than avg
Panel avg: 113d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

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 K020798.
HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2
K040359 · Instrumentation Laboratory CO · Mar 2004
MODIFICATION TO STANDARD HUMAN PLASMA
K023141 · Dade Behring, Inc. · Jan 2003
AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED
K021162 · Sigma Diagnostics, Inc. · Aug 2002
BCS SYSTEM
K013114 · Dade Behring, Inc. · Nov 2001
BCT SYSTEM
K011665 · Dade Behring, Inc. · Aug 2001
SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500
K011235 · Dade Behring, Inc. · Jul 2001