Cleared Special

K030818 - HEMOCHRON RESPONSE/SYSTEM

K030818 is an FDA 510(k) clearance for HEMOCHRON RESPONSE/SYSTEM, manufactured by International Technidyne Corp.. The device is a Class 2 Hematology device with product code JPA cleared through the Special 510(k) pathway after a 19-day FDA review.

K030818 · International Technidyne Corp. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
19d
Days
Class 2
Risk

K030818 is an FDA 510(k) clearance for the HEMOCHRON RESPONSE/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 April 2, 2003 after a review of 19 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.

FDA 510(k) Submission Details - K030818

510(k) Number K030818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2003
Decision Date April 02, 2003
Days to Decision 19 days
Submission Type Special
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
94d faster than avg
Panel avg: 113d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

JPA Device Classification - Class 2, Special Controls

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 170
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K030818.
HEMOCHRON SIGNATURE ELITE
K050016 · International Technidyne Corp. · Feb 2005
HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2
K040359 · Instrumentation Laboratory CO · Mar 2004
POTENS +
K033137 · Wada, Inc. · Dec 2003
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
HEMOCHRON JR. SIGNATURE +
K020798 · International Technidyne Corp. · Mar 2002
K030818 · HEMOCHRON RESPONSE/SYSTEM
Download PDF FDA Summary International Technid…