Cleared Traditional

K990449 - HEMOCHRON ELECTRONIC SYSTEM VERIFICATIO...

K990449 is the FDA 510(k) clearance for HEMOCHRON ELECTRONIC SYSTEM VERIFICATIO... by International Technidyne Corp.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K990449 · International Technidyne Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
60d
Days
Class 2
Risk

K990449 is an FDA 510(k) clearance for the HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE. 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 13, 1999 after a review of 60 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all International Technidyne Corp. devices

Submission Details

510(k) Number K990449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1999
Decision Date April 13, 1999
Days to Decision 60 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
53d faster than avg
Panel avg: 113d · This submission: 60d
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 K990449.
ACL 9000 SYSTEM
K000053 · Instrumentation Laboratory CO · Mar 2000
BEHRING COAGULATION SYSTEM (BCS)
K992959 · Dade Behring, Inc. · Jan 2000
DADE BEHRING BFTII
K984501 · Dade Behring, Inc. · Jul 1999
STAR AUTOMATED MULTI-PARAMETRIC ANALYZER
K983460 · American Bioproducts Co. · Nov 1998
SYSMEX AUTOMATED COAGULATION ANALYZER CA-500
K981711 · Dade Behring, Inc. · Sep 1998
COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING
K974569 · Boehringer Mannheim Corp. · Jan 1998