Cleared Traditional

K945078 - HEMOCHRON HNPT/FACTOR VI PT+

K945078 is the FDA 510(k) clearance for HEMOCHRON HNPT/FACTOR VI PT+ by International Technidyne Corp.. It is a Class 2 Hematology device (product code GJS) cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K945078 · International Technidyne Corp. · Hematology device
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Apr 1995
Decision
193d
Days
Class 2
Risk

K945078 is an FDA 510(k) clearance for the HEMOCHRON HNPT/FACTOR VI PT+. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on April 28, 1995 after a review of 193 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7750 - 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 K945078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1994
Decision Date April 28, 1995
Days to Decision 193 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
80d slower than avg
Panel avg: 113d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GJS Test, Time, Prothrombin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7750
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 - GJS Test, Time, Prothrombin

All 76
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K945078.
THROMBOPLASTIN-LI REAGENT
K951820 · Helena Laboratories · Oct 1995
MDA SIMPLASTIN LS
K952608 · Organon Teknika Corp. · Oct 1995
COAGUCHEK SYSTEM
K942884 · Boehringer Mannheim Corp. · May 1995
ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT
K935748 · Ortho Diagnostic Systems, Inc. · Apr 1995
DADE INNOVIN II
K935702 · Baxter Diagnostics, Inc. · Nov 1994
HELENA THROMBOPLASTIN-MI REAGENT
K940310 · Helena Laboratories · Apr 1994