Cleared Traditional

K945078 - HEMOCHRON HNPT/FACTOR VI PT+

K945078 is an FDA 510(k) clearance for HEMOCHRON HNPT/FACTOR VI PT+, manufactured by International Technidyne Corp.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K945078

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
Combination Product No
PCCP Authorized No
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.

GJS Device Classification - Class 2, Special Controls

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 107
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
THROMBOSCREEN THROMBOPLASTIN-DS
K940082 · Pacific Hemostasis · Feb 1995
DADE INNOVIN II
K935702 · Baxter Diagnostics, Inc. · Nov 1994