Cleared Traditional

K904454 - HEMOCHRON PROTHROMBIN TIME/MODIFICATION

K904454 is the FDA 510(k) clearance for HEMOCHRON PROTHROMBIN TIME/MODIFICATION by International Technidyne Corp.. It is a Class 2 Hematology device (product code GJS) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K904454 · International Technidyne Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1990
Decision
91d
Days
Class 2
Risk

K904454 is an FDA 510(k) clearance for the HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION. 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 December 17, 1990 after a review of 91 days - within the typical 510(k) review window.

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 K904454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1990
Decision Date December 17, 1990
Days to Decision 91 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 113d · This submission: 91d
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 K904454.
SIMPLASTIN L
K915746 · Organon Teknika Corp. · Feb 1992
HELENA THROMBOPLASTIN REAGENT WITH DILUENT
K905807 · Helena Laboratories · Apr 1991
HELENA THROMBOPLASTIN REAGENT, MODIFICATION
K905857 · Helena Laboratories · Feb 1991
THROMBOPLASTIN WITH CALCIUM
K902096 · Sigma Chemical Co. · Jul 1990
THROMBOPLASTIN.C PLUS
K901325 · Baxter Healthcare Corp · May 1990
HELENA THROMBOPLASTIN REAGENT
K892050 · Helena Laboratories · Jun 1989