Cleared Traditional

K915344 - HEMOCHRON ONESTEP APTT TEST

K915344 is an FDA 510(k) clearance for HEMOCHRON ONESTEP APTT TEST, manufactured by International Technidyne Corp.. The device is a Class 2 Hematology device with product code GFO cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K915344 · International Technidyne Corp. · Hematology device
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Feb 1992
Decision
77d
Days
Class 2
Risk

K915344 is an FDA 510(k) clearance for the HEMOCHRON ONESTEP APTT TEST. Classified as Activated Partial Thromboplastin (product code GFO), Class II - Special Controls.

Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on February 11, 1992 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7925 - 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

FDA 510(k) Submission Details - K915344

510(k) Number K915344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1991
Decision Date February 11, 1992
Days to Decision 77 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
36d faster than avg
Panel avg: 113d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GFO Device Classification - Class 2, Special Controls

Product Code GFO Activated Partial Thromboplastin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7925
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 - GFO Activated Partial Thromboplastin

All 43
Devices cleared under the same product code (GFO) and FDA review panel - the closest regulatory comparables to K915344.
ACS FREEZE-DRIED APTT REAGENT
K921223 · Analytical Control Systems, Inc. · Aug 1992
ACS APCT REAGENT
K921118 · Analytical Control Systems, Inc. · Jul 1992
ELLAGIC ACID APTT REAGENT
K915418 · Helena Laboratories · Feb 1992
HEMOCHRON(R) APTT, MODIFICATION
K911994 · International Technidyne Corp. · Jul 1991
ANTICARDIOLIPIN ANTIBODY TEST SYSTEM
K903531 · Medical Innovations Corp. · Jan 1991
THE THERATEST ACA TEST
K905301 · Theratest Laboratories, Inc. · Jan 1991