Cleared Traditional

K941007 - CATALOG NO. J-ACT+ & QC-ACT+

K941007 is the FDA 510(k) clearance for CATALOG NO. J-ACT+ & QC-ACT+ by International Technidyne Corp.. It is a Class 2 Hematology device (product code JBP) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K941007 · International Technidyne Corp. · Hematology device
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Jun 1994
Decision
121d
Days
Class 2
Risk

K941007 is an FDA 510(k) clearance for the CATALOG NO. J-ACT+ & QC-ACT+. Classified as Activated Whole Blood Clotting Time (product code JBP), Class II - Special Controls.

Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on June 30, 1994 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7140 - 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 K941007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1994
Decision Date June 30, 1994
Days to Decision 121 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
8d slower than avg
Panel avg: 113d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JBP Activated Whole Blood Clotting Time
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7140
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 - JBP Activated Whole Blood Clotting Time

Devices cleared under the same product code (JBP) and FDA review panel - the closest regulatory comparables to K941007.
ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770
K020914 · Helena Laboratories · May 2002
ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752
K013078 · Helena Laboratories · Jan 2002
ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM
K992851 · Roche Diagnostics Corp. · Jan 2000