Cleared Traditional

ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE (K964609) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K964609 · Array Medical, Inc. · Hematology device
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Mar 1997
Decision
108d
Days
Class 2
Risk

K964609 is an FDA 510(k) clearance for the ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD .... Classified as Activated Whole Blood Clotting Time (product code JBP), Class II - Special Controls.

Submitted by Array Medical, Inc. (Bridgewater, US). The FDA issued a Cleared decision on March 6, 1997 after a review of 108 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 Array Medical, Inc. devices

Submission Details

510(k) Number K964609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1996
Decision Date March 06, 1997
Days to Decision 108 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 113d · This submission: 108d
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

All 23
Devices cleared under the same product code (JBP) and FDA review panel - the closest regulatory comparables to K964609.
Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer
K223635 · Sienco, Inc. · Jan 2023
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