Cleared Traditional

K964609 - ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE

K964609 is an FDA 510(k) clearance for ACTALYKE ACTIVATED CLOTTING TIME TEST S..., manufactured by Array Medical, Inc.. The device is a Class 2 Hematology device with product code JBP cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K964609 · Array Medical, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K964609

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
Combination Product No
PCCP Authorized No
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.

JBP Device Classification - Class 2, Special Controls

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 14
Devices cleared under the same product code (JBP) and FDA review panel - the closest regulatory comparables to K964609.
GBACT + KIT
K984141 · Sienco, Inc. · May 1999
MAX-ACT
K983649 · Array Medical, Inc. · Dec 1998
B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN)
K971935 · B & D Corp. · Oct 1997
HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT
K960749 · International Technidyne Corp. · Aug 1996
CATALOG NO. J-ACT+ & QC-ACT+
K941007 · International Technidyne Corp. · Jun 1994
HEMOCHRON(R) KACT
K913861 · International Technidyne Corp. · Oct 1991