Product Code: JBP FDA class 2 21 CFR 864.7140

Activated Whole Blood Clotting Time

Hematology

An activated whole blood clotting time test is a bedside or point-of-care coagulation assay that measures the time for whole blood to clot after activation with a contact activator, used to monitor anticoagulation therapy during cardiac surgery and interventional procedures. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is JBP, regulated under 21 CFR 864.7140, within the Hematology medical specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

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Basic Information

Product Code: JBP
Device Class: FDA class 2
Regulation Number: 864.7140
Medical Specialty: Hematology
Review Panel: HE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 24 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K223635	Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer	Jan 04, 2023	Substantially Equivalent	Sienco, Inc.
K062604	RAPIDTEG TEG-ACT TEST	Jan 31, 2007	Substantially Equivalent	Haemoscope Corp.
K032952	AIACT KIT	Dec 12, 2003	Substantially Equivalent	Sienco, Inc.
K023582	I-STAT KAOLIN ACT TEST	Sep 08, 2003	Substantially Equivalent	I-Stat Corporation
K020914	ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770	May 23, 2002	Substantially Equivalent	Helena Laboratories
K013078	ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752	Jan 10, 2002	Substantially Equivalent	Helena Laboratories
K002528	SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION	Aug 31, 2000	Substantially Equivalent	Sienco, Inc.
K994194	(TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT	Mar 28, 2000	Substantially Equivalent	Cardiovascular Diagnostics, Inc.
K992571	I-STAT SYSTEM	Feb 10, 2000	Substantially Equivalent	I-Stat Corp.
K992851	ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM	Jan 14, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K984141	GBACT + KIT	May 28, 1999	Substantially Equivalent	Sienco, Inc.
K983649	MAX-ACT	Dec 11, 1998	Substantially Equivalent	Array Medical, Inc.
K971935	B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN)	Oct 01, 1997	Substantially Equivalent	B & D Corp.
K964609	ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE	Mar 06, 1997	Substantially Equivalent	Array Medical, Inc.
K960749	HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT	Aug 12, 1996	Substantially Equivalent	International Technidyne Corp.
K941007	CATALOG NO. J-ACT+ & QC-ACT+	Jun 30, 1994	Substantially Equivalent	International Technidyne Corp.
K923594	CLOTTRAC COAGULATION CONTROL	Sep 21, 1992	Substantially Equivalent	Medtronic Hemotec, Inc.
K913861	HEMOCHRON(R) KACT	Oct 18, 1991	Substantially Equivalent	International Technidyne Corp.
K902081	CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL	Jul 03, 1990	Substantially Equivalent	Hemotec, Inc.
K854686	TE-25 COAGURO METER	Jun 04, 1986	Substantially Equivalent	Future Impex Corp.
K860122	HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME	Apr 04, 1986	Substantially Equivalent	Medical Device Consultants, Inc.
K843459	HEMOTEC ACT I SYSTEM	Dec 12, 1984	Substantially Equivalent	Hemotec, Inc.
K832189	HEMOCHRON THROMBOCHRONOMETER	Oct 14, 1983	Substantially Equivalent	International Technidyne Corp.
K790346	ACTIVATOR	Mar 21, 1979	Substantially Equivalent	Tri-Med, Inc.