Product Code: JOZ FDA class 2 21 CFR 864.5700

System, Automated Platelet Aggregation

Hematology

The System, Automated Platelet Aggregation is a hematology diagnostic device used to automatically measure the aggregation response of platelets in platelet-rich plasma when exposed to various aggregating agents, providing information on platelet function for the diagnosis and monitoring of platelet disorders and management of antiplatelet therapies. This device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification prior to marketing. It carries product code JOZ and is regulated under 21 CFR 864.5700, within the Hematology medical specialty. This device is eligible for third-party 510(k) review.

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FEI Numbers

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Basic Information

Product Code: JOZ
Device Class: FDA class 2
Regulation Number: 864.5700
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 38 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K191364	T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01	Feb 14, 2020	Substantially Equivalent	Fujimori Kogyo, Co., Ltd.
K181777	AggreGuide A-100 ADP	Mar 29, 2019	Substantially Equivalent	Aggredyne, Inc.
K163274	AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument	Apr 05, 2017	Substantially Equivalent	Aggredyne, Inc.
K161329	Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel	Dec 02, 2016	Substantially Equivalent	Chrono-Log Corp.
K141427	ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST	Jul 24, 2015	Substantially Equivalent	Accumetrics, Inc.
K140893	CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY	Jan 03, 2015	Substantially Equivalent	Coramed Technologies, LLC
K122162	AGGREGUIDE	Dec 20, 2013	Substantially Equivalent	Aggredyne, Inc.
K103555	MULTIPLATE 5.0 AGGREGOMETER	Jul 27, 2012	Substantially Equivalent	Verum Diagnostica GmbH
K060489	DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS	Jul 21, 2006	Substantially Equivalent	Dade Behring, Inc.
K050265	CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700	Oct 14, 2005	Substantially Equivalent	Chrono-Log Corp.
K051231	VERIFYNOW-P2Y12 ASSAY	Aug 05, 2005	Substantially Equivalent	Accumetrics, Inc.
K042423	VERIFYNOW-ASPIRIN ASSAY	Oct 06, 2004	Substantially Equivalent	Accumetrics, Inc.
K041502	THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY	Sep 01, 2004	Substantially Equivalent	Haemoscope Corp.
K032951	CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A	Apr 02, 2004	Substantially Equivalent	Chrono-Log Corp.
K023761	PLATELETWORKS, MODELS PW-A, PW-C	Feb 14, 2003	Substantially Equivalent	Helena Laboratories
K012701	ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)	Jun 12, 2002	Substantially Equivalent	Accumetrics, Inc.
K013596	MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP)	May 16, 2002	Substantially Equivalent	Accumetrics, Inc.
K011337	ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)	Oct 16, 2001	Substantially Equivalent	Accumetrics, Inc.
K012723	PLATELETWORKS	Sep 28, 2001	Substantially Equivalent	Helena Laboratories
K002885	DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP	Jun 21, 2001	Substantially Equivalent	Dade Behring, Inc.
K992531	ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM	Dec 20, 1999	Substantially Equivalent	Accumetrics, Inc.
K990398	PLATELETWORKS	Dec 01, 1999	Substantially Equivalent	Array Medical, Inc.
K970505	DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/	Nov 17, 1997	Substantially Equivalent	Dade Intl., Inc.
K962426	CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592	Oct 22, 1996	Substantially Equivalent	Chrono-Log Corp.
K954997	CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT	Jan 24, 1996	Substantially Equivalent	Centocor, Inc.
K940792	AGGRO/LINK VW COFACTOR SOFTWARE	Oct 13, 1994	Substantially Equivalent	Chrono-Log Corp.
K862302	BLOOD PLATELET ASSAY METHOD & APPARATUS	Jul 31, 1986	Substantially Equivalent	Bellhouse Medical, Inc.
K851669	MONITOR IV PLUS	Jul 23, 1985	Substantially Equivalent	Helena Laboratories
K800432	HELENA RISTOCETIN	Mar 25, 1980	Substantially Equivalent	Helena Laboratories
K800146	PLATELET AGGREGATION REAGENTS	Feb 05, 1980	Substantially Equivalent	Pacific Hemostasis
K791577	ELVI 840 AGGREGOMETER	Sep 17, 1979	Substantially Equivalent	Volu Sol Medical Industries
K790769	BETA/PAK	May 03, 1979	Substantially Equivalent	Bio/Data Corp.
K781693	COLLAGENREAGENT HORM	Dec 07, 1978	Substantially Equivalent	Hormon-Chemie Munchem Gmch
K781807	REAGENT, FIREFLY #395	Nov 22, 1978	Substantially Equivalent	Chrono-Log Corp.
K780285	SOLUBLE COLLAGEN	Mar 30, 1978	Substantially Equivalent	General Diagnostics
K780047	PLATELET AGGREGATING REAGENTS	Mar 02, 1978	Substantially Equivalent	Dade, Baxter Travenol Diagnostics, Inc.
K770395	THROMBO-CETIN (RISTOCETIN)	Mar 21, 1977	Substantially Equivalent	Bay Area Hema. Onco. Clinic. & Res. L
K760893	AGGRECETIN	Jan 12, 1977	Substantially Equivalent	Bio/Data Corp.