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510(k) Data Aggregation
K Number
K103555Device Name
MULTIPLATE 5.0 AGGREGOMETER
Manufacturer
VERUM DIAGNOSTICA GMBH
Date Cleared
2012-07-27
(602 days)
Product Code
JOZ
Regulation Number
864.5700Why did this record match?
Applicant Name (Manufacturer) :
VERUM DIAGNOSTICA GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Multiplate 5.0 aggregometer is intended for in vitro use to measure platelet aggregation in response to Arachidonic acid or ADP in citrated whole blood samples for the qualitative assessment of platelet function.
The ADPtest reagent is a lyophilized preparation of adenosine-5-diphosphate for in vitro diagnostic use to measure platelet aggregation for the qualitative assessment of platelet function. For professional laboratory use only.
The ASPItest reagent is a lyophilized preparation of arachidonic acid (AA) for in vitro diagnostic use to measure platelet aggregation for the qualitative assessment of platelet function. For professional laboratory use only.
For use as an assayed quality control verification of the resistance measure of impedance aggregometry.
Device Description
The Multiplate® 5.0 measures platelet function in whole blood samples using electrical impedance. The Multiplate technology employs multiple electrodes in a disposable test cell. Four electrodes form two independent sensor units allowing for two measurements on the same sample. Five independent channels of the instrument allow for testing of multiple reagents or samples simultaneously.
The instrument provides a five channel aggregometer and an integrated computer system with associated software and is connected to a computer screen, keyboard, mouse, and an electronic pipette. The software is used for data collection and is not used for diagnosis or treatment.
Currently, two test reagents (ADP and Arachidonic acid) are available that activate platelets through specific platelet membrane receptor/signal transduction pathways in order to measure platelet function or alterations in function.
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