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510(k) Data Aggregation

    K Number
    K181777
    Device Name
    AggreGuide A-100 ADP
    Manufacturer
    Aggredyne, Inc.
    Date Cleared
    2019-03-29

    (269 days)

    Product Code
    JOZ
    Regulation Number
    864.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aggredyne, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AggreGuide A-100 ADP Assay is used with the AggreGuide A-100 instrument in non-CLIA waived physician's office or clinical laboratory for the detection of platelet dysfunction in patients age 22 or older receiving P2Y 12 antiplatelet drugs, prasugrel and ticagrelor, using 3.2% sodium citrated whole blood. The AggreGuide A-100 ADP Assay is a semi-quantitative assay. The level of platelet aggregation is determined by the platelet activity index (PAI) where values < 4.7 PAI suggest that platelet dysfunction is due to the presence of P2Y 12 antiplatelet drugs, prasugrel and ticagrelor. The test results should be interpreted in conjunction with all laboratory data available to the clinician.
    Device Description
    The AggreGuide A-100 ADP Assay is an individual use, disposable assay cartridge for use with the AggreGuide A-100 instrument. The cartridge contains preloaded freeze dried agonist. The level of platelet aggregation induced by the adenosine diphosphate (ADP) agonist in a sample of whole blood is detected within the cartridge. The amount of platelet aggregation is measured by detecting and quantifying the laser light scattering caused by platelet aggregates. P2Y12 inhibitor drugs e.g. clopidogrel, and ticagrelor are known to inhibit the level of platelet aggregation, causing platelet dysfunction.
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    K Number
    K163274
    Device Name
    AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument
    Manufacturer
    Aggredyne, Inc.
    Date Cleared
    2017-04-05

    (135 days)

    Product Code
    JOZ
    Regulation Number
    864.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aggredyne, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AggreGuide A-100 AA Assay is a qualitative system to aid in the detection of platelet dysfunction due to aspirin ingestion by those 18 years of age or older in 3.2% citrated venous whole blood using the AggreGuide A-100 instrument. For professional use. This test is not for use in patients with underlying congenital platelet abnormalities, patients with non-aspirin induced acquired platelet abnormalities or in patients receiving non-aspirin anti-platelet agents. The test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician.
    Device Description
    The AggreGuide A-100 is a laser light scattering system that detects the level of platelet aggregation induced by arachidonic acid agonist in whole blood in motion. The system consists of an instrument and a disposable assay cartridge with pre-loaded freeze dried agonist. A whole blood sample is added to a disposable cartridge that is preloaded with freeze dried arachidonic acid agonist (AA) in a reaction chamber for an individual test. The amount of platelet aggregation is measured by detecting the laser light scattering caused by platelet aggregates. Aspirin is known to inhibit the level of platelet aggregation, or activity, when blood is mixed with arachidonic acid.
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    K Number
    K122162
    Device Name
    AGGREGUIDE
    Manufacturer
    AGGREDYNE, INC.
    Date Cleared
    2013-12-20

    (518 days)

    Product Code
    JOZ
    Regulation Number
    864.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    AGGREDYNE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AggreGuide A-100 AA Assay is a qualitative system to aid in the detection of platelet dysfunction due to aspirin ingestion by those 18 years of age or older in 3.2% citrated venous whole blood using the AggreGuide A-100 instrument. For professional use. This test is not for use in patients with underlying congenital platelet abnormalities, patients with non-aspirin induced acquired platelet abnormalities or in patients receiving non-aspirin antiplatelet agents. The test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician.
    Device Description
    The AggreGuide A-100 is a laser light scattering system that detects the level of platelet aggregation induced by arachidonic acid agonist in whole blood in motion. The system consists of an instrument and a disposable assay cartridge with pre-loaded freeze dried agonist. A whole blood sample is added to a disposable cartridge that is preloaded with freeze dried arachidonic acid agonist (AA) in a reaction chamber for an individual test. The amount of platelet aggregation is measured by detecting the laser light scattering caused by platelet aggregates. Aspirin is known to inhibit the level of platelet aggregation, or activity, when blood is mixed with arachidonic acid.
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