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510(k) Data Aggregation

    K Number
    K230878
    Device Name
    QScout Lab; QScout RLD
    Manufacturer
    Ad Astra Diagnostics, Inc.
    Date Cleared
    2023-11-14

    (229 days)

    Product Code
    GKZ
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ad Astra Diagnostics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OScout™ Lab is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations 18 years and older found in clinical laboratories and point-of-care (POC) settings. The QScout Lab is used with the QScout RLD test to enumerate and classify the following parameters in venous K2/K3EDT A whole blood: - White blood cell count (WBC) - · Neutrophils (NEUT#) - · Lymphocytes (LYMPH#) - · Monocytes (MONO#) - · Eosinophils (EOS#) - · Basophils (BASO#) - · Immature Granulocytes (IG#) - · Percent Neutrophils (NEUT%) - Percent Lymphocytes (LYMPH%) - · Percent Monocytes (MONO%) - · Percent Eosinophils (EOS%) - · Percent Basophils (BASO%) - · Percent Immature Granulocytes (IG%) - · Neutrophil to Lymphocyte Ratio (NLR)
    Device Description
    The QScout™ system is intended for in vitro diagnostic use in screening patient populations 18 years and older found in clinical laboratories and point-of-care (POC) settings. It includes the QScout Lab analyzer, the QScout RLD (Rapid Leukocyte Differential) test, software, and handheld barcode scanner. The QScout system reports white blood cell count and neutrophil to lymphocyte ratio and enumerates and classifies six white blood cell types including immature granulocytes. The QScout RLD test includes a microfluidic chamber of predetermined volume containing a dried reagent of organic compounds to stain and fluoresce white blood cells. Once venous whole blood is transferred to the QScout RLD test, white blood cells mix with the reagent. The QScout RLD test is inserted into the QScout Lab, a quantitative multi-parameter automated hematology analyzer, where an optical imaging system takes images of the test chamber. A machine vision algorithm identifies cells from the images in real time. When analysis is complete, the results are displayed on the screen and can be printed.
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