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510(k) Data Aggregation

    K Number
    K093834
    Device Name
    CRIT-LINE ANEMIA MANAGEMENT SOFTWARE
    Manufacturer
    HEMA METRICS, LLC
    Date Cleared
    2010-09-29

    (289 days)

    Product Code
    MSQ, JQP
    Regulation Number
    866.3110
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEMA METRICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Crit-Line Anemia Management software is a database application used to record, track and trend patient data as pertains to the management of anemia, and provide a dosage recommendation.
    Device Description
    The CLAM software is a database application that records, tracks, trends, and analyzes patient data (Hematocrit, Oxygen Saturation, and Hemoglobin) along with current ESA dose in order to effectively manage anemia. During dialysis treatment, the CLAM downloads initial, real-time Hematocrit (HCT), Oxygen Saturation (SaO2), and Hemoglobin (Hb) data from the Crit Line blood monitor. The CLAM software trends this patient data along with current Erythropoiesis Stimulating Agent (ESA) dosage to determine the patient's Hb levels, the need (if any) for ESA dosing, and to track patient's response to treatment. The CLAM software uses a proprietary algorithm to calculate a recommendation for ESA dosage based on patient data trends and current ESA dose in order to establish and maintain predetermined patient Hb levels. The CLAM proprietary algorithm used to determine ESA dosing for anemia treatment is based on the current manual algorithm. In addition, the CLAM software generates and prints patient reports for review and record keeping. The CLAM software resides on a host computer separate from the Crit Line units and acquires real-time data from the clinic's Crit Line monitors via wireless radio signal or by a serial cable.
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