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510(k) Data Aggregation

    K Number
    K241037
    Device Name
    ABL90 FLEX PLUS System
    Manufacturer
    Radiometer Medicals ApS
    Date Cleared
    2025-01-14

    (273 days)

    Product Code
    CEM, CGA, JFP, JGS, KHP
    Regulation Number
    862.1600
    Why did this record match?
    Applicant Name (Manufacturer) :

    Radiometer Medicals ApS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ABL90 FLEX PLUS System is an in vitro diagnostic, portable, automated analyzer that quantitatively measures electrolytes (cK+, cNa+, cCa2+), glucose, and lactate in heparinized arterial and venous whole blood. The ABL90 FLEX PLUS System is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient, or point-of-care setting. These tests are only performed under a physician's order. Potassium (cK+): Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Sodium (cNa+): Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, delydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance. Calcium (cCa2+): Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. Glucose (cGlu): Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. Lactate (cLac): The lactate measure the concentration of lactate. Lactate measurements are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidity of the blood).
    Device Description
    The ABL90 FLEX PLUS System consists of the ABL90 FLEX PLUS analyzer, sensor cassette and solution pack consumables, and related accessories for the analyzers. The ABL90 FLEX PLUS is a portable, automated system intended for in vitro testing of samples of balanced heparinized whole blood for electrolytes (cK+, cNa*, cCa²), glucose, and lactate. The ABL90 FLEX PLUS System has an automated sample inlet mechanism, which can collect blood through two different measuring modes: the S65 syringe mode and the SP65 short probe mode.
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    K Number
    K240998
    Device Name
    ABL90 FLEX PLUS System
    Manufacturer
    Radiometer Medicals ApS
    Date Cleared
    2024-12-13

    (246 days)

    Product Code
    CHL, GHS, GKR
    Regulation Number
    862.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    Radiometer Medicals ApS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ABL90 FLEX PLUS System is an in vitro diagnostic, portable, automated analyzer that quantitatively measures pH, blood gas (p02), Oximetry (s02, ctHb, FCOHb, FCOHb, FMetHb, and FHHb), in heparinized arterial and venous whole blood. The ABL90 FLEX PLUS System is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient, or point-of-care setting. These tests are only performed under a physician's order. pH and pO2: pH and pO2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances. sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin plus reduced hemoglobin. ctHb (Total Hemoglobin): Total hemoglobin measure the hemoglobin content of whole blood for the detection of anemia. FO2Hb: Oxyhemoglobin as a fraction of total hemoglobin. FCOHb: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning. FMetHb: Methemoglobin as a fraction of total hemoglobin. FHHb: Reduced hemoglobin as a fraction of total hemoglobin.
    Device Description
    The ABL90 FLEX PLUS System consists of the ABL90 FLEX PLUS analyzer, sensor cassette and solution pack consumables, and related accessories for the analyzers. The sensor cassettes, solution packs and related accessories are compatible with both analyzers. Multiple versions of the sensor cassettes are available. The sensor cassette versions vary in the maximum number of tests and availability of sensors for use. The solution pack is available in two versions, differing in the number of activities available.
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