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510(k) Data Aggregation

    K Number
    K974343
    Device Name
    DADE INNOVIN
    Manufacturer
    DADE INTL., INC.
    Date Cleared
    1998-07-22

    (245 days)

    Product Code
    GJS
    Regulation Number
    864.7750
    Why did this record match?
    Applicant Name (Manufacturer) :

    DADE INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in prothrombin time determinations and prothrombin time-based assays.
    Device Description
    Dade® Innovin® is a lyophilized preparation of purified recombinant human tissue factor produced in E. coli combined with synthetic phospholipids, calcium and stabilizers. The reagent initiates clotting via the extrinsic common pathway in a global screening test, the prothrombin time (PT). The obtained clotting time detects single or combined deficiencies of the extrinsic coagulation system indicative of hereditary and acquired coagulation disorders, is a sensitive monitoring test for oral anticoagulation therapy and an assay for specific coagulation factors.
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    K Number
    K970505
    Device Name
    DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/
    Manufacturer
    DADE INTL., INC.
    Date Cleared
    1997-11-17

    (280 days)

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

    DADE INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To aid in the detection of platelet dysfunction in citrated human whole blood for use in patients with a suspected disorder of primary hemostasis.
    Device Description
    The Dade® PFA-100™ system is an instrument and test reagents in which the process of platelet adhesion and aggregation following a vascular injury is simulated in vitro. Platelet dysfunction detected by the PFA-100 system may be acquired, inherited or induced by platelet inhibiting agents. The PFA-100 system allows for rapid evaluation of platelet function on small samples of anticoagulated whole blood. The single use test cartridge reagents consists of a number of integrated parts including a capillary, a sample reservoir and a biologically active membrane with a central aperture. By application of a constant vacuum, anticoagulated whole blood is aspirated from the sample reservoir through the capillary and the aperture under standardized rheological conditions that expose platelets to high shear stress. The membrane is coated with collagen and one additional agonist. At the beginning of a test, Trigger Solution is dispensed to wet the membrane. Similar to the in vivo mechanism, platelets adhere and aggregate at the aperture thereby gradually diminishing and finally arresting the blood flow. The instrument determines the time from the start of the test until the platelet plug occludes the aperture, and reports that time interval as the Closure Time. Platelet plug formation in the PFA-100 system is dependent on adequate platelet activity and adequate von Willebrand factor status. Therefore, the Closure Time is an indicator of the platelet function in the analyzed whole blood sample.
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    K Number
    K973974
    Device Name
    DADE TRU-LIQUID CARDIAC CONTROL
    Manufacturer
    DADE INTL., INC.
    Date Cleared
    1997-11-06

    (17 days)

    Product Code
    JJT
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    DADE INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dade TRU-Liquid Cardiac Control is intended for use as an assayed quality control material in clinical laboratory quality assurance programs and to assist in the control of accuracy and precision of a laboratory's cardiac marker procedures.
    Device Description
    Dade® TRU-Liquid™ Cardiac Control Levels 1,2 and 3. Liquid Tri-Level Cardiac Control. Quality Control Material (Assayed and Unassayed).
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    K Number
    K973668
    Device Name
    CARDIAC TROPONIN-I (TROP) CALIBRATOR
    Manufacturer
    DADE INTL., INC.
    Date Cleared
    1997-10-20

    (25 days)

    Product Code
    JIT
    Regulation Number
    862.1150
    Why did this record match?
    Applicant Name (Manufacturer) :

    DADE INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cardiac Troponin-I Calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.
    Device Description
    The Cardiac Troponin-I (TROP) Calibrator is a five level frozen product with target concentrations of 0, 2, 8, 25, and 55 ng/mL containing cardiac troponin-l in a buffered bovine protein matrix. The kit consists of five vials; two at each level.
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    K Number
    K972524
    Device Name
    DRIED GRAM-POSITIVE MIC/COMBO PANELS
    Manufacturer
    DADE INTL., INC.
    Date Cleared
    1997-09-08

    (63 days)

    Product Code
    JWY
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    DADE INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To determine gram-positive bacterial susceptibility against the antimicrobial agent Sparfloxacin. Organisms with indications for testing* include: Sparfloxacin Gram-Positive Bacteria Staphylococcus aureus
    Device Description
    Microdilution Minimum Inhibitory Concentration (MIC) Panels
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    K Number
    K972782
    Device Name
    DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
    Manufacturer
    DADE INTL., INC.
    Date Cleared
    1997-08-15

    (21 days)

    Product Code
    JHX
    Regulation Number
    862.1215
    Why did this record match?
    Applicant Name (Manufacturer) :

    DADE INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Measurements of creatine kinase MB isoenzyme are used in the diagnosis and treatment of myocardial infaction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
    Device Description
    The Dade Stratus® CK-MB Fluorometric Enzyme Immunoassay is an in vitro diagnostic test for the MB isoenzyme of creatine kinase. The assay can be processed on the Stratus® analyzer, the Stratus® II analyzer or the Stratus® IIntellect analyzer.
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    K Number
    K972287
    Device Name
    DADE TRU-LIQUID BILIRUBIN CONTROL
    Manufacturer
    DADE INTL., INC.
    Date Cleared
    1997-07-07

    (18 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    DADE INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dade TRU-Liquid Bilirubin Control is intended for use as an assayed quality control material in clinical laboratory quality assurance programs and in the monitoring of accuracy and precision.in the clinical laboratory assay of ... .. bilirubin.
    Device Description
    Dade® TRU-Liquid™ Bilirubin Control Levels 1,2 and 3. Liquid Tri-Level Bilirubin Control. Quality Control Material (Assayed and Unassayed).
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    K Number
    K964660
    Device Name
    PARAMAX CHOLESTEROL REAGENT
    Manufacturer
    DADE INTL., INC.
    Date Cleared
    1997-06-04

    (196 days)

    Product Code
    CHH
    Regulation Number
    862.1175
    Why did this record match?
    Applicant Name (Manufacturer) :

    DADE INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For quantitative determination of cholesterol or HDL cholesterol in plasma or serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders'.
    Device Description
    The Paramax® Cholesterol Reagent and DuPont aca Cholesterol Reagent are based on colormetic methodology.
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    K Number
    K970676
    Device Name
    DRIED GRAM-NEGATIVE MIC/COMBO PANELS
    Manufacturer
    DADE INTL., INC.
    Date Cleared
    1997-05-02

    (67 days)

    Product Code
    JWY
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    DADE INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To determine antimicrobial agent susceptibility
    Device Description
    Microdilution Minimum Inhibitory Concentration (MIC) Panels, specifically MicroScan™ Dried Gram-Negative MIC/Combo Panels
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    K Number
    K964715
    Device Name
    PARAMAX SALICYLATE REAGENT
    Manufacturer
    DADE INTL., INC.
    Date Cleared
    1997-04-25

    (151 days)

    Product Code
    DKJ
    Regulation Number
    862.3830
    Why did this record match?
    Applicant Name (Manufacturer) :

    DADE INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Paramax® Salicylate Reagent is intended for use as quantitative determination of salicylate in plasma and serum.
    Device Description
    The Paramax® Salicylate Reagent is based on colormetric methodology.
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