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510(k) Data Aggregation

    K Number
    K080069
    Device Name
    DIMERTEST
    Manufacturer
    AMERICAN DIAGNOSTICA, INC.
    Date Cleared
    2008-02-13

    (34 days)

    Product Code
    DAP
    Regulation Number
    864.7320
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN DIAGNOSTICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DIMERTEST® Latex Assay is intended for the rapid qualitative or semi-quantitative evaluation of circulating derivatives of cross-linked fibrin degradation products (D-dimer) in human plasma.
    Device Description
    The DIMERTEST® Latex Kit is a qualitative and semi-quantitative latex agglutination slide test for cross-linked fibrin degradation products in human plasma. The active ingredient in the DIMERTEST® product is the latex reagent. This reagent consists of highly specific D-dimer monoclonal antibodies attached to polystyrene latex particles. When mixed with the latex reagent, the presence of antigen (Ddimer) in a plasma sample results in agglutination of the latex particles which can be seen with the unaided eye. A semi-quantitative estimate of the Ddimer concentration can be made by preparing dilutions of a plasma sample. The concentration is determined according to a titration matrix. Plasma from normal individuals is not expected to agglutinate DIMERTEST® Latex. Reactive fibrinolysis will be demonstrated by latex agglutination at a plasma concentration of approximately 200 ng/mL D-dimer.
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    K Number
    K063323
    Device Name
    SPECTROLYSE PAI-1, MODEL 101201
    Manufacturer
    AMERICAN DIAGNOSTICA, INC.
    Date Cleared
    2007-08-15

    (285 days)

    Product Code
    GGP
    Regulation Number
    864.7290
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN DIAGNOSTICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Spectrolyse ® PAI-1 kit, Product # 101201, is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity in human plasma. The test is for in vitro diagnostic use and is not intended for internal use in humans and animals.
    Device Description
    Spectrolyse @ PAI-1 is a two stage colorimetric assay. The first stage involves incubating samples with a known amount of tPA, allowing PAI-1 in the sample to react with tPA. In the second stage, the residual tPA activity converts plasminogen to plasmin, which in turn hydrolyzes a plasmin chromogenic substrate, SPECTROZYME® PL. PAI-1 in the plasma is determined as the difference between the amount of tPA added and the amount of tPA recovered.
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    K Number
    K052124
    Device Name
    ACTICLOT, MODEL 824
    Manufacturer
    AMERICAN DIAGNOSTICA, INC.
    Date Cleared
    2005-10-17

    (73 days)

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

    AMERICAN DIAGNOSTICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACTICLOT® dPT™ is intended for the qualitative determination of lupus anticoagulants (LA) in human plasma. This test is for in vitro diagnostic use.
    Device Description
    ACTICLOT® dPT" is a test kit. It has three reagents that are used selectively for a screening protocol and a confirmatory protocol. LA Buffer" is used with dPT Activator" for the screening protocol. LA Phospholipids" is used with dPT Activator" for the confirmatory protocol. ACTICLOT® dPT" is a professional use qualitative test.
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    K Number
    K013637
    Device Name
    ACTICHROME HEPARIN (ANTI-FIIA)
    Manufacturer
    AMERICAN DIAGNOSTICA, INC.
    Date Cleared
    2002-04-16

    (162 days)

    Product Code
    KFF
    Regulation Number
    864.7525
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN DIAGNOSTICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ACTICHROME® Heparin (anti-fila) is a chromogenic assay intended for the quantitative determination of therapeutic heparin in human plasma by measurement of factor IIa (thrombin) inhibition. The Electra 900C® was used to determine performance data. This kit is for in vitro diagnostic use.
    Device Description
    ACTICHROME® Heparin (anti-fIIa) Product No. 820
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    K Number
    K013492
    Device Name
    IMUBIND TPA ELISA, MODEL 860
    Manufacturer
    AMERICAN DIAGNOSTICA, INC.
    Date Cleared
    2002-03-13

    (142 days)

    Product Code
    GGP
    Regulation Number
    864.7290
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN DIAGNOSTICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IMUBIND® tPA ELISA is an enzyme-linked immunosorbent assay for the measurement of human tissue-type Plasminogen Activator (tPA) antigen in plasma. This kit is for in vitro diagnostic use. Levels of tPA in plasma are known to be elevated in late stage pregnancy, myocardial infarction, atherosclerosis, and stroke.
    Device Description
    IMUBIND® tPA ELISA is an enzyme-linked immunosorbent assay for the measurement of human tissue-type Plasminogen Activator (tPA) antigen in plasma.
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    K Number
    K013318
    Device Name
    ACTICHROME HEPARIN (ANTI-FXA), MODEL 832
    Manufacturer
    AMERICAN DIAGNOSTICA, INC.
    Date Cleared
    2002-03-08

    (154 days)

    Product Code
    KFF
    Regulation Number
    864.7525
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN DIAGNOSTICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ACTICHROME® Heparin (anti-fXa) is a chromogenic assay intended for the quantitative determination of unfractionated and low molecular weight heparins in human plasma. The assay measures the inhibition of factor Xa (fXa) activity by the various heparins. The Electra 900C® was used to determine performance data. This kit is for in vitro diagnostic use.
    Device Description
    ACTICHROME® Heparin (anti-fXa) is a chromogenic assay intended for the quantitative determination of unfractionated and low molecular weight heparins in human plasma. The assay measures the inhibition of factor Xa (fXa) activity by the various heparins.
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    K Number
    K013168
    Device Name
    IMUBIND PLASMA PAI-1 ELISA,MODEL 822
    Manufacturer
    AMERICAN DIAGNOSTICA, INC.
    Date Cleared
    2002-03-07

    (167 days)

    Product Code
    GGP
    Regulation Number
    864.7290
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN DIAGNOSTICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IMUBIND® Plasma PAI-1 ELISA is an enzyme-linked immunosorbent assay for the measurement of Plasminogen Activator Inhibitor Type-1 (PAI-1) antigen in human plasma. This kit is for in vitro diagnostic use. High levels of PAI-1 antigen are known to be associated with deep vein thrombosis and myocardial infarction.
    Device Description
    The IMUBIND® Plasma PAI-1 ELISA is an enzyme-linked immunosorbent assay for the measurement of Plasminogen Activator Inhibitor Type-1 (PAI-1) antigen in human plasma. All plate wells contain antibody to PAI-1.
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    K Number
    K012386
    Device Name
    ACTICLOT PROTEIN S, MODEL 843L
    Manufacturer
    AMERICAN DIAGNOSTICA, INC.
    Date Cleared
    2001-09-14

    (49 days)

    Product Code
    GGP
    Regulation Number
    864.7290
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN DIAGNOSTICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACTICLOT® Protein S clotting assay is an in vitro diagnostic device intended for the quantitative determination of Protein S activity in human plasma. Protein S activity levels in plasma are known to be low in patients with congenital Protein S deficiencies type-I, type-IIb, and type-IIb, and may also be low in pregnant I fotom & donemelers with liver disease and in inflammatory disease in which levels of C4b wonline in patients with are elevated. A decrease in Protein S activity is associated with an increased incidence of thromboembolism.
    Device Description
    ACTICLOT Protein S is an in vitro diagnostic clotting assay for the quantitative determination of Protein S activity in human plasma.
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