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510(k) Data Aggregation

    K Number
    K242952
    Device Name
    INNOVANCE Antithrombin
    Manufacturer
    Siemens Healthcare Diagnostic Products GmbH
    Date Cleared
    2025-03-28

    (184 days)

    Product Code
    JBQ
    Regulation Number
    864.7060
    Why did this record match?
    Product Code :

    JBQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    INNOVANCE Antithrombin is a chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma and can be used as an aid in the diagnosis of antithrombin deficiency. INNOVANCE Antithrombin is indicated as an aid in monitoring antithrombin activity to support QFITLIA (fitusiran) dosing in adult and pediatric patients aged 12 years and older with hemophilia A or B with or without factor VIII or IX inhibitors.
    Device Description
    The INNOVANCE Antithrombin assay is suitable for the determination of physiologically active antithrombin on automatic analyzers and enables the diagnosis of inherited or acquired antithrombin deficiencies. The INNOVANCE Antithrombin assay utilizes a chromogenic measuring principle. An excess of human factor Xa is added to citrated plasma. In the presence of heparin, a portion of the enzyme is complexed and inactivated by the antithrombin present in the sample. Excess, uninhibited factor Xa then cleaves a specific chromogenic substrate, causing the release of a dye. The substrate cleavage is determined by the increase in the absorbance value at 405 nm. The release of dye is inversely proportional to the inhibiting activity of antithrombin in the plasma sample, i.e., the smaller the concentration of functionally active antithrombin, the higher the absorbance signal per time unit.
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    K Number
    K081769
    Device Name
    INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Date Cleared
    2009-05-28

    (339 days)

    Product Code
    JBQ
    Regulation Number
    864.7060
    Why did this record match?
    Product Code :

    JBQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    INNOVANCE™ Antithrombin is a chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma and can be used as an aid in the diagnosis of antithrombin deficiency.
    Device Description
    The INNOVANCE™ Antithrombin assay utilizes a chromogenic measuring principle. An excess of factor Xa is added to citrated plasma. In the presence of heparin, a portion of the enzyme is complexed and inactivated by the antithrombin present in the sample. Excess, uninhibited factor Xa then cleaves a specific chromogenic substrate, causing the release of a dye. The rate of the substrate cleavage is determined by the increase in the absorbance value at 405 nm.
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    K Number
    K070301
    Device Name
    HEMOSIL ANTITHROMBIN
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    2007-02-23

    (23 days)

    Product Code
    JBQ
    Regulation Number
    864.7060
    Why did this record match?
    Product Code :

    JBQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HemosIL Antithrombin is an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma to monitor the administration of heparin in the treatment of thrombosis and as an aid in the diagnosis of thrombophilia (a congenital deficiency of Antithrombin).
    Device Description
    HemosIL Antithrombin is an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma to monitor the administration of heparin in the treatment of thrombosis and as an aid in the diagnosis of thrombophilia (a congenital deficiency of Antithrombin).
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    K Number
    K062431
    Device Name
    HEMOSIL LIQUID ANTITHROMBIN
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    2006-09-01

    (11 days)

    Product Code
    JBQ
    Regulation Number
    864.7060
    Why did this record match?
    Product Code :

    JBQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HemosIL Liquid Antithrombin is an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency and to monitor Antithrombin substitution therapy.
    Device Description
    HemosIL Liquid Antithrombin is an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency and to monitor Antithrombin substitution therapy. This in vitro diagnostic test is based on a synthetic chromogenic substrate and on Factor Xa inactivation. As a consequence, it is specific and not influenced by Heparin Cofactor II. Antithrombin levels in patient plasma are measured automatically on IL Coagulation Systems.
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    K Number
    K043007
    Device Name
    BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105
    Manufacturer
    HYPHEN BIOMED
    Date Cleared
    2005-11-07

    (371 days)

    Product Code
    JBQ, 81J
    Regulation Number
    864.7060
    Why did this record match?
    Product Code :

    JBQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BIOPHEN Antithrombin 2.5 and 5 kit, is an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma, as an aid in the diagnosis of thrombophilia (a congenital deficiency of Antithrombin).
    Device Description
    Biophen Antithrombin 2.5 and 5 kit, an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma to monitor the Antithrombin concentration in human plasma, in instances of recurrent thrombosis resulting from a congenital or acquired deficiency of Antithrombin.
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    K Number
    K033775
    Device Name
    HEMOSIL LIQUID ANTITHROMBIN XL
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    2004-01-02

    (30 days)

    Product Code
    JBQ
    Regulation Number
    864.7060
    Why did this record match?
    Product Code :

    JBQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HemosIL Liquid Antithrombin XL is a modified version of HemosIL Liquid Antithrombin (K994238) with optimized reagent volumes for use on specific IL Coagulation Systems, such as the ACL Futura (K951891) and ACL Advance (K002400). This modification does not alter the fundamental scientific technology of the device or its intended use as an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency and to monitor Antithrombin substitution therapy. For in vitro diagnostic use.
    Device Description
    HemosIL Liquid Antithrombin XL is a modified version of HemosIL Liquid Antithrombin (K994238) with optimized reagent volumes for use on specific IL Coagulation Systems, such as the ACL Futura (K951891) and ACL Advance (K002400). This modification does not alter the fundamental scientific technology of the device or its intended use as an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency and to monitor Antithrombin substitution therapy.
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    K Number
    K023991
    Device Name
    CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50
    Manufacturer
    PRECISION BIOLOGIC
    Date Cleared
    2003-04-28

    (146 days)

    Product Code
    JBQ
    Regulation Number
    864.7060
    Why did this record match?
    Product Code :

    JBQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ChromoCheck™ Antithrombin is intended for use as an in vitro chromogenic assay for the quantitative determination of antithrombin activity in citrated human plasma.
    Device Description
    ChromoCheck™ Antithrombin is a chromogenic assay consisting of a synthetic substrate, Factor Xa, and a Tris Heparin Buffer
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    K Number
    K022550
    Device Name
    COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    2002-08-27

    (25 days)

    Product Code
    JBQ, JBO
    Regulation Number
    864.7060
    Why did this record match?
    Product Code :

    JBQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Coamatic® LR Antithrombin is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma. All components of the kit are in liquid formulation (LR = Liquid Reagents).
    Device Description
    Coamatic® LR Antithrombin is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma. All components of the kit are in liquid formulation (LR = Liquid Reagents). Antithrombin is the most important natural inhibitor of the coagulation cascade. By inhibiting the coagulation proteases, especially thrombin, factor Xa and factor IXa, antithrombin prevents uncontrolled coagulation and thrombosis. Plasma is incubated with an excess of Factor Xa (FXa) in the presence of heparin. The residual activity of FXa is determined by the rate of hydrolysis of the chromogenic substrate S-2772. The pNA release measured at 405 nm is inversely proportional to the AT level in the range 15-125% of normal plasma.
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    K Number
    K022195
    Device Name
    COAMATIC AT-400
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    2002-08-07

    (33 days)

    Product Code
    JBQ
    Regulation Number
    864.7060
    Why did this record match?
    Product Code :

    JBQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Coamatic® AT-400 is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma.
    Device Description
    Coamatic® AT-400 is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma. Antithrombin is the most important natural inhibitor of the coagulation cascade. Bv inhibiting the coagulation proteases, especially thrombin, factor Xa and factor IXa, antithrombin prevents uncontrolled coagulation and thrombosis. Plasma is incubated with an excess of Factor Xa (FXa) in the presence of heparin. The residual activity of FXa is determined by the rate of hydrolysis of the chromogenic substrate S-2772. The pNA release measured at 405 nm is inversely proportional to the AT level in the range 10-125% of normal plasma.
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    K Number
    K994238
    Device Name
    IL TEST LIQUID ANTITHROMBIN
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    2000-06-23

    (190 days)

    Product Code
    JBQ
    Regulation Number
    864.7060
    Why did this record match?
    Product Code :

    JBQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IL Test™ Liquid Antithrombin is an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency.
    Device Description
    IL Test™ Liquid Antithrombin is an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency. This in vitro diagnostic test is based on a synthetic chromogenic substrate and on Factor Xa inactivation. As a consequence, it is specific and not influenced by Heparin Cofactor II. Antithrombin levels in patient plasma are measured automatically on IL Coagulation Systems.
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