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510(k) Data Aggregation

    K Number
    K100179
    Device Name
    SPAPLUS
    Manufacturer
    THE BINDING SITE GROUP, LTD.
    Date Cleared
    2010-08-13

    (204 days)

    Product Code
    CZW
    Regulation Number
    866.5240
    Why did this record match?
    Product Code :

    CZW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This kit is intended for the quantitative in vitro determination of human C3c in serum using the Binding Site SPAPLUS™ turbidimetric analyser. This test should be used in conjunction with other laboratory and clinical findings.
    Device Description
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    K Number
    K063150
    Device Name
    COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL
    Manufacturer
    THERMO ELECTRON OY
    Date Cleared
    2007-03-19

    (154 days)

    Product Code
    CZW, DBI, JIX, JJY
    Regulation Number
    866.5240
    Why did this record match?
    Product Code :

    CZW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use in the quantitative determination of the complement C3 concentration in human serum on the T60 analyzer. For in vitro diagnostic use in the quantitative determination of the complement C4 concentration in human serum on the T60 analyzer. The complement C3 and complement C4 are intended for quantative in-vitro diagnostic determination of the complement C3 and C4 concentration in human serum using T60 Clinical Chemistry Analyzers. C3 and C4 measurements may aid in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.
    Device Description
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    K Number
    K061852
    Device Name
    DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2006-09-22

    (84 days)

    Product Code
    CZW, DBI, JIX, JJY
    Regulation Number
    866.5240
    Why did this record match?
    Product Code :

    CZW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dimension Vista™ C3 Flex® reagent cartridge: The C3 method is an in vitro diagnostic test for the quantitative measurement of complement C3 in human serum and heparinized plasma on the Dimension Vista™ System. Measurements of C3 are used as an aid in the diagnosis of immunologic disorders associated with complement C3 protein. Dimension Vista™ C4 Flex® reagent cartridge: The C4 method is an in vitro diagnostic test for the quantitative measurement of complement C4 in human serum and heparinized plasma on the Dimension Vista™ System. Measurements of C4 are used as an aid in the diagnosis of immunologic disorders associated with complement C4 protein. Dimension Vista™ Protein 1 Calibrator: Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), and Immunoglobulin M (IGM) on the Dimension Vista™ System. Dimension Vista™ Protein 1 Control L, Dimension Vista™ Protein 1 Control M and Dimension Vista™ Protein 1 Control H: Protein 1 Control L/M/H are for use as an assayed intralaboratory quality controls for the assessment of precision and analytical bias in determination of C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM) methods on the Dimension Vista™ System.
    Device Description
    Dimension Vista™ C3 and C4 Flex® reagent cartridges: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a calibrator of known concentration. Dimension Vista™ Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing, C3 Complement, C4 Complement, Immunoglobulin A, Immunoglobulin G and lmmunoqlobulin M (IGM). Dimension Vista™ Protein 1 Controls L/M/H: Protein 1 Controls L/M/H are multi-analyte, liquid human serum based products containing C3 Complement, C4 Complement, Immunoglobulin A, Immunoglobulin G and lmmunoglobulin M (IGM).
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    K Number
    K050665
    Device Name
    N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2005-05-02

    (48 days)

    Product Code
    CZW, DBI
    Regulation Number
    866.5240
    Why did this record match?
    Product Code :

    CZW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In vitro diagnostic reagents for the quantitative determination of complement factors (C3/C3c and C4/C4c) in human serum or heparinized or EDTA plasma by means of immunonephelometry on the BN* Systems as an aid in the diagnosis of immunologic disorders associated with complement C3 or C4 protein.
    Device Description
    Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific, purified rabbit antibodies to human C3 and C4.
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    K Number
    K042494
    Device Name
    VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Date Cleared
    2004-10-19

    (35 days)

    Product Code
    CZW, DBI, JIT, JJX
    Regulation Number
    866.5240
    Why did this record match?
    Product Code :

    CZW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use only. VITROS Chemistry Products C3 Reagent is used to quantitatively measure complement C3 (C3) concentration in human serum and plasma. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components. For in vitro diagnostic use. VITROS Chemistry Products Calibrator Kit 20 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM. For in vitro diagnostic use only. VITROS Chemistry Products Protein Performance Verifiers are assayed controls used to monitor the performance of TRFRN, C3, C4, IgA, IgG and IgM Reagents on VITROS 5,1 FS Chemistry Systems. For in vitro diagnostic use only. VITROS Chemistry Products C4 Reagent is used to quantitatively measure complement C4 (C4) concentration in human serum and plasma. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.
    Device Description
    The VITROS 5,1 FS Chemistry System is a fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human specimens (serum, plasma, urine, and cerebrospinal fluid). The VITROS 5,1 FS System is designed for use with VITROS Chemistry Products MicroTip and Thin Film assays. The system is comprised of four main elements: 1. The VITROS 5,1 FS Chemistry System instrumentation, which provides automated use of the chemistry reagents. 2. The VITROS Chemistry Products MicroTip range of liquid reagent products (in this case VITROS Chemistry Products C3 Reagent, VITROS Chemistry Products C4 Reagent, VITROS Chemistry Products Calibrator Kit 20 and VITROS Chemistry Products Protein Performance Verifiers I, II and III), which are combined on the VITROS 5,1 FS Chemistry System to perform the VITROS C3 and C4 assays. 3. The VITROS Chemistry Products Thin Film range of dry products, which are dry, multilayered, analytical elements, coated on polyester supports. 4. Common reagents used by multiple assays on the VITROS System (in this case, VITROS Chemistry Products FS Diluent Pack 2). The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
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    K Number
    K032796
    Device Name
    IBL C3D-CIC EIA TEST
    Manufacturer
    IBL GMBH
    Date Cleared
    2004-01-13

    (127 days)

    Product Code
    CZW
    Regulation Number
    866.5240
    Why did this record match?
    Product Code :

    CZW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IBL C3d-CIC test is a semi-quantitative enzyme immunoassay for the in vitro diagnostic detection of circulating immune complex that bind C3d in human serum. The measurement is performed as an aid in the diagnosis of various autoimmune and other CIC related diseases. Levels of these complexes are one indicator in a multi-factorial diagnostic regime.
    Device Description
    semi-quantitative enzyme immunoassay for the in vitro diagnostic detection of circulating immune complex that bind C3d in human serum.
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    K Number
    K032035
    Device Name
    SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI
    Manufacturer
    BECKMAN COULTER, INC.
    Date Cleared
    2003-08-07

    (37 days)

    Product Code
    CZW, DBI, JIT
    Regulation Number
    866.5240
    Why did this record match?
    Product Code :

    CZW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    C3 reagent, when used in conjunction with SYNCHRON LX® Systems and Calibrator 1, is intended for quantitative determination of Complement C3 concentration in human serum or plasma by rate turbidimetry. C4 reagent, when used in conjunction with SYNCHRON LX® Systems and Calibrator 1, is intended for quantitative determination of Complement C4 concentration in human serum or plasma by turbidimetry. The Beckman Coulter SYNCHRON LX® Systems Calibrator 1 (CAL 1), used in conjunction with SYNCHRON LX reagents, is intended for the calibration of the immunoprotein tests on SYNCHRON LX Systems.
    Device Description
    The SYNCHRON LX® C3 and C4 Reagents are designed for optimal performance on the SYNCHRON LX® Systems. The reagent kit contains two 100-test cartridges that are packaged separately from the associated calibrators. The LX CAL 1 kit contains four 3 mL - bottles.
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    K Number
    K012361
    Device Name
    TINA-QUANT COMPLEMENT C3C TEST SYSTEM
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2001-11-29

    (127 days)

    Product Code
    CZW
    Regulation Number
    866.5240
    Why did this record match?
    Product Code :

    CZW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the in vitro quantitative immunological determination of human complement C3c in serum and plasma. Measurements of these proteins aid in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.
    Device Description
    The Tina-quant Complement C3c ver.2 Test System is based on the activation of the complement system which takes place via a classical and an alternative route. The two pathways come together in a joint terminal path. As a complement factor C3 is a factor common to both pathways, the concentration of C3 and its degradation products (including C3c) can be evaluated as a parameter for activation of the complement system. Human C3c forms a precipitate with a specific antiserum which is determined turbidimetrically.
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    K Number
    K010326
    Device Name
    WAKO AUTOKIT C3
    Manufacturer
    WAKO CHEMICALS, USA, INC.
    Date Cleared
    2001-06-25

    (143 days)

    Product Code
    CZW
    Regulation Number
    866.5240
    Why did this record match?
    Product Code :

    CZW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000469
    Device Name
    RANDOX COMPLEMENT C3
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Date Cleared
    2000-03-27

    (45 days)

    Product Code
    CZW
    Regulation Number
    866.5240
    Why did this record match?
    Product Code :

    CZW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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