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510(k) Data Aggregation

    K Number
    K963289
    Device Name
    INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY
    Manufacturer
    INCSTAR CORP.
    Date Cleared
    1997-05-01

    (253 days)

    Product Code
    LGD
    Regulation Number
    866.3780
    Why did this record match?
    Applicant Name (Manufacturer) :

    INCSTAR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INCSTAR Toxoplasma IgM Capture ELISA kit contains instructions and materials for the qualitative detection of IgM antibodies to Toxoplasma gondii in human serum by reverse capture enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the Toxoplasma IgM Capture ELISA test can be used as an aid in the diagnosis of current or recent active Toxoplasma gondii infection. This product is not FDA cleared for use in testing (i.e., screening) blood or plasma donors.
    Device Description
    The INCSTAR Toxoplasma IgM Capture ELISA Kit utilizes the enzyme-linked immunosorbent assay (ELISA) based on the antibody capture technique. Diluted patient serum is incubated with monoclonal mouse antibody against human IgM (u chain specific) bound to the solid surface of the microtiter well. : Patient IgM is "captured" by the surface bound antibody. The presence of patient anti-Toxoplasma IgM antibodies are then "detected" and bound by Toxoplasma antigen which is linked to an anti-Toxoplasma antibody conjugated to horseradish peroxidase. Bound horseradish peroxidase is reacted with chromogen, resulting in color development. The absorbance of the solution, measured at 450 nm / 630 nm, is directly proportional to the concentration of IgM to Toxoplasma antigen present in the reaction solution.
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    K Number
    K963296
    Device Name
    INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)
    Manufacturer
    INCSTAR CORP.
    Date Cleared
    1996-12-16

    (117 days)

    Product Code
    LGD
    Regulation Number
    866.3780
    Why did this record match?
    Applicant Name (Manufacturer) :

    INCSTAR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INCSTAR Toxoplasma IgG ELISA kit contains instructions and materials for qualitative and/or semi-quantitative detection of IgG antibodies to Toxoplasma gondii in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the Toxoplasma IgG ELISA is of value in the determination of immunological response to infection with Toxoplasma gondii. The evaluation of paired sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of primary or reactivated infection with Toxoplasma gondii. This product is not FDA cleared for use in testing (i.e., screening) blood or plasma donors.
    Device Description
    The method for the determination of specific anti-Toxoplasma IgG utilizes the enzyme-linked immunosorbent assay (ELISA) technique. Polystyrene microtiter wells are coated with purified Toxoplasma gondii antigen. Diluted patient serum is incubated with the purified antigen bound to the solid surface of a microtiter well. The Toxoplasma IgG antibodies present in a patient's serum will be captured by the solid phase. After washing, affinity purified polyclonal goat antihuman IgG (Fc) antibodies conjugated to horseradish peroxidase are added to the well. After this incubation, chromogen containing tetramethylbenzidine is added. Enzyme action on the chromogen results in a color reaction. The color can be detected with a photometer at a dual wavelength of 450 nm / 630 nm. The measured enzyme activity is directly proportional to the concentration of specific anti-Toxoplasma IqG bound to the solid phase.
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    K Number
    K963297
    Device Name
    INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)
    Manufacturer
    INCSTAR CORP.
    Date Cleared
    1996-12-16

    (117 days)

    Product Code
    LGD
    Regulation Number
    866.3780
    Why did this record match?
    Applicant Name (Manufacturer) :

    INCSTAR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INCSTAR Toxoplasma IgG "fast" ELISA kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgG antibodies to Toxoplasma gondii in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the Toxoplasma IqG "fast" ELISA test is of value in the determination immunological response to infection with Toxoplasma gondii. The evaluation of paired sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of primary or reactivated infection with Toxoplasma gondii. This product is not FDA cleared for use in testing (i.e., screening) blood or plasma donors.
    Device Description
    The method for the determination of specific anti-Toxoplasma IgG utilizes the enzyme-linked immunosorbent assay (ELISA) technique. Polystyrene microtiter wells are coated with purified Toxoplasma gondii antigen. Diluted patient serum is incubated with the purified antigen bound to the solid surface of a microtiter well. The Toxoplasma IgG antibodies present in a patient's serum will be captured by the solid phase. After washing, affinity purified polyclonal goat antihuman IgG (Fc) antibodies conjugated to horseradish peroxidase are added to the well. After this incubation, chromogen containing tetramethylbenzidine is added. Enzyme action on the chromogen results in a color reaction. The color can be detected with a photometer at a dual wavelength of 450 nm / 630 nm. The measured enzyme activity is directly proportional to the concentration of specific anti-Toxoplasma IgG bound to the solid phase.
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    K Number
    K960358
    Device Name
    INCSTAR RUBELLA IGG FAST ELISA ASSAY
    Manufacturer
    INCSTAR CORP.
    Date Cleared
    1996-10-24

    (273 days)

    Product Code
    LFX
    Regulation Number
    866.3510
    Why did this record match?
    Applicant Name (Manufacturer) :

    INCSTAR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INCSTAR Rubella IgG "fast" ELISA Kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgG antibodies to rubella in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the Rubella IgG "fast" ELISA test is of value in the determination of rubella immunological status. The evaluation of paired sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of current or recent infection with rubella.
    Device Description
    The INCSTAR Rubella IgG "fast" ELISA test kit utilizes the ELISA technique for the detection of rubella IgG antibodies. Diluted patient serum is incubated with purified rubella antigen bound to the solid surface of a microtiter well. If IgG antibodies to rubella are present in the patient's serum, antigen-antibody complexes are formed. These complexes bind with horseradish peroxidase labeled antihuman IgG which react with the addition of chromogen, resulting in color development. The absorbance of the solution, measured at 450 nm, is directly proportional to the concentration of IgG antibodies to rubella antigen present in the reaction solution.
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    K Number
    K960367
    Device Name
    INCSTAR RUBELLA IGG ELISA ASSAY
    Manufacturer
    INCSTAR CORP.
    Date Cleared
    1996-10-24

    (273 days)

    Product Code
    LFX
    Regulation Number
    866.3510
    Why did this record match?
    Applicant Name (Manufacturer) :

    INCSTAR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INCSTAR Rubella IgG ELISA Kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgG antibodies to rubella in human serum by indirect enzyme-linked immunosorbent assay (ELISA) - all technique. When performed according to instructions, the Rubella IgG ELISA test is of value in the determination of rubella immunological status. The evaluation of paired sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of current or recent infection with rubella.
    Device Description
    The INCSTAR Rubella IgG ELISA test kit utilizes the ELISA technique for the detection of rubella IgG antibodies. Diluted patient serum is incubated with purified rubella antigen bound to the solid surface of a microtiter well. If IgG antibodies to rubella are present in the patient's serum, antigen-antibody complexes are formed. These complexes bind with horseradish peroxidase labeled antihuman IgG which react with the addition of chromogen, resulting in color development. The absorbance of the solution, measured at 450 nm, is directly proportional to the concentration of IgG antibodies to rubella antigen present in the reaction solution.
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    K Number
    K960434
    Device Name
    INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530
    Manufacturer
    INCSTAR CORP.
    Date Cleared
    1996-10-17

    (260 days)

    Product Code
    LFZ
    Regulation Number
    866.3175
    Why did this record match?
    Applicant Name (Manufacturer) :

    INCSTAR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INCSTAR CMV IgM Capture ELISA Kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgM antibodies to cytomegalovirus in human serum by reverse capture enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the CMV IgM Capture ELISA test can be used as an aid in the diagnosis of current or recent active CMV infection. The evaluation of paired CMV IgM sera can also aid in determining the stage of active CMV infection.
    Device Description
    The INCSTAR CMV IgM Capture ELISA test kit utilizes the enzyme-linked immunosorbent assay (ELISA) based on the antibody capture technique. Diluted patient serum is incubated with mouse monoclonal antibody against human IgM (u chain specific) bound to the solid surface of a microtiter well. Patient IgM is "captured" by the surface bound antibody. The presence of patient anti-CMV IgM antibodies are then "detected" and bound by CMV antigen which is linked to an anti-CMV monoclonal antibody conjugated to horseradish peroxidase. Bound horseradish peroxidase is reacted with chromogen, resulting in color development. The absorbance of the solution, measured at 450 nm, is directly proportional to the concentration of IgM to CMV antigen present in the reaction solution
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    K Number
    K953567
    Device Name
    INCSTAR 25-HYDROXYVITMIN D 1251 RIA
    Manufacturer
    INCSTAR CORP.
    Date Cleared
    1996-09-25

    (422 days)

    Product Code
    MRG
    Regulation Number
    862.1825
    Why did this record match?
    Applicant Name (Manufacturer) :

    INCSTAR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INCSTAR 25-Hydroxyvitamin D 1251 RIA Kit is intended for the quantitative measurement of 25-hydroxyvitamin D and other hydroxylated vitamin D metabolites in human serum or plasma to be used in the assessment of vitamin D sufficiency.
    Device Description
    This assay requires serum or plasma samples to be extracted with acetonitrile to free vitamin D and its metabolites which are almost completely associated with binding proteins as well as remove lipids which would interfere with the assay. Calibrators (kit standards) containing known concentrations of 25hydroxycholecalciferol (25-OH Vitamin D3) in a human serum matrix are likewise extracted. The primary antibody (goat anti-25-OH vitamin D) selected for use in the assay demonstrates high affinity and equal cross-reactivity to both 25(OH)D2 and 25(OH)Da but very low cross-reactivity to non-hydroxylated vitamin D2 or D3 and 1.25(OH)2 D. The primary antiserum used in the assay does recognize several other dihvdroxylated metabolites of vitamin D; however, these metabolites are found in relatively low concentrations in the circulation and are believed to be of minor biological importance. During the assay reaction, samples compete with an 1251 labeled analog of 25-OH D3 for binding sites on the primary antiserum. Phase separation is accomplished using a donkey anti-goat, polyethylene glycol precipitating reagent. The amount of radioactivity contained in the resulting precipitate is inversely proportional to the concentration of 25-OH-D present in the sample.
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    K Number
    K955362
    Device Name
    INCSTAR HSV I/II IGG FAST ELISA ASSAY
    Manufacturer
    INCSTAR CORP.
    Date Cleared
    1996-07-24

    (245 days)

    Product Code
    IGC
    Regulation Number
    864.4010
    Why did this record match?
    Applicant Name (Manufacturer) :

    INCSTAR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INCSTAR Herpes Simplex Virus I/II IgG "fast" ELISA kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgG antibodies to herpes simplex virus type 1 and/or type 2 in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the INCSTAR Herpes Simplex Virus I/II IgG "fast" ELISA test is of value in the determination of immunological response to infection with HSV. The evaluation of paired sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of primary infection with herpes simplex virus.
    Device Description
    The method for the determination of specific anti-HSV type 1 and/or type 2 IgG utilizes the enzyme-linked immunosorbent assay (ELISA) technique. Polystyrene microtiter wells are coated with purified HSV type 1 and type 2 antigens. Diluted patient serum is incubated with the purified HSV antigens bound to the solid surface of the microtiter well. The HSV type 1 and/or type 2 IgG antibodies present in a patient's serum will be captured by the solid phase. After washing, affinity purified polyclonal goat anti-human IgG (Fc) antibodies conjugated to horseradish peroxidase are added to the well. After this incubation, chromogen containing tetramethylbenzidine is added. Enzyme action on the chromogen results in a color reaction. The color can be detected with a photometer at a wavelength of 450 nm. The measured enzyme activity is directly proportional to the concentration of specific anti-HSV IgG bound to the solid phase.
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    K Number
    K955363
    Device Name
    INCSTAR HSZ I/II IGG ELISA ASSAY
    Manufacturer
    INCSTAR CORP.
    Date Cleared
    1996-07-24

    (245 days)

    Product Code
    IGC
    Regulation Number
    864.4010
    Why did this record match?
    Applicant Name (Manufacturer) :

    INCSTAR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    Not Found
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    K Number
    K955360
    Device Name
    INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY
    Manufacturer
    INCSTAR CORP.
    Date Cleared
    1996-07-22

    (243 days)

    Product Code
    LFZ
    Regulation Number
    866.3175
    Why did this record match?
    Applicant Name (Manufacturer) :

    INCSTAR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INCSTAR CMV IgG "fast" ELISA Kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgG antibodies to cytomegalovirus in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the CMV IgG "fast" ELISA test is of value in the determination of immunological response to infection with CMV. The evaluation of paired sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of primary infection, reactivated infection, or reinfection with cytomegalovirus.
    Device Description
    The INCSTAR CMV IgG "fast" ELISA test kit utilizes the enzyme-linked immunosorbant assay (ELISA) technique for the detection of cytomegalovirus IgG antibodies. Polystyrene microtiter wells are coated with purified CMV antigen. Diluted patient serum is incubated with purified CMV antigen bound to the solid surface of a microtiter well. The CMV antibodies that are present in the patient's serum will be captured by the solid phase. After washing, these complexes bind with horseradish peroxidase labeled antihuman IgG which react with the addition of chromogen (tetramethylbenzidine), resulting in color development. The absorbance of the solution, measured at 450 nm, is directly proportional to the concentration of IgG antibodies to CMV antigen present in the reaction solution.
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