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510(k) Data Aggregation

    K Number
    K972342
    Device Name
    REAADS PROTEIN C ANTIGEN TEST KIT
    Date Cleared
    1997-10-06

    (104 days)

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

    REAADS MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The REAADS Protein C Antigen Test Kit is an in vitro diagnostic assay for the quantitative determination of plasma levels of human Protein C (as a percent of normal concentration) by enzyme linked immunosorbent assay (ELISA). Plasma levels of Protein C may be used in conjunction with other assays as an aid in diagnosing congenital or acquired Protein C deficiencies associated with thrombotic disease.
    Device Description
    The REAADS Protein C Antigen Test Kit is a sandwich enzyme linked immunosorbent assay (ELISA). The capture antibody specific for human Protein C is coated to 96 microwell polystyrene plate. Diluted patient plasma is incubated in the wells, allowing any available Protein C to bind to the anti-human Protein C antibody bound to the plastic. The plates are washed to remove any unbound Protein C or other plasma molecules. Bound Protein C is quantitated using an HRP conjugated anti-human Protein C detection antibody. Any unbound conjugated anti-human Protein C is washed away after an incubation period. A chromogenic substrate of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) is added to develop a colored reaction. The intensity of the color is measured spectrophotometrically at 450nm in optical density (O.D.) units. Protein C Antigen relative percent concentrations in patient plasma is determined against a curve made from a reference plasma.
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    K Number
    K972005
    Device Name
    REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT
    Date Cleared
    1997-08-13

    (75 days)

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

    REAADS MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The REAADS von Willebrand Factor Antigen (vWF:Ag) Test kit is an in vitro diagnostic assay for the quantitative determination of human plasma levels of vWF:Ag (as a percent assay to throncentration) by enzyme linked immunosorbent assay (ELISA). Plasma levels of vWF:Ag may be used as an aid in diagnosing von Willebrand disease.
    Device Description
    The REAADS von Willebrand Factor Antigen Test Kit is a sandwich enzyme linked immunosorbent assay (ELISA). The capture antibody specific for human vWF is immobilized to 96-microwell polystyrene plates. Diluted patient plasma is incubated in the wells, allowing any available vWF:Ag to bind to the anti-human vWF antibody bound to the plastic. The plates are rinsed to remove any unbound plasma vWF:Ag molecules. Bound vWF:Ag is quantitated using an HRP conjugated anti-human vWF detection antibody. Any unbound conjugated anti-human vWF is washed away after an incubation period. A chromogenic substrate of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) is added to develop a colored reaction. The intensity of the color is measured spectrophotometrically at 450nm in optical density (O.D.) units. vWF:Ag relative percent concentrations of patient plasma is determined against a curve made from a reference plasma provided.
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    K Number
    K972482
    Device Name
    REAADS PROTEIN S ANTIGEN TEST KIT
    Date Cleared
    1997-08-13

    (42 days)

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

    REAADS MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The REAADS Protein S Antigen Test Kit is an in vitro diagnostic assay for the quantitative determination of Total and Free Protein S levels in human plasma (as a percentration) by enzyme-linked immunosorbent assay (ELISA). Plasma levels of Protein S may be used in conjunction with the results from other assays as an aid in diagnosing congenital or acquired Protein S deficiencies associated with thrombotic disease.
    Device Description
    The REAADS Protein S Antigen Test Kit is a sandwich enzyme linked immunosorbent assay (ELISA). A capture antibody specific for human Protein S is coated to 96-microwell polystyrene plate. Diluted patient plasma is incubated in the wells, allowing any available Protein S to bind to the anti-human Protein S antibody on the microwell surface. The plates are washed to remove any unbound plasma molecules. Bound Protein S is quantitated using an HRP conjugated anti-human Protein S detection antibody. Any unbound conjugated antihuman Protein S is washed away after an incubation period. A chromogenic substrate of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) is added to develop a colored reaction. The intensity of the color is measured spectrophotometrically at 450nm in optical density (O.D.) units. Protein S relative percent concentrations in patient plasma are determined against a curve prepared from a reference plasma provided with the kit. Results obtained from diluted plasma samples not pretreated with polyethylene glycol (PEG) represent the Total Protein S concentration from that sample. To measure Free Protein S, PEG is added to plasma samples prior to beginning the assay to precipitate the Protein S-C4b binding protein complex. The supernatant fraction containing Free Protein S may be tested along with the untreated plasma sample. Both Total (untreated) and Free (PEG-treated) Protein S concentrations are determined following the same assay procedure described using separate reference curves.
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