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510(k) Data Aggregation

    K Number
    K100227
    Device Name
    SAS FLUALERT A&B, SAS INFLUENZA A TEST
    Manufacturer
    SA SCIENTIFIC, INC.
    Date Cleared
    2010-02-23

    (28 days)

    Product Code
    PSZ, GNX
    Regulation Number
    866.3328
    Why did this record match?
    Applicant Name (Manufacturer) :

    SA SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SAS™ FluAlert A Test is a visual and rapid assay for the presumptive in-vitro qualitative detection of Influenza A viral nucleoprotein antigens from nasal washes and nasal aspirates of symptomatic patients. The test is not intended for the detection of Influenza Type B viral antigen or Influenza Type C viral antigen. This test is for professional use only. Negative results do not preclude infection with influenza A and should not be used as the sole basis for treatment or other patient management decisions. It is recommended that negative results be confirmed by cell culture.
    Device Description
    The SASTM FluAlert A Test utilizes antibodies against influenza type A viral nucleoproteins. The SASTM FluAlert A Test begins with an extraction of Type A nucleoproteins. After the extraction has been completed, the sample is placed into the sample well of the test. The specimen is absorbed and migrates via capillary action through membranes that contain dried gold conjugated antibody, which is specific for influenza A viral nucleoproteins. If these nucleoproteins are present, a "half-sandwich" immunocomplex is formed. The membrane contains immobilized antibody to influenza A nucleoproteins, which binds the "half sandwich" complex. Thus, in the presence of influenza A nucleoproteins, a "whole sandwich" immunocomplex is formed and a visible, pink-colored line develops in the specimen zone of the test device. In the absence of an influenza A antigen, a "sandwich" immunocomplex is not formed and a negative result is indicated. To serve as a procedural control, a pink-colored control line will always appear in the control zone of each strip regardless of the presence or absence of influenza A nucleoproteins.
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    K Number
    K080380
    Device Name
    SAS INFLUENZA A & B TEST
    Manufacturer
    SA SCIENTIFIC, INC.
    Date Cleared
    2009-07-23

    (526 days)

    Product Code
    PSZ, GNX
    Regulation Number
    866.3328
    Why did this record match?
    Applicant Name (Manufacturer) :

    SA SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SAS™ FluAlert A & B Test is a visual and rapid assay for the presumptive in-vitro qualitative detection of influenza A and influenza B viral nucleoprotein antigens from nasal washes and nasal aspirates of symptomatic patients. Negative results should be confirmed via culture. This test is not intended for the detection of Influenza Type C viral antigen. This test is for professional use only. Negative results do not preclude infection with influenza A or B and should not be used as the sole basis for treatment or other patient management decisions. It is recommended that negative results be confirmed by cell culture.
    Device Description
    The SAS™ FluAlert A & B Test utilizes antibodies against influenza type A and influenza type B viral nucleoproteins. After the extraction has been completed, the sample is placed into two separate sample wells. The specimen is absorbed and migrates via capillary action through membranes that contain dried gold conjugated antibody, which is specific for either influenza A or influenza B viral nucleoproteins. If these nucleoproteins are present, a "half-sandwich" immunocomplex is formed. The membrane contains immobilized antibody to influenza A or influenza B nucleoproteins, respectively, which bind the "half sandwich" complex. Thus, in the presence of influenza nucleoproteins, a "whole sandwich" immunocomplex is formed and a visible, pink-colored line develops in the specimen zone of the test device. In the absence of an influenza antigen, a "sandwich" immunocomplex is not formed and a negative result is indicated. To serve as a procedural control, a pink-colored control line will always appear in the control zone of each strip regardless of the presence or absence of influenza A or influenza B nucleoproteins.
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    K Number
    K041439
    Device Name
    SAS INFLUENZA B TEST
    Manufacturer
    SA SCIENTIFIC, INC.
    Date Cleared
    2004-07-22

    (51 days)

    Product Code
    PSZ, GNX
    Regulation Number
    866.3328
    Why did this record match?
    Applicant Name (Manufacturer) :

    SA SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SAS™ Influenza B Test is a visual and rapid assay for the presumptive qualitative detection of Influenza Type B antigens from nasal washes and aspirates. Negative results should be confirmed via culture. This test is not intended for the detection of Influenza Type A or C viral antigen. The test is for professional use.
    Device Description
    The SAS™ Influenza B test utilizes a set monoclonal antibodies against Influenza Type B viral nucleoproteins. The SAS™ Influenza test begins with an extraction of Type B nucleoproteins. After the extraction has been completed, the sample is placed into the test and observed for the formation of colored lines. The specimen is absorbed and migrates via capillary action through a membrane that contains dried gold conjugated antibody, which is specific for Influenza Type B nucleoproteins. If Type B nucleoproteins are present, a "half-sandwich" immuno-complex is formed. The membrane contains immobilized antibody to Influenza Type B nucleoproteins, which binds the "half sandwich" complex. Thus, in the presence of Influenza nucleoproteins, a "whole sandwich" immuno-complex is formed and a visible, pink colored line develops in the specimen zone of the test device. In the absence of an Influenza antigen, a "sandwich" immuno-complex is not formed and a negative result is indicated. To serve as a procedural control, a pink colored control line will always appear in the control zone regardless of the presence or absence of Influenza B nucleoproteins.
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    K Number
    K041441
    Device Name
    SAS INFLUENZA A TEST
    Manufacturer
    SA SCIENTIFIC, INC.
    Date Cleared
    2004-07-22

    (51 days)

    Product Code
    PSZ, GNX
    Regulation Number
    866.3328
    Why did this record match?
    Applicant Name (Manufacturer) :

    SA SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SAS™ Influenza A Test is a visual and rapid assay for the presumptive qualitative detection of Influenza Type A antigens from nasal washes and aspirates. Negative results should be confirmed via culture. This test is not intended for the detection of Influenza Type B or C viral antigen. The test is for professional use.
    Device Description
    The SASTM Influenza A test utilizes a set monoclonal antibodies against Influenza Type A viral nucleoproteins. The SASTM Influenza test begins with an extraction of Type A nucleoproteins. After the extraction has been completed, the sample is placed into the test and observed for the formation of colored lines. The specimen is absorbed and migrates via capillary action through a membrane that contains dried gold conjugated antibody, which is specific for Influenza Type A nucleoproteins. If Type A nucleoproteins are present, a "half-sandwich" immuno-complex is formed. The membrane contains immobilized antibody to Influenza Type A nucleoproteins, which binds the "half sandwich" complex. Thus, in the presence of Influenza nucleoproteins, a "whole sandwich" immuno-complex is formed and a visible, pink colored line develops in the specimen zone of the test device. In the absence of an Influenza antigen, a "sandwich" immuno-complex is not formed and a negative result is indicated. To serve as a procedural control, a pink colored control line will always appear in the control zone regardless of the presence or absence of Influenza nucleoproteins.
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    K Number
    K030628
    Device Name
    SAS RSV CONTROL KIT
    Manufacturer
    SA SCIENTIFIC, INC.
    Date Cleared
    2003-03-17

    (18 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    SA SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SAS™ RSV Control Kit are controls for use with the SAS™ RSV Test Kit. The test is for professional use.
    Device Description
    Not Found
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    K Number
    K022845
    Device Name
    SAS RSV TEST
    Manufacturer
    SA SCIENTIFIC, INC.
    Date Cleared
    2003-01-29

    (155 days)

    Product Code
    GQG
    Regulation Number
    866.3480
    Why did this record match?
    Applicant Name (Manufacturer) :

    SA SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SAS™ RSV antigen test kit is a visual and rapid assay for the qualitative detection of Respiratory Syncytial Virus (RSV) antigen directly from nasopharyngeal specimens. The test is for professional use.
    Device Description
    Not Found
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    K Number
    K022683
    Device Name
    SAS BLOOD/SERUM/URINE/URINE HCG
    Manufacturer
    SA SCIENTIFIC, INC.
    Date Cleared
    2002-12-16

    (126 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    SA SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SASTM Blood/Serum/Urine hCG is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in whole blood, serum or urine to aid in the early detection of pregnancy. The test is for professional use.
    Device Description
    The SAS Blood/Serum/Urine Test utilizes the same antibodies and 90% of the same test construction of the Modified SAS Serum/Urine test. The most significant difference in the SAS Blood/Serum/Test is that it utilizes a red blood cell separation media that separates plasma from the whole blood cell component.
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    K Number
    K023270
    Device Name
    SAS STREPALERT
    Manufacturer
    SA SCIENTIFIC, INC.
    Date Cleared
    2002-10-17

    (16 days)

    Product Code
    GTY
    Regulation Number
    866.3740
    Why did this record match?
    Applicant Name (Manufacturer) :

    SA SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SASTM StrepAlert is a rapid visual test for the presumptive, qualitative detection of group A streptococcal antigen from throat swab specimens. The test is for professional use.
    Device Description
    Not Found
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    K Number
    K020438
    Device Name
    SAS VALUE HCG
    Manufacturer
    SA SCIENTIFIC, INC.
    Date Cleared
    2002-03-08

    (25 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    SA SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SASTM Value hCG is a visual test for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine.to aid in the early detection of pregnancy. The test is for professional use.
    Device Description
    Not Found
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    K Number
    K013379
    Device Name
    SAS STREPALERT
    Manufacturer
    SA SCIENTIFIC, INC.
    Date Cleared
    2001-12-12

    (61 days)

    Product Code
    GTY
    Regulation Number
    866.3740
    Why did this record match?
    Applicant Name (Manufacturer) :

    SA SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SASTM StrepAlert is a visual test for the qualitative detection of Group A Streptococcus antigen in throat swab specimens. The test is for professional use.
    Device Description
    Not Found
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