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510(k) Data Aggregation
K Number
K100227Device 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
866.3328Why 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
K080380Device Name
SAS INFLUENZA A & B TEST
Manufacturer
SA SCIENTIFIC, INC.
Date Cleared
2009-07-23
(526 days)
Product Code
PSZ, GNX
Regulation Number
866.3328Why 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
K041439Device Name
SAS INFLUENZA B TEST
Manufacturer
SA SCIENTIFIC, INC.
Date Cleared
2004-07-22
(51 days)
Product Code
PSZ, GNX
Regulation Number
866.3328Why 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
K041441Device Name
SAS INFLUENZA A TEST
Manufacturer
SA SCIENTIFIC, INC.
Date Cleared
2004-07-22
(51 days)
Product Code
PSZ, GNX
Regulation Number
866.3328Why 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
K030628Device Name
SAS RSV CONTROL KIT
Manufacturer
SA SCIENTIFIC, INC.
Date Cleared
2003-03-17
(18 days)
Product Code
JJX
Regulation Number
862.1660Why 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
K022845Device Name
SAS RSV TEST
Manufacturer
SA SCIENTIFIC, INC.
Date Cleared
2003-01-29
(155 days)
Product Code
GQG
Regulation Number
866.3480Why 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
K022683Device Name
SAS BLOOD/SERUM/URINE/URINE HCG
Manufacturer
SA SCIENTIFIC, INC.
Date Cleared
2002-12-16
(126 days)
Product Code
JHI
Regulation Number
862.1155Why 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
K023270Device Name
SAS STREPALERT
Manufacturer
SA SCIENTIFIC, INC.
Date Cleared
2002-10-17
(16 days)
Product Code
GTY
Regulation Number
866.3740Why 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
K020438Device Name
SAS VALUE HCG
Manufacturer
SA SCIENTIFIC, INC.
Date Cleared
2002-03-08
(25 days)
Product Code
JHI
Regulation Number
862.1155Why 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
K013379Device Name
SAS STREPALERT
Manufacturer
SA SCIENTIFIC, INC.
Date Cleared
2001-12-12
(61 days)
Product Code
GTY
Regulation Number
866.3740Why 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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