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Found 8 results
510(k) Data Aggregation
K Number
K071711Device Name
ASCA-CHEK
Manufacturer
TECHLAB INC., CORPORATE RESEARCH CENTER
Date Cleared
2007-11-07
(138 days)
Product Code
NBT
Regulation Number
866.5785Why did this record match?
Product Code :
NBT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ASCA-CHEK test is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of human anti-S. cerevisiae antibodies (ASCA) in feces and serum. The test result is used as an aid in the diagnosis of Crohn's disease in combination with clinical and other laboratory findings. FOR IN VITRO DIAGNOSTIC USE.
Device Description
The ASCA-CHEK test is an ELISA for the measurement of human anti-S. cerevisiae antibodies in feces and serum as an indicator of Crohn's disease in combination with other clinical and laboratory findings. The assay utilizes antigens of S. cerevisiae for capture and a polyvalent anti-human immunoglobulin conjugate. For feces, a specimen dilution of 1:10 and an OD 450 cut-off ≥0.150 or OD450620 ≥0.110 are used for the analysis. For serum, a specimen dilution of 1:1000 and an OD450 cut-off ≥0.110 or OD450620 ≥0.080 are used for the analysis. When human ASCA is present in fecal or serum specimens, the specific immunoglobulins bind to the S. cerevisiae antigens that are immobilized in the test well. Following this binding step, the polyvalent anti-human horseradish peroxidase (HRP) conjugate binds to the ASCA and reacts with the substrate to produce a positive result. The measurement of fecal and serum ASCA is an indicator of Crohn's disease within the setting of differentiating Crohn's disease from ulcerative colitis and IBS. This diagnostic method offers a simple to perform assay that may be used with either fecal or serum specimens.
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K Number
K051927Device Name
TECHLAB ASCA-CHEK
Manufacturer
TECHLAB, INC.
Date Cleared
2006-04-06
(262 days)
Product Code
NBT
Regulation Number
866.5785Why did this record match?
Product Code :
NBT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TECHLAB® ASCA-CHEK test is an ELISA for the qualitative detection of human anti-S. cerevisiae antibodies (ASCA) in feces. The test result is used as an aid in the diagnosis of Crohn's disease in combination with clinical and other laboratory findings. FOR IN VITRO DIAGNOSTIC USE.
Device Description
The TECHLAB® ASCA-CHEK test is an enzyme-linked immunoassay (ELISA) for the measurement of human anti-S. cerevisiae antibodies in feces as an aid in the diagnosis of Crohn's disease. The assay utilizes antigens of S. cerevisiae for capture and a polyvalent anti-human immunoglobulin conjugate. When human ASCA is present in the fecal specimen, the specific immunoglobulins bind to the S. cerevisiae antigens that are immobilized in the test well. Following this binding step, the polyvalent anti-human horseradish peroxidase (HRP) conjugate binds to the ASCA and reacts with the substrate to produce a positive result. The measurement of fecal ASCA is an aid in the diagnosis of Crohn's disease within the setting of differentiating Crohn's disease from ulcerative colitis. This noninvasive diagnostic method is simple to perform and requires only a fecal specimen for the analysis.
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K Number
K051492Device Name
AESKULISA ASCA A
Manufacturer
AESKU.INC
Date Cleared
2005-11-14
(161 days)
Product Code
NBT
Regulation Number
866.5785Why did this record match?
Product Code :
NBT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AESKULISA ASCA-A is a solid phase enzyme immunoassay (ELISA) employing purified mannan for the semi-quantitative and qualitative detection of IgA anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum. ASCA recognize specifically mannan, a component of the outer cell wall of yeast. The AESKULISA ASCA A kit should not be used as a screening test for ASCA, since some Crohn's disease patients do not have ASCA IgA antibodies. The AESKULISA ASCA A kit should be used to compliment, but not to replace or to substitute for ASCA IgG antibody testing. The assay is an aid in the diagnosis of Crohn's disease and should be used in conjunction with other serological tests and clinical findings.
AESKULISA ASCA-G is a solid phase enzyme immunoassay (ELISA) employing purified mannan for the semi-quantitative and qualitative detection of IgG anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum. ASCA recognize specific mannan, a component of the outer cell wall of yeast. The assay is an aid in the diagnosis of Crohn`s disease and should be used in conjunction with other serological tests and clinical findings.
Device Description
solid phase enzyme immunoassay (ELISA) employing purified mannan
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K Number
K042579Device Name
BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT
Manufacturer
THE BINDING SITE
Date Cleared
2005-07-28
(309 days)
Product Code
NBT
Regulation Number
866.5785Why did this record match?
Product Code :
NBT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This assay is intended for the in vitro semi-quantitative measurement of ASCA IgA anti-Saccharomyces cerevisiae antibody in human serum. The presence of ASCA may aid in the diagnosis of patients with Crohn's disease. The test results should be used in conjunction with clinical findings and other laboratory tests. The ASCA IgA should not be used alone as a screening test for ASCA. ASCA IgA test should be used to complement, but not to replace or to substitute the ASCA IgG antibody test since some Crohn's disease subgroup patients may not have IgA antibodies.
Device Description
Not Found
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K Number
K032850Device Name
IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG)
Manufacturer
IMMCO DIAGNOSTICS, INC.
Date Cleared
2004-03-18
(188 days)
Product Code
NBT
Regulation Number
866.5785Why did this record match?
Product Code :
NBT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An enzyme linked immunosorbent assay (ELISA) for the detection and semiquantitation of anti-Saccharomyces cerevisiae IgG antibodies in human serum of patients with inflammatory bowel disorder (IBD) as an aid in the diagnosis of Crohn's disease (CD).
Device Description
An enzyme linked immunosorbent assay (ELISA) for the detection and semiquantitation of anti-Saccharomyces cerevisiae IgG antibodies in human serum of patients with inflammatory bowel disorder (IBD) as an aid in the diagnosis of Crohn's disease (CD).
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K Number
K032860Device Name
IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)
Manufacturer
IMMCO DIAGNOSTICS, INC.
Date Cleared
2004-03-18
(188 days)
Product Code
NBT
Regulation Number
866.5785Why did this record match?
Product Code :
NBT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An enzyme linked immunosorbent assay (ELISA) for the detection and semiquantitation of anti-Saccharomyces cerevisiae IgA antibodies in human serum of patients with inflammatory bowel disorder (IBD) as an aid in the diagnosis of Crohn's disease (CD).
Device Description
An enzyme linked immunosorbent assay (ELISA) for the detection and semiquantitation of anti-Saccharomyces cerevisiae IgA antibodies in human serum.
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K Number
K000733Device Name
QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA
Manufacturer
INOVA DIAGNOSTICS, INC.
Date Cleared
2001-05-21
(441 days)
Product Code
NBT
Regulation Number
866.5785Why did this record match?
Product Code :
NBT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
DEN000007Device Name
QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA
Manufacturer
INOVA DIAGNOSTICS, INC.
Date Cleared
2000-08-16
(29 days)
Product Code
NBT
Regulation Number
866.5785Why did this record match?
Product Code :
NBT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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