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510(k) Data Aggregation
K Number
K981748Device Name
WIELISA ANCA SCREENING KIT TEST SYSTEM
Manufacturer
WIESLAB AB
Date Cleared
1998-07-22
(65 days)
Product Code
MOB
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
WIESLAB AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wielisa ANCA Screening Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of antibodies to Proteinase-3 (PR-3) and Myeloperoxidase (MPO) in human sera. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of systemic vasculitis, especially Wegener's granulomatosis (WG) and microcopic polyangiitis (MP). The assay is intended for use in patients with signs and symptoms consistent with systemic vasculitis. It is not intended for screening a healthy population. A positive result should always be confirmed by a semi-quantitative assay.
Device Description
The Wielisa ANCA Screening Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of antibodies to Proteinase-3 (PR-3) and Myeloperoxidase (MPO) in human sera. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of systemic vasculitis, especially Wegener's granulomatosis (WG) and microcopic polyangiitis (MP). The assay is intended for use in patients with signs and symptoms consistent with systemic vasculitis. It is not intended for screening a healthy population. A positive result should always be confirmed by a semi-quantitative assay.
The wells of the microtiter strips are coated with purified (Human Neutrophil source) proteinase 3, and MPO (Human Neutrophil source) antigen. During the first incubation, specific antibodies in diluted serum, will bind to the antigen coating.
The wells are then washed to remove unbound antibodies and other components. A conjugate of alkaline phosphatase-labeled (Goat) antibodies to human IgG binds to the antibodies in the wells in this second incubation.
After a further washing step, detection of specific antibodies is obtained by incubation with substrate solution. The amount of bound antibodies correlates to the color intensity and is measured in terms of absorbance (optical density (OD)). The absorbance is then calculated and the results are given as a ratio to the negative control.
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K Number
K981750Device Name
WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM
Manufacturer
WIESLAB AB
Date Cleared
1998-07-22
(65 days)
Product Code
MOB, DBL
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
WIESLAB AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wielisa Anti-GBM, ANCA Screening Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of antibodies to glomerular basement membrane (GBM), Proteinase-3 (PR-3) and Myeloperoxidase (MPO) in human sera. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of reno-pulmonary syndromes and rapidly progressive glomerulonephritis, especially Goodpasture syndrome (GP), Wegener's granulomatosis (WG) and microcopic polyangiitis (MP). The assay is intended for use in patients with signs and symptoms consistent with GP, WG, and MP. It is not intended for screening a healthy population. A positive result should always be confirmed by a semi-quantitative assay.
Device Description
The Wielisa Anti-GBM, ANCA Screening Test Kit is an II. enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of antibodies to glomerular basement membrane (GBM), Proteinase-3 (PR-3) and Myeloperoxidase (MPO) in human sera. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of reno-pulmonary syndromes and rapidly progressive glomerulonephritis, especially Goodpasture syndrome (GP). Wegener's granulomatosis (WG) and microcopic polyangiitis (MP). The assay is intended for use in patients with signs and symptoms consistent with GP, WG, and MP. It is not intended for screening a healthy population. A positive result should always be confirmed by a semi-quantitative assay.
The wells of the microtiter strips are coated with purified proteinase 3 (Human Neutrophil source). MPO (Human Neutrophil source) and GBM (Bovine source) antigen. During the first incubation, specific antibodies in diluted serum, will bind to the antigen coating.
The wells are then washed to remove unbound antibodies and other components. A coniugate of alkaline phosphatase-labeled (Goat) antibodies to human IgG binds to the antibodies in the wells in this second incubation.
After a further washing step, detection of specific antibodies is obtained by incubation with substrate solution. The amount of bound antibodies correlates to the color intensity and is measured in terms of absorbance (optical density (OD)). The absorbance is then calculated and the results are given as a ratio to the negative control.
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K Number
K974166Device Name
WIELISA MPO ANCA TEST SYSTEM
Manufacturer
WIESLAB AB
Date Cleared
1998-02-17
(104 days)
Product Code
MOB
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
WIESLAB AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Wielisa MPO ANCA Test Kit. An Enzyme Linked Immunosorbent Assay (ELISA) for the detection and semi-quantitation of IgG antibodies in human serum to MPO (Myeloperoxidase). The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of Microscopic polyangiitis.
Device Description
The Wielisa MPO ANCA Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG antibodies to myeloperoxidase (MPO) in human sera. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of microscopic polyangiitis. FOR IN VITRO DIAGNOSTIC USE.
The wells of the microtiter strips are coated with purified myeloperoxidase. During the first incubation, specific antibodies in diluted serum, will bind to the antigen coating.
The wells are then washed to remove unbound antibodies and other components. A conjugate of alkaline phosphatase-labeled antibodies to human IgG binds to the antibodies in the wells in this second incubation.
After a further washing step. detection of specific antibodies is obtained by incubation with substrate solution. The amount of bound antibodies correlates to the color intensity and is measured in terms of absorbance (optical density (OD)). The absorbance is then calculated against a calibrator curve and the results are given in arbitrary units.
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K Number
K974167Device Name
WIELISA PR-3 ANCA TEST SYSTEM
Manufacturer
WIESLAB AB
Date Cleared
1998-02-17
(104 days)
Product Code
MOB
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
WIESLAB AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wielisa PR-3 ANCA Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of antibodies to Proteinase-3 (PR-3) in human sera. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of Wegener's granulomatosis.
Device Description
The Wielisa PR-3 ANCA Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of lgG antibodies to Proteinase-3 (PR-3) in human sera. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of Wegener's granulomatosis. FOR IN VITRO DIAGNOSTIC USE.
The wells of the microtiter strips are coated with purified proteinase 3. During the first incubation, specific antibodies in diluted serum, will bind to the antigen coating,
The wells are then washed to remove unbound antibodies and other components. A conjugate of alkaline phosphatase-labeled antibodies to human IgG binds to the antibodies in the wells in this second incubation.
After a further washing step, detection of specific antibodies is obtained by incubation with substrate solution. The amount of bound antibodies correlates to the color intensity and is measured in terms of absorbance (optical density (OD)). The absorbance is then calculated against a calibrator curve and the results are given in arbitrary units.
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K Number
K974169Device Name
WIELISA ANTI-GBM TEST SYSTEM
Manufacturer
WIESLAB AB
Date Cleared
1998-02-17
(104 days)
Product Code
DBL
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
WIESLAB AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wielisa anti-GBM Test Kit is an Enzyme Linked Immunosorbent Assay (ELISA) for the detection and semi-quantitation of IgG antibodies in human serum to GBM (glomerular basement membrane). The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of Goodpasture syndrome. FOR IN VITRO DIAGNOSTIC USE.
Device Description
The Wielisa anti-GBM Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG antibodies to glomerular basement membrane(GBM) in human sera. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of Goodpasture syndrome. FOR IN VITRO DIAGNOSTIC USE. The wells of the microtiter strips are coated with purified GBM antigen. During the first incubation, specific antibodies in diluted serum, will bind to the antigen coating. The wells are then washed to remove unbound antibodies and other components. A conjugate of alkaline phosphatase-labeled antibodies to human IgG binds to the antibodies in the wells in this second incubation. After a further washing step, detection of specific antibodies is obtained by incubation with substrate solution. The amount of bound antibodies correlates to the color intensity and is measured in terms of absorbance (optical density (OD)). The absorbance is then calculated against a calibrator curve and the results are given in arbitrary units.
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