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510(k) Data Aggregation
K Number
K052133Device Name
IMMUNOSCAN RA ANTI-CCP TEST SYSTEM
Manufacturer
EURODIAGNOSTICA
Date Cleared
2005-12-12
(129 days)
Product Code
NHX
Regulation Number
866.5775Why did this record match?
Applicant Name (Manufacturer) :
EURODIAGNOSTICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Immunoscan RA anti-CCP test kit is an enzyme-linked immunosorbent assay (ELISA) for detection and semi-quantitation of IgG antibodies to Cyclic Citrullinated Peptides (CCP) 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 Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. The analysis should be performed by trained laboratory professionals.
Device Description
The Immunoscan RA anti-CCP test kit is an enzyme-linked immunosorbent assay (ELISA) for detection and semi-quantitation of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera.
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K Number
K051455Device Name
WIESLAB CAP MPO-ANCA
Manufacturer
EURODIAGNOSTICA
Date Cleared
2005-11-23
(174 days)
Product Code
MOB
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
EURODIAGNOSTICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K051458Device Name
WIESLAB CAP PR-3 ANCA
Manufacturer
EURODIAGNOSTICA
Date Cleared
2005-11-22
(173 days)
Product Code
MOB
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
EURODIAGNOSTICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wieslab™ Cap PR3-ANCA is an enzyme-linked immunosorbent assay (ELISA) for detection and semi-quantitation of IgG antibodies to proteinase 3 (PR3) 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. The assay is intended for use in patients with signs and symptoms consistent with WG. It is not intended for screening a healthy population. The analysis should be performed by trained laboratory professionals.
Device Description
The Capture-PR3-ANCA test kit is an enzyme-linked immunosorbent assay (ELISA) for detection and semi-quantitation of IgG antibodies to proteinase 3 (PR3) 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. The assay is intended for use in patients with signs and symptoms consistent with WG. It is not intended for screening a healthy population. The analysis should be performed by trained laboratory professionals.
The wells of the microtiter strips are coated with monoclonal antibody to proteinase 3 and subsequently 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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