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510(k) Data Aggregation
K Number
K093908Device Name
CCPOINT
Manufacturer
EURO-DIAGNOSTICA AB
Date Cleared
2010-12-01
(344 days)
Product Code
NHX
Regulation Number
866.5775Why did this record match?
Applicant Name (Manufacturer) :
EURO-DIAGNOSTICA AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Euro-Diagnostica CCPoint® test is a visually read, qualitative rapid lateral flow test for the detection of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human serum or plasma. The results of the test are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. For use by trained laboratory professionals. For in vitro diagnostic use.
Device Description
The Euro-Diagnostica CCPoint® test is a visually read, qualitative rapid lateral flow test for the detection of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human serum or plasma. The results of the test are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. For use by trained laboratory professionals. For in vitro diagnostic use.
The CCPoint® test is a colloidal gold based lateral flow immunoassay. Reactive cyclic citrullinated peptides are immobilised as a discrete line on a porous membrane located in the test zone.
The detection reagent, consisting of colloidal gold particles conjugated to anti-human IgG, is deposited within the device onto the conjugate pad.
In the assay procedure, a sample of serum or plasma is added to the sample port. A blood cell separation membrane transfers the sample fluid onto the porous membrane. After a short incubation running buffer is added to the buffer port. This buffer mobilizes the colloidal gold particles from the conjugate pad. The gold particles and the sample move by capillary force across the membrane.
If the sample contains anti-CCP antibodies they will bind to the peptide-antigens and a red line will appear in the test zone (marked T). If the sample does not contain any anti-CCP antibodies no line will appear. With any sample a red control line should appear in the control zone (marked C). The control ensures that the coated colloidal gold is still active.
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K Number
K091657Device Name
IMMUNOSCAN CCPLUS
Manufacturer
EURO-DIAGNOSTICA AB
Date Cleared
2009-11-19
(163 days)
Product Code
NHX
Regulation Number
866.5775Why did this record match?
Applicant Name (Manufacturer) :
EURO-DIAGNOSTICA AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Immunoscan CCPlus® test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semi-quantitative determination 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. "For in vitro diagnostic use".
Device Description
The Immunoscan CCPlus® test kit is a modification of the Immunoscan RA anti-CCP Test kit, K052133. It is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semi-quantitative determination 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. "For in vitro diagnostic use".
The wells are coated with Cyclic Citrullinated Peptides. 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 labelled 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 colour 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
K062045Device Name
EDIA ANTI-CCP
Manufacturer
EURO-DIAGNOSTICA AB
Date Cleared
2006-12-04
(138 days)
Product Code
NHX
Regulation Number
866.5775Why did this record match?
Applicant Name (Manufacturer) :
EURO-DIAGNOSTICA AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EDIA™ 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 and plasma. The assay is used to detect antibodies in a single 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 EDIA™ 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 and plasma. The assay is used to detect antibodies in a single 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. Trained laboratory professionals should perform the analysis. "For in vitro diagnostic use".
The wells are coated with Cyclic Citrullinated Peptides. 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 labelled 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 colour 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
K971464Device Name
IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT
Manufacturer
EURO-DIAGNOSTICA AB
Date Cleared
1997-10-29
(190 days)
Product Code
DBL
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
EURO-DIAGNOSTICA AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Euro-Diagnostica Immunoscan Anti-GBM Kit is an enzyme immunoassay (EIA) kit for the in vitro diagnostic detection of anti-Glomerular Basement Membrane (GBM) antibodies in human serum. This kit is useful as an aid in the diagnosis of autoimmune renal disorders such as Goodpasture's syndrome.
Device Description
enzyme immunoassay (EIA) kit
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K Number
K971689Device Name
IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT
Manufacturer
EURO-DIAGNOSTICA AB
Date Cleared
1997-10-29
(175 days)
Product Code
MOB
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
EURO-DIAGNOSTICA AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Euro-Diagnostica Immunoscan MPO-ANCA Kit is an enzyme immunoassay (EIA) kit for the in vitro detection in human serum of the subclass of Anti-Neutrophil Cytoplasmic Antibodies (ANCA) directed against myeloperoxidase to be used as an aid in the diagnosis of crescentic glomerulonephritis.
Device Description
Not Found
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K Number
K971690Device Name
IMMUNOSCAN PR3-ANCA
Manufacturer
EURO-DIAGNOSTICA AB
Date Cleared
1997-10-29
(175 days)
Product Code
MOB
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
EURO-DIAGNOSTICA AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Euro-Diagnostica Immunoscan PR3-ANCA Kit is an enzyme immunoassay (EIA) kit for the in vitro detection in human serum of the subclass of Anti-Neutrophil Cytoplasmic Antibodies (ANCA) directed against proteinase-3 to be used as an aid in the diagnosis of Wegener's granulomatosis.
Device Description
Not Found
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