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510(k) Data Aggregation
K Number
K093678Device Name
PLATELIA ASPERGILLUS EIA MODEL 62793
Manufacturer
BIO-RAD
Date Cleared
2011-01-13
(412 days)
Product Code
NOM, DAT
Regulation Number
866.3040Why did this record match?
Product Code :
NOM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Platelia™ Aspergillus EIA is an immunoenzymatic sandwich microplate assay for the detection of Aspergillus galactomannan antigen in adult and pediatric serum and Bronchoalveolar Lavage (BAL) fluid samples.
The Platelia™ Aspergillus EIA is a test which, when used in conjunction with other diagnostic procedures such as microbiological culture, histological examination of biopsy samples and radiographic evidence, can be used as an aid in the diagnosis of Invasive Aspergillosis.
Device Description
The Platelia™ Aspergillus EIA is a one-stage immunoenzymatic sandwich microplate assay which detects galactomannan in human serum and BAL fluid samples. The assay uses rat EBA-2 monoclonal antibodies, which are directed against Aspergillus galactomannan, and have been characterized in previous studies. The monoclonal antibodies are used, (1) to coat the wells of the microplate and bind the antigen, and (2) to detect the antigen bound to the sensitized microplate reagent: peroxidase-linked monoclonal antibodies).
Serum or BAL fluid samples are heat-treated in the presence of EDTA in order to dissociate immune complexes and to precipitate proteins that could possibly interfere with the test. The treated samples and conjugate are added to the wells coated with monoclonal antibodies, and incubated. A monoclonal antibody - galactomannan monoclonal antibody / peroxidase complex is formed in the presence of galactomannan antigen.
The strips are washed to remove any unbound material. Next, the substrate solution is added, which will react with the complexes bound to the well to form a blue color reaction. The enzyme reaction is stopped by the addition of acid, which changes the blue color to yellow. The absorbance (optical density) of specimens and controls is determined with a spectrophotometer set at 450 and 620/630 nm wavelength.
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K Number
K060641Device Name
PLATELIA ASPERGILLUS EIA, MODEL 62793
Manufacturer
BIO-RAD
Date Cleared
2006-06-02
(84 days)
Product Code
NOM
Regulation Number
866.3040Why did this record match?
Product Code :
NOM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Platelia™ Aspergillus EIA is an immunoenzymatic sandwich microplate assay for the detection of Aspergillus galactomannan antigen in adult and pediatric serum samples.
The Platelia™ Aspergillus EIA is a test which, when used in conjunction with other diagnostic procedures such as microbiological culture, histological examination of biopsy samples and radiographic evidence, can be used as an aid in the diagnosis of Invasive Aspergillosis.
Device Description
The Platelia™ Aspergillus EIA is a one-stage immunoenzymatic sandwich microplate assay which detects galactomannan in human serum. The assay uses rat EBA-2 monoclonal antibodies, which are directed against Aspergillus galactomannan, and have been characterized in previous studies 19,16. The monoclonal antibodies are used to coat the wells of the microplate and bind the antigen, and to detect the antigen bound to the sensitized microplate (conjugate reagent: peroxidase-linked monoclonal antibodies).
Serum samples are heat-treated in the presence of EDTA in order to dissociate immune complexes and to precipitate serum proteins that could possibly interfere with the test . The treated serum samples and conjugate are added to the wells coated with monoclonal antibodies, and incubated. A monoclonal antibody - galactomannan - monoclonal antibody / peroxidase complex is formed in the presence of galactomannan antigen. The strips are washed to remove any unbound material. Next, the substrate solution is added, which will react with the complexes bound to the well to form a blue color reaction. The enzyme reaction is stopped by the addition of acid, which changes the blue color to yellow. The absorbance (optical density) of specimens and controls is determined with a spectrophotometer set at 450 and 620/630 nm wavelength.
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K Number
K023857Device Name
PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794
Manufacturer
BIO-RAD
Date Cleared
2003-05-16
(177 days)
Product Code
NOM
Regulation Number
866.3040Why did this record match?
Product Code :
NOM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Platelia® Aspergillus EIA is an immunoenzymatic sandwich microplate assay for the detection of Aspergillus galactomannan antigen in serum.
The Platelia® Aspergillus EIA is a test which, when used in conjunction with other diagnostic procedures such as microbiological culture, histological examination of biopsy samples and radiographic evidence, can be used as an aid in the diagnosis of invasive aspergillosis.
Device Description
The Platelia Aspergillus EIA is a one-stage immunoenzymatic sandwich microplate assay which detects galactomannan in human serum. The assay uses the rat monoclonal antibody EBA-2, which is directed antibody is used: to coat the wells of the microplate and bind the antigen, and as the detector antibody in the conjugate reagent (peroxidase-linked monoclonal antibody).
Serum samples are heat-treated in the presence of EDTA in order to dissociate immune-complexes and to precipitate serum proteins that could possibly interfere with the test. The treated serum samples and conjugate are added to the wells coated with monoclonal antibody, and incubated. A monoclonal antibody - galactomannan - monoclonal antibody / peroxidase complex is formed in the presence of Aspergillus antigen. The strips are washed to remove any unbound material. Next, the substrate solution is added, which will react with the complexes bound to the well to form a blue color reaction. The enzyme reaction is stopped by the addition of acid, which changes the blue color to yellow. The optical absorbance of specimens and controls is determined with a spectrophotometer set at 450 and 620/630 nm wavelength.
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