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510(k) Data Aggregation
K Number
K031563Device Name
BINDAZYME CLQ CIC EIA KIT
Manufacturer
THE BINDING SITE, LTD.
Date Cleared
2003-09-10
(114 days)
Product Code
DAK
Regulation Number
866.5240Why did this record match?
Product Code :
DAK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This assay is designed for the in-vitro measurement of circulating immune complexes (CIC) that bind Clq, measurement on on serum. It is intended for the determination of presence in names patients with various autoimmune and other CICrelated disease, and is used in conjunction with other clinical findings.
Device Description
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K Number
K032254Device Name
IBL C1Q-CIC CIA TEST
Manufacturer
IBL GMBH
Date Cleared
2003-08-29
(38 days)
Product Code
DAK
Regulation Number
866.5240Why did this record match?
Product Code :
DAK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IBL C1q-CIC test is a quantitative enzyme immunoassay for the in vitro diagnostic detection of circulating immune complex that bind C1q in human serum. The measurement is performed as an aid in the diagnosis of various autoimmune and other CIC related diseases. Levels of these complexes are one indicator in a multi-factorial diagnostic regime.
Device Description
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K Number
K012576Device Name
CIC-C1Q EIA
Manufacturer
AMERICAN LABORATORY PRODUCTS CO., LTD.
Date Cleared
2002-01-29
(173 days)
Product Code
DAK
Regulation Number
866.5240Why did this record match?
Product Code :
DAK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CIC-C1q EIA is intended for the quantitative determination of circulating immune complexes (CIC) in serum or plasma.
Device Description
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K Number
K973203Device Name
THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES
Manufacturer
SANGSTAT MEDICAL CORP.
Date Cleared
1998-09-30
(400 days)
Product Code
DAK
Regulation Number
866.5240Why did this record match?
Product Code :
DAK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ThymoStat™ is a qualitative plate ELISA for the detection of human anti-rabbit antibodies in human serum. The presence of human anti-rabbit antibodies has been associated with patients receiving injections of rabbit antibodies for therapeutic purposes.
Device Description
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K Number
K972873Device Name
IMMUSTRIP HAMA IGG
Manufacturer
IMMUNOMEDICS, INC.
Date Cleared
1998-03-17
(225 days)
Product Code
DAK
Regulation Number
866.5240Why did this record match?
Product Code :
DAK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ImmuSTRIP® HAMA IgG ELISA Test System is a direct enzyme-linked immunosorbent assay for the detection and semi-quantitation of human antibodies to mouse IgG1. Significant titers of human anti-mouse antibody (HAMA) have been associated with patients receiving injections of murine monoclonal antibody for diagnostic and/or therapeutic purposes2 .
Device Description
The ImmuSTRIP" HAMA IgG ELISA Test System is a direct enzyme linked immunosorbent assay for the semi-quantitative detection of human antibodies to mouse IgG (HAMA).
The HAMA assay is a two-stage test carried out in plastic microwell strips which have been coated with mouse IgG, whole molecule.
In the first stage, mouse IgG conjugated to horseradish peroxidase (conjugate) is added to the microwell. Diluted test sample is then added and incubated for a specified length of time. If antibody to the mouse IgG is present in the test sample, bridging will occur with the solid phase mouse IgG, the test sample antibody, and the conjugate. If antibody is not present in the test sample, the unbound conjugate will be removed in the subsequent washing step.
In the second stage, enzyme substrate is added to the microwell. If bound conjugate is present, the substrate will be reduced; the reduced end product of the catalytic reaction oxidizes the colorless chromogen resulting in a colored end product. Acid is added to stop the reaction and fix the color.
The color intensity is proportional to the amount of bound conjugate and, therefore, to the amount of precipitable antibody present in the sample. The color intensity is measured with a microwell strip reader.
The ImmuSTRIP" HAMA ELISA Test System may be performed manually or with existing microtiter equipment. Results, which are determined by optical density at 488-492 nm, are available in less than one hour. The test has been standardized against primate anti-mouse IgG serum and has a sensitivity of approximately 40 ng/ml. Final values are reported as nanograms of precipitable antibody equivalents per ml.
The assay system is a rapid, efficient, and semi-quantitative method. Specific reagent formulation has eliminated the problem of background interference currently existing in this type of assay.
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