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510(k) Data Aggregation
K Number
K061970Device Name
ELECSYS IGE II IMMUNOASSAY
Manufacturer
Roche Diagnostics
Date Cleared
2006-08-31
(50 days)
Product Code
JHR
Regulation Number
866.5510Why did this record match?
Product Code :
JHR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Immunoassay for the in vitro quantitative determination of immunoglobulin E in human serum and plasma. Determination of total IgE is useful as an aid in the diagnosis of allergic diseases. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.
Device Description
The Elecsys IgE II immunoassay is a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code.
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K Number
K984326Device Name
ELECYS IGE ASSAY
Manufacturer
BOEHRINGER MANNHEIM CORP.
Date Cleared
1999-02-08
(67 days)
Product Code
JHR
Regulation Number
866.5510Why did this record match?
Product Code :
JHR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For in vitro quantitative determination of immunoglobulin E in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers. Determination of total serum IgE is useful as an aid in the diagnosis of allergic disease.
Device Description
The Elecsys® IgE test is based on the sandwich principle of heterogeneous immunological complex formation. First Step: Biotinylated monoclonal antibodies (R1) and ruthenium labeled antibodies (R2), both specific for IgE, bind IgE present in the sample forming a sandwich complex Second Step: Microparticles coated with streptavidin (M) bind the biotin portion of the complex and are captured magnetically onto the surface of the electrode. Application of a voltage to the electrode induces chemiluminescent emission, which is measured by a photomultiplier.
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K Number
K960067Device Name
IMMILITE TOTAL IGE
Manufacturer
DIAGNOSTIC PRODUCTS CORP.
Date Cleared
1996-02-14
(40 days)
Product Code
JHR
Regulation Number
866.5510Why did this record match?
Product Code :
JHR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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