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510(k) Data Aggregation
K Number
K091741Device Name
TINA-QUANT CERULOPLASMIN
Manufacturer
Roche Diagnostics
Date Cleared
2010-03-18
(275 days)
Product Code
CHN
Regulation Number
866.5210Why did this record match?
Product Code :
CHN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Immunoturbidimetric assay for the quantitative in vitro determination of ceruloplasmin in human serum and plasma on Roche automated clinical chemistry analyzers. Measurements obtained by this device aid in the diagnosis of copper metabolism disorders.
Device Description
The Tina-quant Ceruloplasmin assay employs an immunoturbidimetric test in which anti-ceruloplasmin antibodies react with antigen in the sample to form antigen/antibody complexes which, following agglutination can be determined turbidimetrically.
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K Number
K063655Device Name
DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH
Manufacturer
DADE BEHRING, INC.
Date Cleared
2007-02-15
(69 days)
Product Code
CHN, JIX, JJY
Regulation Number
866.5210Why did this record match?
Product Code :
CHN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dimension Vista™ CER Flex® reagent cartridge: The CER method is an in vitro diagnostic test for the quantitative determination of Ceruloplasmin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista System. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.
Dimension Vista™ Protein 1 Calibrator: PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin (PREALB) methods on the Dimension Vista® System.
Dimension Vista" Protein 1 Control L, M and H: PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), ceruloplasmin (CER), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) on the Dimension Vista® System.
Device Description
Dimension Vista™ CER Flex® reagent cartridge: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
Dimension Vista™ Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid, human serum based product containing C3 complement, C4 complement, ceruloplasmin (CER), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).
Dimension Vista™ Protein 1 Control L, M and H: Protein 1 Control L, M and H are multi-analyte, liquid, human serum based products containing C3 complement, C4 complement, ceruloplasmin (CER), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).
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K Number
K062114Device Name
CERULOPLASMIN, MODEL 2055953
Manufacturer
ROCHE DIAGNOSTICS CORP.
Date Cleared
2007-01-31
(191 days)
Product Code
CHN
Regulation Number
866.5210Why did this record match?
Product Code :
CHN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
COBAS INTEGRA Ceruloplasmin: Ceruloplasmin
Indications For Use:
COBAS INTEGRA:
In vitro test for the quantitative immunological determination of ceruloplasmin in human serum and plasma on COBAS INTEGRA systems.
Measurements of Ceruloplasmin aid in the diagnosis of copper metabolism disorders.
Roche/Hitachi cobas c systems:
In vitro test for the quantitative determination of ceruloplasmin in human serum and plasma on Roche/Hitachi cobas c systems.
Measurements of Ceruloplasmin aid in the diagnosis of copper metabolism disorders.
Device Description
The COBAS INTEGRA Ceruloplasmin cassette (CERU) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA SYSTEMS for the quantitative immunological determination of human ceruloplasmin in serum and plasma. The calibrator and control were cleared via K954992.
Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.
The test principle is an immunoturbidimetric assay. The calibrator is Serumproteins T Standard and the recommended control material is the Serumproteins T Control.
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