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510(k) Data Aggregation
K Number
K080916Device Name
CAPILLARYS URINE
Manufacturer
SEBIA
Date Cleared
2008-07-01
(90 days)
Product Code
JKM
Regulation Number
866.5150Why did this record match?
Product Code :
JKM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CAPILLARYS URINE kit is designed for the preparation of urine samples before separation of human urine proteins in alkaline buffer (pH 9.9) with the CAPILLARYS system. The CAPILLARYS performs automatically all sequences to obtain a urinary protein profile for qualitative analysis. The proteins, separated in silica capillaries, are directly detected at an absorbance of 200 nm. The electrophoretograms can be interpreted visually to detect for any pattern abnormalities (monoclonal components, particularly Bence Jones proteins and other urinary proteins). The test results should be used in conjunction with clinical and laboratory findings.
Device Description
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K Number
K070486Device Name
CAPILLARYS URINE (PN 2012)
Manufacturer
Sebia, Inc.
Date Cleared
2007-12-21
(304 days)
Product Code
JKM
Regulation Number
866.5150Why did this record match?
Product Code :
JKM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K050119Device Name
PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT
Manufacturer
BECKMAN COULTER, INC.
Date Cleared
2005-05-06
(108 days)
Product Code
JKM, CFF, DEH, DFH
Regulation Number
866.5150Why did this record match?
Product Code :
JKM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PARAGON CZE® 2000 Urine Protein Electrophoresis (UPE) Kit is intended for use with the Paragon CZE 2000 Capillary Electrophoresis System for the electrophoretic separation of proteins in human urine.
The PARAGON CZE® 2000 Urine Immunofixation by Subtraction (U-IFE/s) Electrophoresis Kit is intended for use with the Paragon CZE 2000 Capillary Electrophoresis System for the immunologic identification of monoclonal components in human urine.
Device Description
The PARAGON CZE® 2000 UPE and U-IFE/s kits are designed for optimal performance on the PARAGON CZE® 2000. The UPE kits contain one Segment package containing 20 Segments, five Desalting Column packages with 4 columns per package, and four 500 mL Desalting Reagent bottles. The U-IFE/s kits contain two Segment packages containing 10 Segments, one Desalting Column package with 4 columns per package, and one 500 mL Desalting Reagent bottle.
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K Number
K972591Device Name
HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT
Manufacturer
MORAX
Date Cleared
1998-03-04
(236 days)
Product Code
JKM
Regulation Number
866.5150Why did this record match?
Product Code :
JKM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HYDRAGEL BENCE JONES, MAXI KIT HYDRAGEL BENCE JONES, HYDRAGEL 2 BENCE JONES and HYDRAGEL 4 BENCE JONES kits are designed for qualitative detection and identification of Bence Jones proteins (monoclonal free light chains) in urine and serum. The detection of Bence Jones proteins serves as a qualitative aid in the identification of monoclonal gammopathies.
Device Description
The analysis is generally performed on unconcentrated urine or on diluted serum. All these kits utilize the same composition of alkaline buffered HYDRAGEL BENCE JONES agarose gels and the same procedure which is carried out in two stages:
· electrophoresis of the sample on multi-track agarose gel to separate the individual urinary or serum proteins.
· the separated proteins in the reference track are fixed, the remaining tracks are subjected to respective immunofixation with anti aloha, gamma & mu heavy chain trivalent anti kappa and anti lambda free & bound light chains antisera; anti kappa and anti lambda free light chains antisera. The fixed and immunoprecipitated proteins are then stained with acid violet. The electrophoregrams are evaluated visually. The suspect band (in the reference track) is identified from the positive reaction, or lack of, with the individual antisera.
The HYDRAGEL BENCE JONES kit and MAXI KIT HYDRAGEL BENCE JONES are designed for use with a manual electrophoresis apparatus. The only difference between these two kits is the total number of tests which can be performed with i.e., 10 and 100, respectively. Each agarose gel in the HYDRAGEL BENCE JONES kit and MAXI-KIT HYDRAGEL BENCE JONES is intended to run one sample.
The HYDRAGEL 2 BENCE JONES and HYDRAGEL 4 BENCE JONES kits are designed for use with the semi-automated Hydrasys electrophoresis apparatus.
Each agarose gel in the HYDRAGEL 2 BENCE JONES and HYDRAGEL 4 BENCE JONES kits is intended to run two and four samples, respectively.
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