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510(k) Data Aggregation

    K Number
    K153560
    Device Name
    Optilite Low Level Albumin Kit
    Manufacturer
    THE BINDING SITE GROUP LTD
    Date Cleared
    2016-08-25

    (255 days)

    Product Code
    DCF
    Regulation Number
    866.5040
    Why did this record match?
    Product Code :

    DCF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Optilite Low Level Albumin Kit is intended for the quantitative in vitro measurement of albumin in CSF, urine and serum using the Binding Site Optilite analyser to aid in the diagnosis of kidney and intestinal diseases. This test should be used in conjunction with other laboratory and clinical findings.
    Device Description
    The Optilite Low Level Albumin Kit is comprised of the following reagents: Antiserum, Calibrator and Controls, and Reaction Buffer. In Optilite kits, the antiserum reagent and reaction buffer are supplied in a single wedge with a chamber for each fluid. They are therefore labelled as a single component Optilite LLAlb Reagent. The Antigen Excess Control does not have an assigned value.
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    K Number
    K143118
    Device Name
    Human Microalbumin kit for use on SPAPLUS
    Manufacturer
    THE BINDING SITE GROUP LTD
    Date Cleared
    2015-05-26

    (208 days)

    Product Code
    DCF
    Regulation Number
    866.5040
    Why did this record match?
    Product Code :

    DCF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Human Microalbumin kit for use on SPAPLUS kit is intended for the quantitative measurement of human albumin in human urine using the SPAPLUS turbidimetric analyser. Measurement of albumin in human urine is an aid in the diagnosis of renal disease. This test should be used in conjunction with other laboratory and clinical findings. For in vitro diagnostic use only.
    Device Description
    Not Found
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    K Number
    K142346
    Device Name
    Urine/CSF Albumin, Urine/CSF Albumin Calibrator
    Manufacturer
    Beckman Coulter Ireland Inc.
    Date Cleared
    2014-10-15

    (54 days)

    Product Code
    DCF, JIT
    Regulation Number
    866.5040
    Why did this record match?
    Product Code :

    DCF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Urine/CSF Albumin: The Urine/CSF Albumin reagent is intended to be used for the quantitation of albumin concentration in human urine and cerebrospinal fluid (CSF) on the Beckman Coulter AU clinical chemistry systems as an aid in the diagnosis of kidney diseases. For in vitro diagnostic use only. Urine/CSF Albumin Calibrator: The Urine/CSF Albumin calibrator is intended to be used to calibrate the Urine/CSF Albumin reagent on the Beckman Coulter AU clinical chemistry systems. For in vitro diagnostic use only.
    Device Description
    The Urine/CSF Albumin reagent kit is in a liquid, ready to use format. There are two kit concepts available. Each kit concept contains an R1 and an R2 reagent vial with different fill volumes. The Urine/CSF Albumin calibrator kit is in a liquid, ready to use format and contains 5 x 2 mL calibrator levels. It is packaged and sold separately to the reagent kit. Urine/CSF Albumin reagent is used to measure albumin concentration by a turbidimetric method. In the reaction, anti-human serum albumin antibodies combine with albumin from the sample to form immune complexes that scatter light in proportion to their size, shape and concentration. The absorbance of these aggregates is proportional to the albumin concentration in the sample. Change in absorbance is measured at 380nm with subtraction of a reference wavelength at 800nm. The Urine/CSF Albumin reagent and calibrator is designed for optimal performance on Beckman Coulter AU clinical chemistry analyzers.
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    K Number
    K121045
    Device Name
    HUMAN ALBUMIN CSF KIT
    Manufacturer
    THE BINDING SITE GROUP, LTD.
    Date Cleared
    2013-06-19

    (439 days)

    Product Code
    DCF
    Regulation Number
    866.5040
    Why did this record match?
    Product Code :

    DCF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Human Albumin CSF Kit for use on SPAPLUS is intended for the in-vitro quantification of human albumin in serum and cerebrospinal fluid (CSF) samples on the SPAPLUS analyser. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases in conjunction with other laboratory and clinical findings.
    Device Description
    Not Found
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    K Number
    K113072
    Device Name
    TINA-QUANT ALBUMIN GEN.2
    Manufacturer
    ROCHE DIAGNOSTICS OPERATIONS
    Date Cleared
    2012-05-14

    (210 days)

    Product Code
    DCF
    Regulation Number
    866.5040
    Why did this record match?
    Product Code :

    DCF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tina-quant Albumin Gen.2 assay is an immunoturbidimetric assay intended for the quantitative determination of albumin in human urine on Roche/Hitachi cobas c systems. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.
    Device Description
    The Tina-quant Albumin Gen. 2 - cobas c 311 urine assay employs an immunoturbidimetric test in which anti-albumin antibodies react with the antigen in the sample to form antigen/antibody complexes which, following agglutination are determined turbidimetrically.
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    K Number
    K101089
    Device Name
    EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR
    Manufacturer
    MEDICA CORP.
    Date Cleared
    2011-07-13

    (450 days)

    Product Code
    DCF, JIT
    Regulation Number
    866.5040
    Why did this record match?
    Product Code :

    DCF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EasyRA µALB reagent is intended for the quantitative determination of micro-albumin in human urine, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Micro-albumin measurements using immunological tests aid in the diagnosis of kidney diseases. The EasyRA micro-albumin (µALB) calibrator facilitates measurements of µALB on the EasyRA clinical chemistry analyzer when used in conjunction with Medica's µALB reagent. The µALB calibrator is used to establish points of reference that are used in the determination of values in the measurement of µALB in human urine.
    Device Description
    Not Found
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    K Number
    K101203
    Device Name
    TINA-QUANT ALBUMIN GEN 2
    Manufacturer
    Roche Diagnostics
    Date Cleared
    2010-09-10

    (134 days)

    Product Code
    DCF
    Regulation Number
    866.5040
    Why did this record match?
    Product Code :

    DCF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tina-quant Albumin Gen. 2 assay is an immunoturbidimetric assay intended for the quantitative determination of albumin in serum, plasma, urine, and CSF on Roche/Hitachi cobas c systems. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.
    Device Description
    The Tina-quant Albumin Gen. 2 assay employs an immunoturbidimetric test in which anti-albumin antibodies react with the antigen in the sample to form antigen/antibody complexes which, following agglutination are determined turbidimetrically.
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    K Number
    K100853
    Device Name
    COBAS 8000 MODULAR SERIES ANALYZER
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2010-09-09

    (167 days)

    Product Code
    DCF, CDQ, CDT, CEM, CEO, CFJ, CFR, CGX, CGZ, CHH, CHN, CIC, CIG, CIT, CIX, CJE, CJW, CJX, CZP, CZW, DAD, DAO, DBF, DBI, DCN, DDG, DDR, DEM, DER, DFC, DHR, DIH, DIO, DIP, DIS, DJG, DJR, DKJ, DKZ, DLB, DLZ, DML, GHH, JFJ, JGJ, JGQ, JGS, JHS, JIF, JIY, JJE, JMO, JXM, JXN, JZG, KHP, KHS, KLB, KLP, KLS, KNK, KXS, KXT, LAN, LAR, LBS, LBZ, LCM, LCP, LDJ, LDP, LEG, LEH, MRR, NDW, NDY, NQD, OAV
    Regulation Number
    866.5040
    Why did this record match?
    Product Code :

    DCF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The cobas 8000 Modular Analyzer Series is a fully automated system for clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit. It is intended for use in conjunction with certain materials to measure a variety of analytes that may bbe adaptable to the below analyzers depending on the reagents used. The cobas c701 analyzer is a fully automated, discrete clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids. The cobas c502 analyzer is a fully automated discrete clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids. The cobas 8000 ISE module is a fully automated ion- specific analyzer intended for the in vitro potentiometric determination of chloride, potassium and sodium in serum and plasma using ion-selective electrodes. Measurements obtained by this device are used in the diagnosis and treatment of diseases or conditions involving electrolyte imbalance. IGA-2 is an in vitro test for the quantitative determination of IgA in human serum and plasma on Roche/Hitachi cobas c systems. IgA measurements aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
    Device Description
    The cobas 8000 Modular Analyzer Series is a fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (cobas 8000 ISE module) and photometric analysis modules (cobas c 701 and c 502 modules). The cobas c 701 and c 502 analyzer modules are new members of the Roche / Hitachi family of clinical chemistry analyzers. The cobas 8000 ISE module is an Ion-selective electrode system for the determination of sodium, potassium and chloride in serum and plasma. The cobas c 701 module is a fully automated, discreet, computerized instrument for in vitro tests on a wide range of analytes. It is designed to use serum/plasma, urine, CSF supernatant and whole blood sample types. The related sample buffer module offers a random access buffer function for samples. The cobas c 502 module is analytically identical to the cobas c 501 module (cobas 6000 analyzer series. K060373), but without an integrated ISE module. The related sample buffer module offers a random access buffer function for samples. The cobas 8000 Data Manager acts as a command/control center between the cobas 8000 instrument and the LIS. The data manager software is installed on a PC. It also provides enhanced sample tracking, test management, result traceability, storage and reporting, quality control and calibration management, has LIS backup functionality and serves as a robust storage location for the instrument. The control unit uses a graphical user interface to control all instrument functions, and is comprised of a touch screen monitor, keyboard and mouse and a personal computer. The core unit is comprised of several components that manage conveyance of samples to each assigned analytical module. The actual composition of the core unit depends on the configuration of the analytical modules. Features of the Core Unit include a barcode reader (for racks and samples), automatic tube position if barcode position is misaligned, system power switch and circuit breaker, the sample rack loader/unloader, a STAT port, a water supply and a system interface port.
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    K Number
    K091486
    Device Name
    K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    2010-04-29

    (345 days)

    Product Code
    DCF, JIT
    Regulation Number
    866.5040
    Why did this record match?
    Product Code :

    DCF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The K-ASSAY® Microalbumin reagent is for the quantitative determination of human albumin in urine by immunoturbidimetric assay. Measurement of albumin in urine nids in the diagnosis of kidney dysfunction. FOR IN VITRO DIAGNOSTIC USE. K-ASSAY ® The Microalbumin Calibrator is for the calibration of the K-ASSAY® Microalbumin assay for quantifying albumin in urine speiment. FOR IN VITRO DIAGNOSTIC USE.
    Device Description
    Not Found
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    K Number
    K082251
    Device Name
    SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100
    Manufacturer
    BECKMAN COULTER, INC.
    Date Cleared
    2009-04-08

    (243 days)

    Product Code
    DCF
    Regulation Number
    866.5040
    Why did this record match?
    Product Code :

    DCF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MA reagent, when used in conjunction with SYNCHRON CX® System(s) and SYNCHRON CX® MA Calibrator, is intended for the quantitative determination of albumin (MA) concentration in human urine. Measurement of albumin in urine aids in the diagnosis of kidney dysfunction.
    Device Description
    Synchron Systems Microalbumin (MA) reagent is intended for the quantitative determination of albumin in urine. MA reagent is used to measure the albumin concentration by a turbidimetric method. In the reaction, albumin combines with specific antibody to form insoluble antigen-antibody complexes. The Synchron System(s) automatically proportions the appropriate sample and reagent volumes into the cuvette. The ratio used is one part sample to 24 parts reagent. The system monitors the change in absorbance at 380 nanometers. This change in absorbance is proportional to the concentration of albumin in the sample and is used by the system to calculate and express albumin concentration based upon a non-linear calibration curve.
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