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510(k) Data Aggregation

    K Number
    K130990
    Device Name
    VARIANT(TM) II TURBO HBA1C KIT - 2.0
    Manufacturer
    BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS
    Date Cleared
    2013-05-09

    (29 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bio-Rad VARIANT™ II TURBO HbA Ic Kit - 2.0 is intended for the quantitative determination of hemoglobin Alc in human whole blood using ion-exchange high performance liquid chromatography (HPLC) on the VARIANT II TURBO Hemoglobin Testing System. Measurement of hemoglobin Alc is effective in monitoring long term glycemic control in individuals with diabetes mellitus. The Bio-Rad VARIANT II TURBO HbAlc Kit - 2.0 is intended for professional Use.
    Device Description
    The VARIANT II TURBO Hemoglobin Testing System is the next generation HPLC system with higher volume capability when compared to the VARIANT II testing system. The VARIANT II TURBO Hemoglobin Testing System provides an integrated method for sample preparation, separation, and determination of specific hemoglobin in whole blood. It is a fully automated, high-throughput system. It consists of 2 modules: the VARIANT II TURBO Sampling Station (VSS) and the VARIANT II TURBO Chromatographic Station (VCS). A personal computer (PC) is used to control the VARIANT II TURBO System using Clinical Data Management (CDM™) software. The CDM software supports import of sample information from and export of patient results to a Laboratory Information System (LIS). Control results are displayed on Levy-Jennings Charts and are exportable to Unity Real Time™.
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    K Number
    K130860
    Device Name
    VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE
    Manufacturer
    BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS
    Date Cleared
    2013-04-25

    (28 days)

    Product Code
    LCP, JPD
    Regulation Number
    864.7470
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bio-Rad VARIANT™ II Hemoglobin A Ic Program is intended for the percent determination of hemoglobin A Ic in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad VARIANT II Hemoglobin Alc Program is intended for Professional Use Only. For in vitro diagnostic use. Measurement of percent hemoglobin A1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus. The VARIANT™ II ß-thalassemia Short Program is intended for the separation and area percent determinations of hemoglobins A2 and F, and as an aid in the identification of abnormal hemoglobins in whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad VARIANT II ß-thalassemia Short Program is intended for use only with the Bio-Rad VARIANT II Hemoglobin Testing System. For in vitro diagnostic use. Measurement of the percent hemoglobin A2 and F are effective in screening of ß-thalassemia (i.e., hereditary hemolytic anemias characterized by decreased synthesis or more types of abnormal hemoglobin polypeptide chains).
    Device Description
    The VARIANT II Hemoglobin Testing System is a fully automated, highthroughput hemoglobin analyzer. The VARIANT II Hemoglobin Testing System provides an integrated method for sample preparation, separation and determination of the relative percent of specific hemoglobin in whole blood. It consists of two modules - the VARIANT II Chromatographic Station (VCS) and the VARIANT II Sampling Station (VSS). In addition, a personal computer is used to control the VARIANT System using Clinical Data Management (CDM) Software. A personal computer (PC) is used to control the VARIANT II Hemoglobin Testing System using Clinical Data Management (CDM™) software. The CDM software supports import of sample information from and export of patient results to a Laboratory Information System (LIS). Control results are displayed on Levy-Jennings Charts and are exportable to Unity Real Time™.
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    K Number
    K122472
    Device Name
    VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM
    Manufacturer
    BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS
    Date Cleared
    2012-10-26

    (73 days)

    Product Code
    LCP, ASS
    Regulation Number
    864.7470
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bio-Rad VARIANT™ II TURBO HbA1c Kit - 2.0 is intended for the quantitative determination of hemoglobin A1c in human whole blood using ion-exchange high performance liquid chromatography (HPLC) on the VARIANT™ II TURBO Hemoglobin Testing System. Measurement of hemoglobin A1c is effective in monitoring long term glycemic control in individuals with diabetes mellitus. The Bio-Rad VARIANT™ II TURBO HbA1c Kit-2.0 is intended for Professional Use Only.
    Device Description
    The VARIANT II TURBO Hemoglobin Testing System uses the principles of high performance liquid chromatography (HPLC). The VARIANT II TURBO HbA12 Kit - 2.0 is based on chromatographic separation of Hemoglobin A10 on a cation exchange cartridge. The VARIANT II TURBO HbA1c Kit - 2.0 contains an analytical cartridge, 5 prefilters, Elution Buffer A and B, Calibrator Level 1, Calibrator Level 2, Whole Blood Primer, sample vials and a CD-ROM with test parameters. The VARIANT II TURBO Hemoglobin Testing System provides an integrated method for sample preparation, separation and the quantitative determination of HbAle in EDTA human whole blood. The VARIANT II TURBO Hemoglobin Testing System is a fully automated, high-throughput hemoglobin analyzer. It consists of two modules - the VARIANT II Chromatographic Station (VCS) and the VARIANT II Sampling Station (VSS). There have been hardware updates due to obsolescence of parts and firmware updates to support the replacement hardware components. A personal computer is used to control the VARIANT II TURBO Hemoglobin Testing System using updated Clinical Data Management (CDM) software version 5.1.1.
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