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510(k) Data Aggregation

    K Number
    K023955
    Device Name
    BD VIPER INSTRUMENT
    Manufacturer
    BECTON, DICKINSON & CO.
    Date Cleared
    2003-06-24

    (209 days)

    Product Code
    JQW
    Regulation Number
    862.2750
    Why did this record match?
    Product Code :

    JQW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BD Viper"™ instrument is intended for use as a sample processor designed for use with the BD ProbeTec ™ ET system and the BD ProbeTec ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) assays. The BD Viper instrument automates the transfer and mixing of manually prepared and lysed samples. The BD Viper instrument incorporates heating blocks to perform assay priming and prewarming incubation steps prior to the removal and transfer of the microwells to the BD ProbeTec ET instrument for amplification and detection.
    Device Description
    The BD Viper is a sample processor designed for use with the BD ProbeTec ET system. The BD Viper automates the transfer and mixing of specimens that have been prepared and lysed according to the specific BD ProbeTec ET assay package insert. Automated specimen transfers by the BD Viper occur from the sample processing tubes to the assay priming microwells and from the priming microwells to the assay amplification microwells. The BD Viper also controls the incubation steps for priming the samples and pre-warming the amplification microwells. After the BD Viper transfers samples from the priming wells to the amplification microwells, the instrument mixes the contents of the amplification microwells. After mixing, the plates are manually sealed and removed from the BD Viper. The sealed plates are placed into the BD ProbeTec ET instrument(s) where the analyte specific amplification and detection process occurs. The BD Viper is comprised of four major components: robotic pipetting arm, priming and warming heaters, LCD monitor with integrated touch screen, and instrument software.
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    K Number
    K973335
    Device Name
    QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)
    Manufacturer
    ZENYX SCIENTIFIC LTD.
    Date Cleared
    1998-04-30

    (238 days)

    Product Code
    JQW
    Regulation Number
    862.2750
    Why did this record match?
    Product Code :

    JQW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quatro SP Series Robotic Sample Processing Systems and their accessories are provided as generic liquid handling systems which must be customized and validated for each user environment, according to in vitro diagnostic test instructions and requirements. The customization can be accomplished by users or can be provided, to customer specifications, by Zenyx authorized representatives.
    Device Description
    Quatro SP Series Sample Processing Systems are bench top, four probe, automated pipettor/dilutors of various sizes (capacities) which are programmed via keypad or personal computer. Optional system components include bar code readers, sample racks for tubes or microplates, workstations, and a washing module. Another option, Concerto software, allows control of the processor from a personal computer and extension of programming capabilities via menu-driven commands. The Quatro SP Series Sample Processing Systems use either stainless steel or teflon coated probe tips. The systems are supplied for generic liquid handing application and must be customized to each user's in vitro test specifications. Training is provided for users who wish to perform their own programming.
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    K Number
    K980180
    Device Name
    2700 SAMPLE MANAGER
    Manufacturer
    WATERS CORPORATION
    Date Cleared
    1998-02-12

    (23 days)

    Product Code
    JQW
    Regulation Number
    862.2750
    Why did this record match?
    Product Code :

    JQW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Waters 2700 Sample Manager is designed for use in a clinical laboratory to manage sample injection for high throughput LC and LCMS applications. The 2700 Sample Manager automates sample aspiration and injection from microtiter plates, test tubes, Eppendorf tubes, or conventional autosampler vials. This product is-intended for In Vitro Diagnostic Use.
    Device Description
    The Waters 2700 Sample Manager is designed for use in a clinical laboratory to manage sample injection for high throughput LC and LCMS applications. The 2700 Sample Manager automates sample aspiration and injection from microtiter plates, test tubes, Eppendorf tubes, or conventional autosampler vials.
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    K Number
    K970420
    Device Name
    MASTERCAP AM 5.0/MASTERCAP RM 5.0
    Manufacturer
    PHARMACIA, INC.
    Date Cleared
    1997-06-30

    (147 days)

    Product Code
    JQW
    Regulation Number
    862.2750
    Why did this record match?
    Product Code :

    JQW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MasterCAP AM 5.0 is a software tool for Assay Management designed to support the set up of an in vitro diagnostic assay run. It is designed to be used with Pharmacia CAP System diagnostic equipment and related devices. It is run either in Microsoft Windows, 3.x, or Windows '95 Environment. MasterCAP AM 5.0 handles sample lists, and creates worklists for the related Pharmacia & Upjohn diagnostic equipment. MasterCAP AM 5.0 also evaluates and calculates the assay results and generates laboratory reports. It can import and export results to main frame computers. MasterCAP AM 5.0 includes a driver function which can send and receive patient data from UniCAP 100 diagnostic equipment. MasterCAP RM 5,0 is a software tool for Request Management designed to be used together with MasterCAP AM 5.0. MasterCAP RM 5.0 includes a database and provides features for request management and data storage. MasterCAP RM handles requests and creates sample lists to be used in MasterCAP AM. When the data are evaluated, MasterCAP RM collects the results and generates a result report for each request. MasterCAP RM can store requests, requestor information and test panels, and also provides backup and restore functions.
    Device Description
    1. MasterCAP AM 5.0 is a software tool for assay management designed to support the set up of an in vitro diagnostic immunoassay. It is designed to be used with Pharmacia CAP System diagnostic equipment and related devices. It is run either in Microsoft Windows, 3.x or Windows '95 Environment. The following Pharmacia CAP System diagnostic equipment and related devices may be used with MasterCAP AM: AutoCAP, Positioning Guide 96, RoboCAP Version 2.0, Fluorocount 96, Assay Washer 96, UniCAP 100. When using the UniCAP 100 Device Driver Function of MasterCAP AM with UniCAP 100, you can transfer sample list data to, and import evaluated assay results from, one or more connected UniCAP 100 devices. MasterCAP AM 5.0 software directs the diagnostic equipment to perform the following functions: * import sample lists from a main frame computer or enter the information manually - * create an assay run - * distribute samples and tests - * process an assay - * collect raw data - * evaluate and calculate the results - * export the results to the main frame computer - * define assay methods and method groups 2. MasterCAP RM 5.Q is a software tool for Request Management designed to be used with MasterCAP AM 5.0 for laboratories running in vitro diagnostic assays. MasterCAP RM includes a database and provides features for request management and data storage. MasterCAP RM handles requests and creates sample lists to be used in MasterCAP AM. When the data are evaluated, MasterCAP RM collects the results and generates a result report for each request. MasterCAP AM and MasterCAP RM are designed to be used with Pharmacia CAP System and UniCAP 100 diagnostic equipment and related devices. MasterCAP RM can perform the following functions: - * create sample lists - * store requests, requester information and test panels - * create laboratory, result and patient test reports - * perform database queries - * provide backup and restore functions
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    K Number
    K970616
    Device Name
    MINI SAMPLER PROCESSOR
    Manufacturer
    CAVRO SCIENTIFIC INSTRUMENTS, INC.
    Date Cleared
    1997-04-21

    (62 days)

    Product Code
    JQW
    Regulation Number
    862.2750
    Why did this record match?
    Product Code :

    JQW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is intended to be used for automating sample preparation or assay methods and is capable of aspirating, dispensing or diluting fluids to any position on the instruments work area.
    Device Description
    The MSP 9500 Mini Sample Processor is a microprocessor controlled pipetting and diluting system. It is designed to be used for automating sample preparation or assay methods. It is capable of aspirating, dispensing or diluting to any position on the instrument work area. An XYZ robotic positioner moves the pipetting and dispensing tip to the desired XY position then lowers it in the Z direction into the sample. A fluid pump is then used to either aspirate or dispense the desired quantity of sample or reagent. The unit is modular, allowing customization for specific applications. It consists of an enclosure, one or two XYZ robotic modules, power supply, central controller unit, connector for interfacing with an external computer, one or more fluid pumps and may be configured with a variety of optional pumps. valves and accessories. Modular racks will accommodate many types of commonly used tubes and microwell plates. It may be private labeled to meet individual needs.
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    K Number
    K962687
    Device Name
    GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM
    Manufacturer
    NICHOLS INSTITUTE DIAGNOSTICS
    Date Cleared
    1997-03-28

    (260 days)

    Product Code
    JQW
    Regulation Number
    862.2750
    Why did this record match?
    Product Code :

    JQW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K962859
    Device Name
    MINI SAMPLE PROCESSOR
    Manufacturer
    CAVRO SCIENTIFIC INSTRUMENTS, INC.
    Date Cleared
    1996-10-29

    (99 days)

    Product Code
    JQW
    Regulation Number
    862.2750
    Why did this record match?
    Product Code :

    JQW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K961896
    Device Name
    MICROLAB 4000, MICROLAB 4200
    Manufacturer
    HAMILTON CO.
    Date Cleared
    1996-08-16

    (92 days)

    Product Code
    JQW
    Regulation Number
    862.2750
    Why did this record match?
    Product Code :

    JQW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K961694
    Device Name
    IMPACT
    Manufacturer
    MATRIX TECHNOLOGIES CORP.
    Date Cleared
    1996-06-21

    (51 days)

    Product Code
    JQW
    Regulation Number
    862.2750
    Why did this record match?
    Product Code :

    JQW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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