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510(k) Data Aggregation

    K Number
    K013371
    Device Name
    UBIT-IR300 INFRARED SPECTROMETRY SYSTEM
    Manufacturer
    OTSUKA PHARMACEUTICAL CO., LTD.
    Date Cleared
    2001-12-21

    (71 days)

    Product Code
    JJQ, MSQ
    Regulation Number
    862.2300
    Why did this record match?
    Product Code :

    JJQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UBiT-IR300 Infrared Spectrometry System is an in vitro diagnostic device designed to measure changes in 1302 content in breath CO2 gas by infrared spectroscopic analysis. The system consists of the UBiT-IR300 Infrared Spectrophotometer, the UBiT-AS10 Autosampler, and Otsuka Breath Collection Bags. The UBiT-IR300 Infrared Spectrometry System is intended for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacter pylori (H. pylori) infection. The UBiT-IR300 System is suitable for use in both clinical laboratory and point-of-care settings.
    Device Description
    The UBiT-IR300 Infrared Spectrometry System is a compact analyzer designed for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacter pylori. The UBiT-IR300 measures absorption of breath gas by calculating the ratios of 13CO2/12CO2 for a reference breath gas and a sample breath gas. The difference between the ratios for the reference and sample breath gases is calculated to obtain the final measurement result, which is reported as △'3CO2 and expressed as delta per mil (%) or Delta Over Baseline (DOB). The System consists of the following components: - UBiT-IR300 Infrared Spectrophotometer - - UBiT-AS10 Autosampler - - Otsuka Breath Collection Bags -
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    K Number
    K980120
    Device Name
    DIGENE DML 2000 MICROPLATE LUMINOMETER
    Manufacturer
    DIGENE CORP.
    Date Cleared
    1998-02-06

    (24 days)

    Product Code
    JJQ, KHO
    Regulation Number
    862.2300
    Why did this record match?
    Product Code :

    JJQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Digene DML 2000 Microplate Luminometer is intended to measure light that is emitted as a result of a chemiluminescent reaction. Assay results obtained using chemiluminescence technology in 96 well microplates are calculated and interpreted according to assay validation parameters.
    Device Description
    The DML 2000 is a microplate luminometer capable of reading chemiluminescence from opaque microplates. Chemiluminescence is the production of light from a chemical reaction. The luminometer is optimally designed for measurement of glow type luminescence. The luminometer is designed to be run and controlled by a personal computer connected via a serial RS-232 interface port. The instrument is simple in design with measurement taking place in 96-well microplates, where each well is presented to the detector by stepper motors moving the plate. The light is detected by a photomultiplier tube. The light is amplified and converted to an electrical signal which is detected by a sensitive electrical amplifier. The detected signals are converted to Relative Light Units (RLU) and are reported for each well of the microplate. Assay results are calculated and interpreted according to assay validation parameters.
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    K Number
    K973938
    Device Name
    ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER
    Manufacturer
    SFRI, INC.
    Date Cleared
    1998-02-04

    (112 days)

    Product Code
    JJQ
    Regulation Number
    862.2300
    Why did this record match?
    Product Code :

    JJQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE ALPHA 4 LS IS INTENDED TO AUTOMATE MICROTITER PLATE PROCESSOR AND READER THAT MEASURES THE LIGHT ABORBANCE OR LUMINESCENCE OF REACTION PRODUCTS IN EITHER MODE.
    Device Description
    ALPHA 4 LS Automated Microtiterplate Processor and Reader
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    K Number
    K974762
    Device Name
    STAT TRACKS
    Manufacturer
    AWARENESS TECHNOLOGY, INC.
    Date Cleared
    1998-01-28

    (40 days)

    Product Code
    JJQ
    Regulation Number
    862.2300
    Why did this record match?
    Product Code :

    JJQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This accessory program may be used by customers with the general purpose analyzer (K882938) who want to link their instrument to a PC for the purpose of transferring the data from the general purpose instrument to the PC, instead of having the data typed manually by a data entry person
    Device Description
    Stat Tracks is a dedicated software interface and reporting tool comparable to any other commercially available software. It is also comparable to manual writing, graphing, and filing.
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    K Number
    K962113
    Device Name
    ANTHOS PHACTS VERSION MICROPLATE READER
    Manufacturer
    COLUMBIA BIOSCIENCE, INC.
    Date Cleared
    1996-11-05

    (158 days)

    Product Code
    JJQ
    Regulation Number
    862.2300
    Why did this record match?
    Product Code :

    JJQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Anthos PhACTS 2010 Microplate Reader is intended to be used as a general purpose microplate photometer for clinical use.
    Device Description
    The Anthos PhACTS 2010, 2001 and its predicate devices all share the same principle of operation. Briefly, each device provides a light source which is focused to provide illumination of wells in a microtiter plate. A corresponding silicon-photodiodes measures the amount of light absorbed by the sample as the light passes through the microplate well. The respective well absorbance measurements is used by the data reduction software to yield a specific well absorbance value which in turn can yield a qualitative or quantitative assay result.
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    K Number
    K961183
    Device Name
    CBI 7520 READER
    Manufacturer
    COLUMBIA BIOSCIENCE, INC.
    Date Cleared
    1996-08-02

    (129 days)

    Product Code
    JJQ
    Regulation Number
    862.2300
    Why did this record match?
    Product Code :

    JJQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CBI 7520 Microplate Reader is intended to be used as a general purpose microplate photometer for clinical use.
    Device Description
    The CBI 7520 microplate reader employs an automatic transport mechanism to bring the individual microplate wells into position for reading. The device employs Tungsten halogen lamp as the light source. The device uses silicon-photodiodes to measure the light absorbance.
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    K Number
    K962166
    Device Name
    ORIGEN ANALYZER
    Manufacturer
    IGEN, INC.
    Date Cleared
    1996-07-31

    (57 days)

    Product Code
    JJQ
    Regulation Number
    862.2300
    Why did this record match?
    Product Code :

    JJQ

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