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510(k) Data Aggregation

    K Number
    K191298
    Device Name
    i-STAT CHEM8+ cartridge with the i-STAT 1 System
    Manufacturer
    Abbott Point of Care Inc.
    Date Cleared
    2020-02-07

    (269 days)

    Product Code
    JFL
    Regulation Number
    862.1160
    Why did this record match?
    Product Code :

    JFL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The i-STAT CHEM8+ cartridge with the i-STAT 1 System is in the in vitro quantification of total carbon dioxide in arterial or venous whole blood in point of care or clinical laboratory settings. Carbon dioxide measurements are used in the diagnosis, monitoring, and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
    Device Description
    The i-STAT CHEM8+ test cartridge contains test reagents to analyze whole blood at the point of care or in the clinical laboratory for total carbon dioxide (TCO2). The test is contained in a single-use, disposable cartridge. Cartridges require two to three drops of whole blood which are typically applied to the cartridge using a transfer device. The i-STAT 1 Analyzer is a handheld, in vitro diagnostic analytical device designed to run only i-STAT test cartridges. The instrument interacts with the cartridge to move fluid across the sensors and generate a quantitative result (within approximately 2 minutes). The i-STAT 1 System is comprised of the i-STAT 1 analyzer, the i-STAT test cartridges and accessories (i-STAT 1 Downloader/Recharger, electronic simulator and portable printer). The system is designed for use by trained medical professionals at the patient point of care or in the clinical laboratory and is for prescription use only.
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    K Number
    K040975
    Device Name
    GENCHEM CO2 ACID REAGENT
    Manufacturer
    GENCHEM, INC.
    Date Cleared
    2004-12-27

    (257 days)

    Product Code
    JFL
    Regulation Number
    862.1160
    Why did this record match?
    Product Code :

    JFL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GenChem CO2 Acid Reagent when used in conjunction with the GenChem ISE Electrolyte Reference, GenChem Electrolyte Buffer, GenChem CO2 Alkaline Buffer, GenChem Wash Concentrate, and appropriate Calibrators or Calibration Standards is intended for the quantitative determination of Carbon Dioxide in serum and plasma on the Beckman CX3®. Carbon Dioxide results are used in the diagnosis and treatment of numerous and potentially serious disorders associated with changes in the body's acidbase balance.
    Device Description
    The Device is a solution containing 0.6 mol/L sulfuric acid, nonreactive surfactants and other ingredients necessary for optimum system operation.
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    K Number
    K014034
    Device Name
    MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)
    Manufacturer
    BECKMAN COULTER, INC.
    Date Cleared
    2001-12-18

    (11 days)

    Product Code
    JFL, CEM, CGZ, JFP, JGS
    Regulation Number
    862.1160
    Why did this record match?
    Product Code :

    JFL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SYNCHRON LX Clinical Systems are fully automated, computer controlled, clinical chemistry analyzers intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, and cerebral spinal fluid (sample type is chemistry dependant). SYNCHRON LX ISE Electrolyte Buffer Reagent, SYNCHRON LX ISE Electrolyte Reference Reagent, and CO2 Alkaline Buffer and Acid Reagent, in conjunction with SYNCHRON LX AQUA CAL 1 and 3, are intended for quantitative determination of carbon dioxide (CO2) in serum or plasma on SYNCHRON LX Systems. SYNCHRON LX ISE Electrolyte Buffer Reagent and SYNCHRON LX ISE Electrolyte Reference Reagent, in conjunction with SYNCHRON LX AQUA CAL 1 and 2, are intended for quantitative determination of calcium (CALC) in serum, plasma or urine on SYNCHRON LX Systems. SYNCHRON LX ISE Electrolyte Buffer Reagent and SYNCHRON LX ISE Electrolyte Reference Reagent, in conjunction with SYNCHRON LX AQUA CAL 1 and 2, are intended for quantitative determination of chloride (CL) in serum, plasma, urine or cerebrospinal fluid (CSF) on SYNCHRON LX Systems. SYNCHRON LX ISE Electrolyte Buffer Reagent and SYNCHRON LX ISE Electrolyte Reference Reagent, in conjunction with SYNCHRON LX AQUA CAL 1, 2 and 3, are intended for the quantitative determination of potassium (K) in serum, plasma or urine on the SYNCHRON LX System. SYNCHRON LX ISE Electrolyte Buffer Reagent and SYNCHRON LX ISE Electrolyte Reference Reagent, in conjunction with SYNCHRON LX AQUA CAL 1, 2 and 3, are intended for the quantitative determination of sodium (NA) in serum, plasma or urine on the SYNCHRON LX System.
    Device Description
    The SYNCHRON LX Clinical Systems are fully automated, computer controlled, clinical chemistry analyzers intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, and cerebral spinal fluid (sample type is chemistry dependent). The analyzers operate in conjunction with reagents, calibrators, and controls designed for use with the system. The instruments feature bar code identification of samples and reagents. Thev automatically dilute samples and deliver them to the associated reaction vessel for each system module (cuvette, cup, or ISE flowcell) along with reagents and reaction constituents. The systems analyze up to 41 analytes per sample. Major hardware components include a reagent compartment, sample and reagent cranes, cartridge chemistry section, modular chemistry section, sample carousel and crane, hydropneumatics, electronics, and power supplies. The LX20 PRO is differentiated from the standard LX20 system with the following hardware: LPIA (Large Particle Immunoassay) Module and TS-CTS (Thick Stopper-Closed Tube Sampling) Module The fixed menu ISE flow cell module is contained in the modular chemistry area. The ISE flow cell contains ISE electrodes for the measurement of Sodium (NA), Potassium (K), Chloride (CL), carbon dioxide (CO2), and Calcium (CALC). The modified SYNCHRON LX Systems utilize a new ISE (Ion Selective Electrode) sample volume of 40 µL. The prior sample volume was 62µL.
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    K Number
    K963541
    Device Name
    SIGMA DIAGNOSTICS CO2 ACID REAGENT
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    1996-10-24

    (50 days)

    Product Code
    JFL
    Regulation Number
    862.1160
    Why did this record match?
    Product Code :

    JFL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used to measure carbon dioxide concentrations in serum or plasma on the SYNCHRON CX®3 System.
    Device Description
    CO2 Acid Reagent, Procedure Number C7558
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    K Number
    K963538
    Device Name
    SIGMA DIAGNOSTICS CO2ALKALINE BUFFER
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    1996-10-11

    (37 days)

    Product Code
    JFL
    Regulation Number
    862.1160
    Why did this record match?
    Product Code :

    JFL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    to measure carbon dioxide concentrations in serum or plasma on the SYNCHRON CX 3 System
    Device Description
    CO2 Alkaline Buffer, Procedure Number C7683
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    K Number
    K963540
    Device Name
    SIGMA DIAGNOSTICS ELECTROLYTE BUFFER
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    1996-09-27

    (23 days)

    Product Code
    JFL, CEM, CGZ, JGS
    Regulation Number
    862.1160
    Why did this record match?
    Product Code :

    JFL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Both electrolyte buffers are used to measure sodium, chloride, potassium, and carbon dioxide concentrations in serum or plasma, sodium, potassium, and chloride concentrations in urine, and chloride concentrations in CSF on the SYNCHRON CX 3 System
    Device Description
    The Sigma Diagnostics methods use ion selective electrodes for determining sodium, potassium, and chloride and rate of pH change for determing carbon dioxide on the SYNCHRON CX 3 System.
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    K Number
    K963005
    Device Name
    NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Date Cleared
    1996-08-23

    (21 days)

    Product Code
    JFL, CGL, CGZ, GKF
    Regulation Number
    862.1160
    Why did this record match?
    Product Code :

    JFL

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