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510(k) Data Aggregation

    K Number
    K001632
    Device Name
    OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009
    Manufacturer
    AVL SCIENTIFIC CORP.
    Date Cleared
    2000-06-19

    (24 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    AVL SCIENTIFIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000103
    Device Name
    AVL OPTI R ANALYZER
    Manufacturer
    AVL SCIENTIFIC CORP.
    Date Cleared
    2000-03-20

    (67 days)

    Product Code
    CHL
    Regulation Number
    862.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    AVL SCIENTIFIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993837
    Device Name
    AVL OPTI CRITICAL CARE ANALYZER
    Manufacturer
    AVL SCIENTIFIC CORP.
    Date Cleared
    1999-12-16

    (34 days)

    Product Code
    CGA, CDS
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    AVL SCIENTIFIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AVL OPTI Critical Care Analyzer is intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, glucose, urea (BUN), total hemoglobin content and oxygen saturation in samples of whole blood, serum, plasma or dialysate in either a traditional blood gas, clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.
    Device Description
    The AVL OPTI Critical Care Analyzer is a small [4.9 x 14.3 x 9.8 in, 10 lbs], instrument using optical fluorescence for the measurement of pH, PCO2, sodium, potassium, ionized calcium, choride. glucose and urea (BUN) of whole blood, plasma, serum or dialysate as appropriate. In addition, it uses scattering for the measurement of total hemoglobin and oxygen saturation. A disposable, single-use cassette containing six optical fluorescence sensors is packaged in a sealed foil pouch which bears a bar-coded label with calibration and identification information. The OPTI can perform up to 8 tests on a single sample, determined by the type of disposable cassette used.
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    K Number
    K990092
    Device Name
    AVL OMNI MODULAR ANALYZER
    Manufacturer
    AVL SCIENTIFIC CORP.
    Date Cleared
    1999-01-29

    (18 days)

    Product Code
    CHL, CDS, CEM, CGA, CGZ, GKF, GKR, GLY, JFP, JGS, KHP
    Regulation Number
    862.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    AVL SCIENTIFIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AVL OMNI™ Analyzer is intended to be used for the measurement of pH , pCO2, pCO2 , sodium, potassium, ionized calcium, chloride, hematocrit and total hemoglobin and the hemoglobin derivatives: OzHb, COHb, MetHb, HHb, SulfHb and metabolites; glucose, lactate and urea nitrogen in samples of whole blood, serum, plasma, aqueous solutions as appropriate, in a clinical laboratory setting by personnel minimally qualified to perform and to report these results.
    Device Description
    The AVL OMNI™ Analyzer is a fully-automatic, microprocessor-controlled system that can perform up to 17 tests per sample.
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    K Number
    K984299
    Device Name
    AVL OPTI CRITICAL CARE ANALYZER
    Manufacturer
    AVL SCIENTIFIC CORP.
    Date Cleared
    1998-12-11

    (10 days)

    Product Code
    JFP, CGZ, CHL, GKR, GLY, JGS
    Regulation Number
    862.1145
    Why did this record match?
    Applicant Name (Manufacturer) :

    AVL SCIENTIFIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AVL OPTI Critical Care Analyzer is intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium and chloride, total hemoglobin content and oxygen saturation in samples of whole blood, serum, plasma or dialysate in either a traditional blood gas, clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results. The AVL OPTI Critical Care Analyzer intended to be used for the measurement of pH, PCO2, PO2, ctHb, SO2, Na', K', Cl' and Ca* in whole blood, serum, plasma and aqueous dialysate solutions as appropriate by minimally trained personnel qualified to perform and to report these values in either a traditional blood gas, clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results. For Professional Use Only For In Vitro Diagnostic Use
    Device Description
    The AVL OPTI Critical Care Analyzer is a small [4.9 x 14.3 x 9.8 in. 10 lbs], instrument using optical fluorescence for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium and choride of whole blood, plasma, serum or dialysate as appropriate. In addition, it uses optical reflectance for the measurement of total hemoglobin and oxygen saturation. A disposable, single-use cassette containing six optical fluorescence sensors is packaged in a sealed foil pouch which bears a bar-coded label with calibration and identification information. The OPTI can perform up to 8 tests on a single sample, determined by the type of disposable cassette used.
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    K Number
    K974784
    Device Name
    AVL OPTI CRITICAL CARE ANALYZER
    Manufacturer
    AVL SCIENTIFIC CORP.
    Date Cleared
    1998-02-24

    (64 days)

    Product Code
    CEM, CHL, GKR, GLY, JGS
    Regulation Number
    862.1600
    Why did this record match?
    Applicant Name (Manufacturer) :

    AVL SCIENTIFIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AVL OPTI Critical Care Analyzer is intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, total hemoglobin content and oxygen saturation in samples of whole blood, serum, and plasma in either a traditional blood gas, clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.
    Device Description
    The AVL OPTI Critical Care Analyzer is a small [4.9 x 14.3 x 9.8 in, 10 lbs], instrument using optical fluorescence for the measurement of pH, PCO2, PO2, sodium and potassium of whole blood, plasma or serum as appropriate. In addition, it uses optical reflectance for the measurement of total hemoglobin and oxygen saturation. A disposable, single-use cassette containing six optical fluorescence sensors is packaged in a sealed foil pouch which bears a bar-coded label with calibration and identification information. The OPTI can perform up to 7 tests on a single sample, determined by the type of disposable cassette used.
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    K Number
    K974822
    Device Name
    AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL
    Manufacturer
    AVL SCIENTIFIC CORP.
    Date Cleared
    1998-01-22

    (29 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    AVL SCIENTIFIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AVL OPTI-check assayed control is intended to be used to monitor the measurement of pH, PCO2, PO2, sodium, potassium, total hemoglobin content and oxygen saturation in the AVL OPTI Critical Care Analyzer, as well as other devices measuring the same parameters and ionized calcium and chloride. For In Vitro Diagnostic Use The determination of acid-base status, and concentration of carbon dioxide, oxygen, electrolytes, total hemoglobin and oxygen saturation is an important adjunct to patient monitoring for a variety of clinical conditions described in the labeling for those devices used for these purposes. Since therapeutic regimes are often determined by the results obtained in patient samples, the instruments used for these analyses must meet stringent requirements for accuracy and precision of measurement. It should be the goal of the quality control program in institutions performing these analyses to determine the instrumentation is working properly before the analysis and report of patient specimens, or after any suspicious results have been obtained.
    Device Description
    OPTI-check is a specially formulated aqueous liquid material intended to for use to monitor all analytes measured by the OPTI. It contains a stable suspension of polystyrene microbeads which reflect and partially absorb red and infrared light similar to erythrocytes, allowing true simulation of the measurement of tHb and SO2 in exactly the same manner as these analytes are determined in whole blood by the AVL OPTI Critical Care Analyzer. The three control levels contain three different concentrations of microbeads to simulate low, medium, and high hematocrit blood samples. OPT-check provides a convenient method of performing daily QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program. While the product is optimized for performance on the AVL OPTI Critical Care Analyzer, it may be used to monitor the measurement of blood gas and electrolyte values in conventional instrumentation. OPTI-check contains clinically relevant quantities of pH, PCO2, PO2, sodium, potassium, ionized calcium and chloride, and suitable concentrations of microbeads to simulate clinically relevant values of tHb and oxygen saturation.
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    K Number
    K972733
    Device Name
    AVL OMNI ANALYZER
    Manufacturer
    AVL SCIENTIFIC CORP.
    Date Cleared
    1997-09-09

    (50 days)

    Product Code
    CGA, CGZ, CHL, GHS, GLY, JFP, JGS
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    AVL SCIENTIFIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AVL OMNI™ Analyzer is intended to be used for the measurement of pH , pCO2, pCO2 , sodium, potassium, ionized calcium, chloride, hematocrit and total hemoglobin and the hemoglobin derivatives: OzHb, COHb, MetHb, HHb,SulfHb and metabolites; glucose and lactate in samples of whole blood, serum, plasma, aqueous solutions as appropriate, in a clinical laboratory setting by personnel minimally qualified to perform and to report these results. The AVL OMNI™ is a modular Critical Care Analyzer intended to be used for the measurement of pH, PCO2, PO2, ctHb, HHb, O2Hb, COHb, MetHb, SulfHb, Nat, K+, CI, ionized Ca*, Hematocrit, glucose and lactate in whole blood, serum, plasma, dialysate and QC materials as appropriate by minimally trained personnel qualified to perform and to report these values in a clinical laboratory setting.
    Device Description
    The AVL OMNI™ Analyzer is a fully-automatic, microprocessor-controlled system that can perform up to 16 tests per sample.
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    K Number
    K972673
    Device Name
    AVL 9181 ELECTROLYTE ANALYZER
    Manufacturer
    AVL SCIENTIFIC CORP.
    Date Cleared
    1997-08-20

    (35 days)

    Product Code
    JFP, CEM, CGZ, JGS, JIH
    Regulation Number
    862.1145
    Why did this record match?
    Applicant Name (Manufacturer) :

    AVL SCIENTIFIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AVL 9181 Electrolyte Analyzer is intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lithium in whole blood, serum or plasma, urine, dialysate solutions, or QC materials as appropriate by minimally trained personnel qualified to perform and to report these values in a clinical laboratory setting. These analytes are commonly used in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders and, as such, have come to be among those which are considered by the American Association of Clinical Chemistry to have the potential of being life threatening if left uncontrolled.
    Device Description
    The AVL 9181 Electrolyte Analyzer is a microprocessor-based instrument using ionselective electrodes for the measurement of sodium, chloride, ionized calcium and lithium. The user is able to select any one of the measurement modes: whole blood, serum, urine, standard, OC material, acetate or bicarbonate dialysate, depending on the sample type to be analyzed. The analyzer automatically processes the sample through the necessary steps, then prints and displays the results. The AVL 9181 is an improved design of our existing 9180 Electrolyte Analyzer [K961458] with the addition of an Autosampler to allow automatic sampling of up to 18 sample cups. The 9181 is exactly equivalent to the AVL 9180 with the exception of this single, additional feature. The manual needle mechanism of the 9180 was replaced with the automated needle mechanism from the AVL 988-4. The electronic circuitry to control the needle mechanism are incorporated into the 9180 display board. The sampler is taken from the 988-4 without modification except that the connector is changed to a smaller type. The 9180 main board already incorporated the controller for the sampler. The 9180 software was modified to add the automatic sampling feature. Calibration and measurement sequences are taken without alteration from the 9180 (sample volume, timing and algorithms). Once the sample probe is positioned in the sample cup, aspiration, measurement, wash and recalibration sequences are identical to the 9180.
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    K Number
    K963964
    Device Name
    AVL COMPACT 3 PH/BLOOD GAS ANALYZER
    Manufacturer
    AVL SCIENTIFIC CORP.
    Date Cleared
    1996-11-29

    (58 days)

    Product Code
    CHL
    Regulation Number
    862.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    AVL SCIENTIFIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AVL COMPACT 3 pH / Blood Gas Analyzer is intended to be used for the measurement of pH, PCO2 and PO2 in samples of whole blood.
    Device Description
    The AVL COMPACT 3 pH / Blood Gas Analyzer is a fully automatic, microprocessor-controlled medical instrument that measures pH, PCO2 and PO2. Communication to the device is accomplished simply with the use of a keypad. The analyzer communicates to the user through a 4-line alphanumeric display with 20 characters per line and with a thermal printer using heat sensitive paper to output measured values, calibration reports, electrode voltages and other information.
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