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510(k) Data Aggregation

    K Number
    K120900
    Device Name
    I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2
    Manufacturer
    CLINIQA CORPORATION
    Date Cleared
    2013-05-31

    (431 days)

    Product Code
    GGN
    Regulation Number
    864.5425
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLINIQA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The i-STAT PT Control Level 1 (normal) and PT Control Level 2 (abnormal) are used for quality control of i-STAT PT cartridges on i-STAT handheld and wireless systems. The i-STAT ACT Control Level 1 (normal) and ACT Control Level 2 (abnormal) are used for quality control of i-STAT ACT cartridges on i-STAT handheld and wireless systems.
    Device Description
    Not Found
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    K Number
    K121237
    Device Name
    BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE
    Manufacturer
    CLINIQA CORPORATION
    Date Cleared
    2012-05-18

    (24 days)

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

    CLINIQA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cliniqa Beta HCG Controls, Levels 1, 2, and 3 and Cliniqa Beta HCG Calibration Verification Controls, Levels 1, 2, and 3 are assayed quality control materials used to monitor the precision of Beta HCG assays.
    Device Description
    Cliniqa Beta HCG Control is prepared from human serum and purified human antigens. Preservatives and stabilizers have been added to maintain product integrity. CLINIQA Beta HCG Control a ready-to-use liguid control requiring no reconstitution or frozen storage. Cliniqa Beta HCG Calibration Verification Control is prepared from human serum and purified human antigens. Preservatives and stabilizers have been added to maintain product integrity. CLINIQA Beta HCG Calibration Verification Control a ready-to-use liquid control requiring no reconstitution or frozen storage.
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    K Number
    K083554
    Device Name
    CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3
    Manufacturer
    CLINIQA CORPORATION
    Date Cleared
    2009-04-21

    (141 days)

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

    CLINIQA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CLINIQA® Liquid QC™ ImmunoAssay Controls, Levels 1, 2, & 3 are assayed, liquid, quality control products which may be used to evaluate the assaycu, liquid, quality control procuments an analytes listed in the product insert.
    Device Description
    assayed, liquid, quality control products
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    K Number
    K081908
    Device Name
    CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2
    Manufacturer
    CLINIQA CORPORATION
    Date Cleared
    2009-01-16

    (197 days)

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

    CLINIQA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CLINIQA® Liquid QC™ DipScopics Urinalysis Control is intended for use as an assayed quality control material for various urinalysis reagent strips, qualitative hCG methods as well as confirmatory tests such as Acetest®, Clinitest", and Ictotest This control is also intended to evaluate microscopic examination test procedures
    Device Description
    Not Found
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    K Number
    K082107
    Device Name
    CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2
    Manufacturer
    CLINIQA CORPORATION
    Date Cleared
    2008-09-17

    (54 days)

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

    CLINIQA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CLINIQA® Liquid QC™ Urine Chemistry Controls, Levels 1 and 2 are intended for use as an assayed quality control material. It is not intended for use as a standard. Assay values for analytes listed in this product insert are provided for both levels.
    Device Description
    Not Found
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    K Number
    K080973
    Device Name
    CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC
    Manufacturer
    CLINIQA CORPORATION
    Date Cleared
    2008-06-02

    (59 days)

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

    CLINIQA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CLINIQA® Liquid QC™ Complete Cardiac Marker Control Levels 1, 2, and 3 is intended for use as an assayed quality control material for cardiac markers listed in the product insert. CLINIQA Liquid QC Complete Cardiac Marker Control is not intended for uroud a standard. LiniCAL Cardiac Marker Calibration Verifiers are intended for use in the clinical laboratory to verify calibration and/or assess linearity of the analyzers listed in the product insert. Four assayed levels of analytes listed in the product inert are provided to allow monitoring of the reportable range. CLINIQA Liquid QC Cardiac Marker Controls, Low is intended for use as an assayed quality control material for cardiac markers listed in the product insert. CLINIQA Liguid QC Complete Cardiac Marker Control is not intended for use as a standard.
    Device Description
    Not Found
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    K Number
    K070741
    Device Name
    CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3
    Manufacturer
    CLINIQA CORPORATION
    Date Cleared
    2007-05-04

    (49 days)

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

    CLINIQA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CLINIQA® Liquid QC™ Assayed General Chemistry Control is intended for use as an assayed quality control material for the contituents listed in this package insert.
    Device Description
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    K Number
    K062916
    Device Name
    CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3
    Manufacturer
    CLINIQA CORPORATION
    Date Cleared
    2006-10-23

    (25 days)

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

    CLINIQA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CLINIQA Liquid QC Cardiac Marker Control SP, Levels 1, 2, & 3 are intended for use as assayed quality control material for CK-MB, hs-CRP, Digoxin, Myoglobin, cTnl, Troponin T, and NT ProBNP analysis.
    Device Description
    Not Found
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    K Number
    K061182
    Device Name
    CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS;QALIB
    Manufacturer
    CLINIQA CORPORATION
    Date Cleared
    2006-05-25

    (28 days)

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

    CLINIQA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CLINIQA Liquid QC Lipid Controls Levels 1 and 2 are intended for use as assayed quality control material for Apolipoprotein A-1, Apolipoprotein B, Cholesterol (total), High Density Lipoprotein, Low Density Lipoprotein and Triglyceride analysis. CLINIQA LiniCAL Lipid Calibration Verifiers Levels A - E for Olympus AU Systems are assayed, liquid, quality control products which may be used to evaluate the performance of the Olympus AU Systems for Cholesterol (total), High Density Lipoprotein. Low Density Lipoprotein and Triglyceride at five useful concentrations. CLINIQA QALIBRATE™ - Lipid Calibrator is intended for use in assay method calibration for clinical chemistry analyzers listed in the product insert.
    Device Description
    Not Found
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    K Number
    K060322
    Device Name
    CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED
    Manufacturer
    CLINIQA CORPORATION
    Date Cleared
    2006-03-21

    (40 days)

    Product Code
    JIT, JJY
    Regulation Number
    862.1150
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLINIQA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CLINIQA Dry QC™ Chemistry Control, Levels 1 and 2 (Assayed ), is intended for use as an assayed quality control material. Two levels of the control are provided. CLINIQA Dry QC™ Chemistry Control, Levels 1 and 2 (Unassayed) is intended for use as a quality control material. Two levels of the control are provided. CLINIQA QALIBRATE™ - CH Chemistry Calibrator is intended for use in assay method calibration for clinical chemistry analyzers .
    Device Description
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