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510(k) Data Aggregation

    K Number
    K142262
    Device Name
    AUTION CHECK PLUS
    Manufacturer
    QUANTIMETRIX CORP.
    Date Cleared
    2015-04-10

    (239 days)

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

    QUANTIMETRIX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AUTION CHECK Plus is a quality control material intended for in vitro diagnostic use only, for performing quality control procedures with Arkray urine test strips and analyzers.
    Device Description
    The AUTION CHECK Plus, is a two level liquid control prepared from human urine source material with added stabilizers and preservatives. Level 1 is positive for bilirubin and urobilinogen and Level 2 is positive for glucose, protein, blood, ketone, nitrite and leukocytes.
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    K Number
    K113177
    Device Name
    COMPLETE D 25-OH VITAMIN D CONTROL
    Manufacturer
    QUANTIMETRIX CORP.
    Date Cleared
    2012-05-10

    (195 days)

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

    QUANTIMETRIX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantimetrix Complete D® 25-OH Vitamin D Control is intended for the quality control of laboratory procedures used to quantitate Total 25-OH Vitamin D.
    Device Description
    This quality control product is intended to allow an objective measurement of a laboratories performance (procedures and personnel techniques) in comparison to known values. Two clinically relevant levels of controls are available to compare observations with expected ranges therefore assuring consistent performance.
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    K Number
    K103744
    Device Name
    DROPPER A1C DIABETES CONTROL
    Manufacturer
    QUANTIMETRIX CORP.
    Date Cleared
    2011-05-12

    (140 days)

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

    QUANTIMETRIX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantimetrix Dropper Alc Diabetes Control is intended for the quality control of laboratory procedures used to quantitate HbA1c.
    Device Description
    Dropper A1c Controls are supplied in two levels, 4 bottles total, 2 x 2 mL each level per box. The controls are supplied as a ready-to-use frozen liquid, requiring no reconstitution or dilution. They are prepared in a whole blood matrix fortified to target levels with reagent grade chemicals added to achieve the two levels. Preservatives have been added to inhibit microbial growth.
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    K Number
    K062942
    Device Name
    QUANTIMETRIX NICOSURE COTININE URINE CONTROL
    Manufacturer
    QUANTIMETRIX CORP.
    Date Cleared
    2006-10-30

    (32 days)

    Product Code
    LAS
    Regulation Number
    862.3280
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUANTIMETRIX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantimetrix Corp. NiCosure Cotinine Urine Control is intended as a means of monitoring the performance of GC/MS and other drugs of Cotinine methods used for detecting the Cotinine levels in unknown urine specimens. Use of quality control materials is an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method.
    Device Description
    Not Found
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    K Number
    K062751
    Device Name
    MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER
    Manufacturer
    QUANTIMETRIX CORP.
    Date Cleared
    2006-10-03

    (19 days)

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

    QUANTIMETRIX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantimetrix Corp. Cardiasure Cardiac Markers Control is intended as a means of monitoring serum cardiac analyte monitoring methods to validate measurement of patient serum samples. Use of quality control materials is an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method.
    Device Description
    Not Found
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    K Number
    K060417
    Device Name
    MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL
    Manufacturer
    QUANTIMETRIX CORP.
    Date Cleared
    2006-03-21

    (32 days)

    Product Code
    DIF
    Regulation Number
    862.3280
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUANTIMETRIX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantimetrix Corp. Drug of Abuse Urine Screen Control is intended to be used as a means of monitoring the performance of Abuscreen ONLINE, AxSYM, Triage and other drugs of abuse screening methods used for detecting drugs in unknown urine specimens.
    Device Description
    Not Found
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    K Number
    K032791
    Device Name
    GLYCOHEMOSURE HBA1C CONTROL
    Manufacturer
    QUANTIMETRIX CORP.
    Date Cleared
    2003-10-30

    (52 days)

    Product Code
    GGM
    Regulation Number
    864.8625
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUANTIMETRIX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantimetrix GlycoHemosure is intended for the quality control of laboratory procedures for the quantitation of HbA1c.
    Device Description
    The Quantimetrix GlycoHemosure is supplied liquid in glass bottles. It consists of humansource blood that was treated to give a stable liquid formulation of two distinct levels of HbA1c.
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    K Number
    K030826
    Device Name
    PRECISET DAT AMPHETAMINE
    Manufacturer
    QUANTIMETRIX CORP.
    Date Cleared
    2003-04-03

    (20 days)

    Product Code
    DIJ
    Regulation Number
    862.3550
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUANTIMETRIX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Preciset DAT Amphetamine calibrators are designed for the calibration of the Roche Abuscreen® OnLine assays for Amphetamines and the cassette COBAS INTEGRA® Amphetamines (AMPS) for the determination of amphetamines in human urine on automated clinical chemistry analyzers.
    Device Description
    The Quantimetrix Preciset® DAT Amphetamine drug of abuse calibrator and controls are supplied liquid in a glass bottle. They consist of drug-free human urine to which preservative, stabilizer and drug analyte have been added to achieve distinctive levels. The drug added is: d-amphetamine. Drug concentration is determined using GC/MS.
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    K Number
    K021393
    Device Name
    PRECISET DAT PLUS
    Manufacturer
    QUANTIMETRIX CORP.
    Date Cleared
    2002-06-13

    (42 days)

    Product Code
    DKB
    Regulation Number
    862.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUANTIMETRIX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Preciset DAT Plus calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.
    Device Description
    The Quantimetrix Preciset® DAT Plus drug of abuse calibrator is supplied liquid in a glass bottle. It consists of drug-free human urine to which preservative, stabilizer and drugs of abuse have been added to achieve six distinct levels. The drugs added are: metamphetamine, nordiazepam, barbiturates, cocaine metabolites, methadone, morphine, phencyclidine, propoxyphene, cannabinoids. Drug concentrations are determined using GC/MS.
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    K Number
    K013662
    Device Name
    MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS
    Manufacturer
    QUANTIMETRIX CORP.
    Date Cleared
    2002-03-08

    (122 days)

    Product Code
    JHO
    Regulation Number
    862.1475
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUANTIMETRIX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantimetrix Lipoprint™ System LDL Subfractions is a device intended to measure lipoprotein cholesterol (for lipoprotein fractions and subfractions) in fasting serum or plasma with a Total Cholesterol concentration of ≥ 100 mg/dl. Lipoprotein cholesterol measurements are used as an aid in evaluating lipid metabolism disorders when used in conjunction with other lipid tests, patient risk assessment and clinical evaluation.
    Device Description
    Quantimetrix is implementing an analysis software capability to the LipoPrint™ System LDL Subfractions. The software application is used in conjunction with commercially available hardware (computer, scanner and color printer) to analyze scanned tube images and generate characterizations of lipoprotein fractions and subfractions resolved by Lipoprint (VLDL, IDL, LDL, HDL).
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