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510(k) Data Aggregation

    K Number
    K182038
    Device Name
    URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer
    Date Cleared
    2018-12-10

    (133 days)

    Regulation Number
    862.1225
    Why did this record match?
    Applicant Name (Manufacturer) :

    YD Diagnostics Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The URiSCAN 10 ACR urine strips on the URiSCAN Optima urine analyzer are intended for the in vitro qualitative and semi-quantitative measurement of the following parameters: blood, ketones (acetoacetic acid), protein, nitrite, glucose, pH, SG (specific gravity), leucocytes, albumin and the determination of the ACR (albumin creatinine ratio). These measurements are useful in the evaluation of renal, urinary and metabolic disorders. The URiSCAN Optima urine analyzer is intended to read the color change on the test pads found on the URiSCAN 10ACR urine strips and to display and print the results. The URiSCAN 10ACR urine strips include test pads for the following parameters: blood, ketones (acetoacetic acid), protein, nitrite, glucose, pH, SG (specific gravity), leucocytes, albumin and can only be read on the URiSCAN Optima urine analyzer. The URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer are intended for prescription use only, in clinical laboratory and in point-of-care settings.
    Device Description
    The URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer are intended for the in vitro qualitative and semi-quantitative measurement of the following parameters: blood, ketones (acetoacetic acid), protein, nitrite, glucose, pH, SG (specific gravity), leucocytes, albumin and the determination of the ACR (albumin creatinine ratio). The URiSCAN Optima urine analyzer is intended to read the color change on the test pads found on the URiSCAN 10ACR urine strips and to display and print the results. The URiSCAN 10ACR urine strips include test pads for the following parameters: blood, ketones (acetoacetic acid), protein, nitrite, glucose, pH, SG (specific gravity), leucocytes, albumin and can only be read on the URiSCAN Optima urine analyzer.
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    K Number
    K141874
    Device Name
    URISCAN OPTIMA
    Date Cleared
    2015-05-28

    (321 days)

    Product Code
    Regulation Number
    862.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    YD DIAGNOSTICS CORP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The URISCAN Optima urine chemistry test system consists of URiSCAN Optima Urine analyzer and URISCAN 2ACR Urine strips. The intended use of the URiSCAN Optima Urine analyzer is to read the color change on the test pads found on the URiSCAN 2ACR Urine strips and to display and print the results. The intended use of the URiSCAN 2ACR Urine strips is for the in vitro semi quantitative measurement of the following parameters; Albumin Creatinine ACR (Albumin Creatinine Ratio) These measurements are useful in the evaluation of renal, urinary and metabolic disorders. URiSCAN Optima urine chemistry test system is intended for prescription use only, in clinical laboratory and in point-of-care setting.
    Device Description
    URiSCAN Optima - the semi-quantitative urine analyzer is used with the aim of helping examine patients in a professional setting through early detection of disease before they get a thorough checkup, by using chemical components contained in urine; and it is a device to measure the amounts of components in urine, including albumin, creatinine and ACR (albumin creatinine ratio). The results appear on a liquid crystal display and can be printed on the analyzer's internal printer and transferred to a host computer, if desired.
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    K Number
    K060953
    Device Name
    OCCULTECH FECAL OCCULT BLOOD RAPID TEST
    Date Cleared
    2006-09-18

    (165 days)

    Product Code
    Regulation Number
    864.6550
    Why did this record match?
    Applicant Name (Manufacturer) :

    YD DIAGNOSTICS CORP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OcculTech Occult Blood Rapid Test is a card type rapid test and an immunochromatography based in-vitro test designed for qualitative detection of fecal occult blood that can be performed in laboratories or physicians offices. It is useful in determining gastrointestinal bleeding found in a number of gastrointestinal disorders (e.g. diverticulitis, colitis, polyps and colorectal cancer). This device is recommended for use in routine physical examinations, when hospital patients are first admitted, hospital monitoring for bleeding in patients, and screening for colorectal cancer or gastrointestinal bleeding from any source.
    Device Description
    The OcculTech Fecal Occult Blood Rapid Test is a colloidal gold enhanced immunoassay for the detection of hemoglobin in human stool. During the assay the specimen stool are absorbed into the sample pad and migrate upwards chromatographically on the membrane by capillary action. The specimen stool extraction containing hemoglobin forms antibody complex with monoclonal antihemoglobin IgG gold colloid conjugate in the conjugate pad. The mixure migrates to nitrocellulose membrane in the test region where other immobilized monoclonal antihemoglobin IgG is present, and then forms a colored sandwich binding (ant-hemoglobin IgG gold colloid-hemoglobin-anti hemoglobin IgG). The OcculTech Fecal Occult Blood Rapid Test is one step test based on the immunochromatography. The test results are visually determined without using any special instrument. It is a simple operation and a number of specimen can be treated in minimal time.
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    K Number
    K050801
    Device Name
    URISCAN OPTIMA II URINE ANALYZER
    Manufacturer
    Date Cleared
    2005-04-20

    (21 days)

    Regulation Number
    862.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    YD DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UriScan Optima II Urine Analyzer is an automated system for use with UriScan Strip. For routine urinalysis through the analysis of blood, bilirubin, urobilinogen, ketones, protein, nitrite, glucose, pH, specific gravity, and leukocytes, as well as the determination of color.
    Device Description
    Not Found
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    K Number
    K023027
    Device Name
    PREG-Q EARLY PREGNANCY TEST
    Manufacturer
    Date Cleared
    2002-12-16

    (96 days)

    Product Code
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    YD DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Preg-Q hCG Early Pregnancy Test is a rapid visual test for the qualitative detection of hCG in urine to aid in the determination of pregnancy. This test is for over- the-counter, central laboratory, and point of care hospital use.
    Device Description
    The Preg-Q early pregnancy test is a rapid visual test for the qualitative detection of hCG in urine to aid in the determination of pregnancy.
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