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510(k) Data Aggregation

    K Number
    K051321
    Device Name
    INVIEW
    Manufacturer
    METRIKA, INC.
    Date Cleared
    2005-06-13

    (24 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    Why did this record match?
    Applicant Name (Manufacturer) :

    METRIKA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InView™ multi-use test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1c, %A1C) levels in whole blood samples. The test is for home use and professional use for monitoring glycemic control in people with diabetes.
    Device Description
    Not Found
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    K Number
    K033847
    Device Name
    A1CNOW FOR HOME AND PROFESSIONAL USE
    Manufacturer
    METRIKA, INC.
    Date Cleared
    2003-12-23

    (12 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    Why did this record match?
    Applicant Name (Manufacturer) :

    METRIKA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AlcNow® test provides quantitative measurement of glycated hemoglobin (%HbA1c, %A1C) levels in whole blood samples. The test is for home use and professional use for monitoring glycemic control in people with diabetes.
    Device Description
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    K Number
    K022661
    Device Name
    A1CNOW FOR HOME USE
    Manufacturer
    METRIKA, INC.
    Date Cleared
    2002-12-13

    (126 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    Why did this record match?
    Applicant Name (Manufacturer) :

    METRIKA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The A1cNow™ test provides quantitative measurement of the percent of glycated hemoglobin (% HbA1c) levels in fingerstick (capillary) whole blood samples. The test is for home use by people with diabetes to monitor glycemic control.
    Device Description
    AlcNow™ for Home Use is a four-channel reflectance photometer that incorporates microelectronics, optics, and dry-reagent chemistry strips within a self-contained, integrated, single-use device. An unmeasured whole blood mixture (diluted) is applied directly to the sample port, and results are displayed in numeric form on the device's liquid crystal display after eight minutes. Having no switches or buttons, the device self-activates upon addition of the sample. A1cNow™ for Home Use utilizes both immunoassay and chemistry technology to measure HbA1c and total hemoglobin, respectively. Upon the addition of a diluted blood sample, blue microparticles conjugated to anti-HbA1c antibody migrate along the reagent strips. The amount of blue microparticles captured on the strips reflects the amount of HbA1c in the sample. For the total hemoglobin portion of the assay, the dilution of sample converts Hb to met-Hb, which is red-brown in color. The intensity of the red-brown color measured on the reagent strips is proportional to the concentration of hemoglobin in the sample.
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    K Number
    K020234
    Device Name
    A1CNOW FOR RX HOME USE
    Manufacturer
    METRIKA, INC.
    Date Cleared
    2002-02-15

    (23 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    Why did this record match?
    Applicant Name (Manufacturer) :

    METRIKA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AlcNow™ test provides quantitative measurement of the percent of glycated hemoglobin in fresh capillary or venous whole blood samples. The test is for prescription home use by people with diabetes to monitor glycemic control.
    Device Description
    Not Found
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    K Number
    K020235
    Device Name
    A1CNOW FOR PROFESSIONAL USE
    Manufacturer
    METRIKA, INC.
    Date Cleared
    2002-02-15

    (23 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    Why did this record match?
    Applicant Name (Manufacturer) :

    METRIKA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AlcNow™ test provides quantitative measurement of the percent of glycated hemoglobin (% HbA1c) levels in capillary (fingerstick) or venous whole blood samples. The test is for professional use to monitor glycemic control in people with diabetes.
    Device Description
    Not Found
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    K Number
    K000885
    Device Name
    DRX HBA1C - FOR PRESCRIPTION HOME USE
    Manufacturer
    METRIKA, INC.
    Date Cleared
    2000-09-26

    (190 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    Why did this record match?
    Applicant Name (Manufacturer) :

    METRIKA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000887
    Device Name
    DRX HBA1C
    Manufacturer
    METRIKA, INC.
    Date Cleared
    2000-07-26

    (128 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    Why did this record match?
    Applicant Name (Manufacturer) :

    METRIKA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992997
    Device Name
    OSTEOMARK NTX POC
    Manufacturer
    METRIKA, INC.
    Date Cleared
    1999-11-09

    (63 days)

    Product Code
    JMM
    Regulation Number
    862.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    METRIKA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Osteomark NTx Point of Care (POC) is a urinary assay for the quantitative measure of the excretion of cross-linked N-telopeptides of type I collagen (NTx) normalized to urinary creatinine (nM Bone Collagen Equivalents/mM creatinine). The test is used to monitor bone resorption changes following initiation of antiresorptive therapy (e.g., hormone replacement therapy).
    Device Description
    Osteomark NTx Point of Care (POC) is a urinary assay for the quantitative measure of the excretion of cross-linked N-telopeptides of type I collagen (NTx) normalized to urinary creatinine (nM Bone Collagen Equivalents/mM creatinine).
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    K Number
    K991532
    Device Name
    DRX QT. HCG
    Manufacturer
    METRIKA, INC.
    Date Cleared
    1999-09-17

    (137 days)

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

    METRIKA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DRx® Qt. hCG is a rapid, single-use, point-of-care device for the quantitative measurement of human chorionic gonadotropin (total ßhCG) in capillary and venous whole blood samples. The device is for professional use as an aid in the assessment of pregnancy status.
    Device Description
    The DRx® Ot. hCG device is a single-use, disposable four-channel reflectance photometer integrated with dry reagent chemistry strips and contained within a sealed plastic case. Each unit consists of: . an optics subassembly that also supports the reagent strips - a printed circuit board that includes a microprocessor, analog . electronics, battery clips, batteries, silicon diode photodetectors, and j light emitting diodes (LEDs) - a plastic molded part ("spider") that supports the liquid crystal display ● (LCD), the sample pad and the auto start leads, and also provides optical shielding - two reagent strips . - whole blood separation chemistry pad ● - a desiccant - liquid crystal display (LCD) Both test strips are lateral flow immunoassays for measuring hCG between zero and 10,000 mIU/mL. In both strips, a blue color is measured in discrete test zones. The test zones are the areas where the specific reactions occur and concentrations are measured. The whole blood separation mechanism occurs when the whole blood ~ sample reaches the sample pad and immobilizes the red blood cells. As a result, the plasma freely migrates by capillary action onto the assay strips to complete the final reactions. The hCG reaction proceeds as follows: anti-hCG antibody, conjugated to blue microparticles, migrate across the strip upon the addition of whole blood sample. The amount of blue microparticles captured on the test zones is proportional to the amount of hCG in the sample. The LEDs and silicon photodetectors compare the reflectances of the color intensities before and after the sample addition. Based on the calibration parameters stored in memory, the numerical concentrations of hCG is calculated. The final assay results are expressed in mIU/mL hCG.
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    K Number
    K984530
    Device Name
    DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE
    Manufacturer
    METRIKA, INC.
    Date Cleared
    1999-08-10

    (232 days)

    Product Code
    JFY, JMM
    Regulation Number
    862.1225
    Why did this record match?
    Applicant Name (Manufacturer) :

    METRIKA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Osteomark NTx Point of Care (POC) is a urinary assay for the quantitative measure of the excretion of cross-linked N-telopeptides of type I collagen (NTx) normalized to urinary creatinine (nM Bone Collagen Equivalents/mM creatinine). The test is used to monitor bone resorption changes following initiation of antiresorptive therapy (e.g., hormone replacement therapy).
    Device Description
    The Osteomark® NTx POC device is a single-use, disposable four-channel reflectance photometer integrated with dry reagent chemistry strips and contained within a sealed plastic case. Each unit consists of: - an optics subassembly that also supports the reagent strips . - electronics, batteries, photodetectors, and light emitting diodes (LEDs). ● - . plastic parts - two reagent strips ● - a desiccant ● - a liquid crystal display (LCD) ● The reagent strips capillary transport with various chemical reactions. The first strip is an immunoassay for measuring the NTx, and the second strip is a general chemistry assay for measuring the creatinine. In both strips, a blue color is measured in discrete test zones. The test zones are the areas where the specific reaction occurs and concentrations are measured. The NTx reaction proceeds as follows: anti-NTx antibody, conjugated to blue microparticles, migrate across the strip upon the addition of urine sample. The amount of blue microparticles captured on the test zones is proportional to the amount of NTx in the sample. The creatinine reaction proceeds as follows: the addition of the urine sample solubilizes enzymes immobilized in the strip test zones. A cascade of enzymatic reactions mediates the production of hydrogen peroxide from the oxidation of creatinine. In the presence of horseradish peroxidase and a color indicator, a blue color is generated from the hydrogen peroxide with an intensity proportional to the concentration of creatinine in the sample. The LEDs and silicon photodetectors compare the reflectances of the color intensities before and after the sample addition. Based on the calibration parameters stored in memory, the numerical concentrations of NTx and creatinine are calculated. Assay results are expressed in nM Bone Collagen Equivalents (BCE) divided by mM creatinine (nM BCE/mM creatinine).
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