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510(k) Data Aggregation

    K Number
    K201049
    Device Name
    FINDER G6PD
    Manufacturer
    Baebies, Inc.
    Date Cleared
    2022-09-14

    (876 days)

    Product Code
    JBF
    Regulation Number
    864.7360
    Why did this record match?
    Product Code :

    JBF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FINDER G6PD test is intended for semi-quantitative measurement of glucose-6-phosphate dehydrogenase in venous whole blood specimens collected in lithium heparin tubes, for the identification of G6PD deficient samples. The FINDER G6PD test is intended to be used with the FINDER Instrument in point of care or clinical laboratory settings.
    Device Description
    The FINDER G6PD test system measures G6PD quantitatively from a 50uL venous whole blood specimen. The blood specimen should be collected in lithium heparin anticoagulant. The G6PD test system is suitable for use in both a point-of-care setting and a clinical laboratory. The time to result is around 16 minutes from sample introduction. The FINDER G6PD test system consists of the FINDER G6PD Test Cartridge and the FINDER Instrument. The cartridge uses electrowetting-based digital microfluidics to integrate and automate all the sample and reagent handling steps. The instrument contains all the hardware and software required to operate the cartridge, providing electrowetting control, thermal control and detection capability, a touch-screen user interface and software necessary to perform the test and report results.
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    K Number
    K161364
    Device Name
    BinaxNOW G6PD Test
    Manufacturer
    ALERE SCARBOROUGH, INC.
    Date Cleared
    2016-06-17

    (31 days)

    Product Code
    JBF
    Regulation Number
    864.7360
    Why did this record match?
    Product Code :

    JBF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BinaxNOW® G6PD (Glucose-6-Phosphate Dehydrogenase) Test is an in vitro enzyme chromatographic test for the qualitative detection of G6PD enzyme activity in human venous whole blood, collected in heparin or ethylenediaminetetraacetic acid (EDTA). The BinaxNOW® G6PD Test is a visual screening test used for differentiating normal from deficient G6PD activity levels in whole blood and is intended to aid in the identification of people with G6PD deficiency. Samples which generate deficient results should be assayed using a quantitative G6PD test method to verify the deficiency.
    Device Description
    The BinaxNOW® G6PD test device consists of a lateral flow test strip comprised of a white sample pad and a reaction pad, which is located at the top of the strip. The reaction pad contains the reagents necessary for the G6PD enzymatic reaction and the subsequent reduction of a nitro blue tetrazolium dye into its concomitant blue formazan product. The resulting color change on the strip indicates enough G6PD activity is present to presume the sample is not deficient. To perform the test, a whole blood sample is mixed with red blood cell (RBC) lysing reagent in a sample preparation vial and then transferred to the test device sample pad. The lysed blood sample migrates up the test strip, reconstituting reagents in the reaction pad. When the sample front (or liquid migration) covers the entire reaction pad, the device is closed. Test results are read visually. If no change in the red color of the sample front is observed at the test read time, the sample is presumed to be deficient in G6PD enzyme activity. Samples normal in G6PD activity produce a distinct color change – the red sample color changes to a brown / black color on the upper half of the reaction pad.
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    K Number
    K080003
    Device Name
    BINAXNOW G6PD TEST
    Manufacturer
    BINAX, INC.
    Date Cleared
    2008-10-23

    (295 days)

    Product Code
    JBF
    Regulation Number
    864.7360
    Why did this record match?
    Product Code :

    JBF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BinaxNOW® G6PD (Glucose-6-Phosphate Dehydrogenase) Test is an in vitro enzyme chromatographic test for the qualitative detection of G6PD enzyme activity in human venous whole blood, collected in heparin or ethylenediaminetetraacetic acid (EDTA). The BinaxNOW® G6PD Test is a visual screening test used for differentiating normal from deficient G6PD activity levels in whole blood and is intended to aid in the identification of people with G6PD deficiency. Samples which generate deficient results should be assayed using a quantitative G6PD test method to verify the deficiency.
    Device Description
    The BinaxNOW® G6PD test device consists of a lateral flow test strip comprised of a white sample pad and a reaction pad, which is located at the top of the strip (2 U.S. patents pending). The reaction pad contains the reagents necessary for the G6PD enzymatic reaction and the subsequent reduction of a nitro blue tetrazolium dye into its concomitant blue formazan product. The resulting color change on the strip indicates enough G6PD activity is present to presume the sample is not deficient. To perform the test, a whole blood sample is mixed with red blood cell (RBC) lysing reagent in a sample preparation vial and then transferred to the test device sample pad. The lysed blood sample migrates up the test strip, reconstituting reagents in the reaction pad. When the sample front (or liquid migration) covers the entire reaction pad, the device is closed. Test results are read visually. If no change in the red color of the sample front is observed at the test read time, the sample is presumed to be deficient in G6PD enzyme activity. Samples normal in G6PD activity produce a distinct color change - the red sample color changes to a brown / black color on the upper half of the reaction pad.
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    K Number
    K024006
    Device Name
    G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE
    Manufacturer
    POINTE SCIENTIFIC, INC.
    Date Cleared
    2003-03-31

    (117 days)

    Product Code
    JBF
    Regulation Number
    864.7360
    Why did this record match?
    Product Code :

    JBF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the quantitative determination of glucose-6-phosphate dehydrogenase (G6PD) in blood at 340 nm. For in vitro diagnostic use only.
    Device Description
    Not Found
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