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510(k) Data Aggregation

    K Number
    K240025
    Device Name
    Clearblue® Early Detection Pregnancy Test
    Manufacturer
    SPD Swiss Precision Diagnostics GmbH
    Date Cleared
    2024-01-31

    (28 days)

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

    SPD Swiss Precision Diagnostics GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Clearblue® Early Detection Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, i.e. as early as five (5) days before the day of the expected period. The test is intended for home use.
    Device Description
    Not Found
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    K Number
    K213379
    Device Name
    Clearblue ® Early Pregnancy Test
    Manufacturer
    SPD Swiss Precision Diagnostics GmbH
    Date Cleared
    2022-09-21

    (343 days)

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

    SPD Swiss Precision Diagnostics GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Clearblue® Early Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, i.e. as early as five (5) days before the day of the expected period. The test is intended for home use.
    Device Description
    The Clearblue® Early Pregnancy Test is an over-the-counter (OTC), visual pregnancy test and is indicated for use up to 6 days before the missed period (5 days before expected period). The device employs an immunochromatographic sandwich assay to detect hCG on a lateral flow test strip. The test incorporates a proprietary, FSH modulated, hCG scavenger system positioned upstream of the hCG test line to maintain high specificity to pregnancy. The scavenger system captures hCG when there are high levels of FSH in the sample. This ensures that hCG is removed from samples with elevated levels of FSH, reducing the chance of false positive results which while rare, may occur in some women. The result is displayed to the user in the test window as two lines for a 'Pregnant' result and one line for a `Not Pregnant' result.
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    K Number
    K210341
    Device Name
    One Step Pregnancy Test
    Manufacturer
    SPD Swiss Precision Diagnostics GmbH
    Date Cleared
    2022-03-10

    (398 days)

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

    SPD Swiss Precision Diagnostics GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    One Step Pregnancy Test is an over-the-counter lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. The visual test is intended for home use as an aid in early detection of pregnancy. The test is indicated for use from 4 days before the day of the expected period (5 days before the day of the missed period).
    Device Description
    The One Step Pregnancy Test is an over-the-counter, visual pregnancy test with sensitivity of 25mIU/mL hCG (human chorionic gonadotropin) and is indicated for use up to 4 days before the expected period (5 days before the missed period). The device eeeploys an immunochromatographic sandwich assay to detect hCG on a lateral flow test strip housed in a cassette. Following sample application using the supplied pipette, the user is required to visually interpret the results displayed as lines in a result window.
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    K Number
    K200913
    Device Name
    Clearblue® Early Digital Pregnancy Test
    Manufacturer
    SPD Swiss Precision Diagnostics GmbH
    Date Cleared
    2021-08-13

    (494 days)

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

    SPD Swiss Precision Diagnostics GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Clearblue® Early Digital Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. This digital test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, i.e. as early as five (5) days before the day of the expected period. The test is intended for home use.
    Device Description
    The Clearblue® Early Digital Pregnancy Test is an over-the-counter (OTC), digital pregnancy test with sensitivity to 10mIU/ml hCG (hormone human chorionic gonadotrophin) and is indicated for use up to 6 days before the missed period (5 days before expected period). The device employs an immunochromatographic sandwich assay to detect hCG on a lateral flow test strip. The result is displayed to the user, in words, on an LCD.
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