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510(k) Data Aggregation

    K Number
    K240242
    Device Name
    HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)
    Manufacturer
    Anhui DEEPBLUE Medical Technology Co. LTD.
    Date Cleared
    2024-10-11

    (255 days)

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

    Anhui DEEPBLUE Medical Technology Co. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HCG Home Use Pregnancy Test Strip (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test strip is designed for over-the-counter use. Important note regarding positive results: This test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care. This device is intended for home use only. The HCG Home Use Pregnancy Test Cassette (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test cassette is designed for over-the-counter use. Important note regarding positive results: This test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care. This device is intended for home use only. The HCG Home Use Pregnancy Test Midstream (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test midstream is designed for over-the-counter use. Important note regarding positive results: This test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care. This device is intended for home use only.
    Device Description
    The HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold) and HCG Home Use Pregnancy Test Midstream (Colloidal Gold) utilize a combination of antibodies including a monoclonal HCG antibody to selectively detect elevated levels of HCG. The detection method is to observe the formation of colored lines when testing urine samples with test devices. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-HCG-colored conjugate and form a red colored line at the test line region of the membrane. The absence of this colored line suggests a negative result. To serve as a procedural control, a colored line will always appear in the control line region if the test has been performed properly. HCG Pregnancy Test will be sold in three different formats: Cassette, Strip, and Midstream. The Test Strip and Midstream format contain a test device sealed in a desiccated aluminum pouch and an Instruction. The Cassette format contains a test device, a dropper, a collection container and an Instruction. The test uses two red lines to indicate results. Two distinct red lines appear in the control region (C) and test region (T) means the test is "positive". Only one red line appears in the control region(C). No apparent line in the test region (T). means the test is "negative". If No coloured line appears in the control region (C), or if there is no color band in control region (C) even there is a band in the test region (T),this means "invalid" test result.
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