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510(k) Data Aggregation

    K Number
    K243064
    Device Name
    ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test
    Manufacturer
    Eterbio, Inc.
    Date Cleared
    2024-11-20

    (54 days)

    Product Code
    NGL
    Regulation Number
    862.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Eterbio, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ETERBIO Fentany]Norfentary] Rapid Test (Colloidal Gold) is an immunoassay intended for the qualitative detection of Fentanyl (FTY) /Norfentanyl (NFTY) in human urine: | Drug (Identifier) | Calibrator | Cut-off Level | |--------------------|-------------|---------------| | Fentanyl (FYL) | Fentanyl | 1ng/mL | | Norfentanyl (NFYL) | Norfentanyl | 5ng/mL | The test is available as a single panel for FYL, or as a dual panel combining both FYL and NFYL. It provides a preliminary screening result only. For a confirmed analytical outcome, a more specific chemical is required. GC/MS or LC/MS is the preferred confirmatory method. The ETERBIO Fentanyl Norfentanyl Home Test is an immunoassay intended for the qualitative detection of Fentanyl (FTY) /Norfentanyl (NFTY) in human urine: | Drug (Identifier) | Calibrator | Cut-off Level | |--------------------|-------------|---------------| | Fentanyl (FYL) | Fentanyl | 1ng/mL | | Norfentanyl (NFYL) | Norfentanyl | 5ng/mL | The test is available as a single panel for FYL, or as a dual panel combining both FYL and NFYL. This test provides only preliminary results. For a confirmed analytical outcome, a more specific chemical method is required. GC/MS or LC/MS is the preferred confirmatory method.
    Device Description
    Rapid Test ETERBIO Fentanyl/Norfentanyl Gold) and ETERBIO The Fentanyl/Norfentanyl Home Test are immunoassays intended for the qualitative detection of fentanyl and norfentanyl in human urine. Each ETERBIO fentanyl/norfentanyl urine test device consists of a Test Panel and a package insert. Each Test Panel is sealed with sachets of desiccant in an aluminum pouch.
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