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510(k) Data Aggregation

    K Number
    K991084
    Device Name
    ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTD
    Manufacturer
    PRINCETON BIOMEDITECH CORP.
    Date Cleared
    1999-04-15

    (20 days)

    Product Code
    DIS,DJR,JXM
    Regulation Number
    862.3150
    Type
    Special
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Immunoassay for the qualitative detection of barbiturates, benzodiazepine, and/or their metabolites in human urine to assist in screening of drug of abuse samples and/or diagnosis of clinical symptoms associated with the use of drugs.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device. It does not contain the detailed study information, acceptance criteria, or performance data that would allow for the completion of the requested table and sections. The letter confirms substantial equivalence to a predicate device but does not present the results of specific performance studies.

    Therefore, I cannot fulfill the request based on the provided input. The document is administrative in nature, granting permission to market the device, rather than a technical report detailing its validation studies.

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