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510(k) Data Aggregation

    K Number
    K982709
    Device Name
    MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY
    Manufacturer
    ALEXON - TREND, INC.
    Date Cleared
    1998-09-03

    (30 days)

    Product Code
    MHJ
    Regulation Number
    866.3220
    Type
    Special
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ProSpecT® Cryptosporidium Microplate Assay uses monoclonal antibodies for the qualitative detection of Cryptosporidium Specific Antigen (CSA) in aqueous extracts of fecal specimens.

    Device Description

    ProSpecT® Cryptosporidium Microplate Assay

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device called "ProSpecT® Cryptosporidium Microplate Assay." It does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria. The letter primarily states the FDA's finding of substantial equivalence to a predicate device.

    Therefore, I cannot extract the requested information about acceptance criteria and study details from this document. The document confirms the device's classification and allows it to be marketed but does not delve into the specifics of performance studies.

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