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510(k) Data Aggregation

    K Number
    K990797
    Device Name
    AUTOSTAT II ANTI-SCL-70 ELISA
    Manufacturer
    COGENT DIAGNOTICS LTD.
    Date Cleared
    1999-04-28

    (49 days)

    Product Code
    LLL
    Regulation Number
    866.5100
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but without further information from the provided text, I cannot answer your question. The document is a 510(k) clearance letter from the FDA for a device called "Autostat™ II Anti-Scl-70 ELISA." This letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

    However, the letter does not contain any information regarding:

    • Acceptance criteria or reported device performance for a study.
    • Details of any study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
    • Any mention of AI, multi-reader multi-case studies, or standalone algorithm performance.

    To provide the information you requested, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a marketing submission that details the performance data of the device.

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