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510(k) Data Aggregation

    K Number
    K973203
    Device Name
    THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES
    Manufacturer
    SANGSTAT MEDICAL CORP.
    Date Cleared
    1998-09-30

    (400 days)

    Product Code
    DAK
    Regulation Number
    866.5240
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES

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

    ThymoStat™ is a qualitative plate ELISA for the detection of human anti-rabbit antibodies in human serum. The presence of human anti-rabbit antibodies has been associated with patients receiving injections of rabbit antibodies for therapeutic purposes.

    Device Description

    Not Found

    AI/ML Overview

    This document is primarily a letter from the FDA regarding 510(k) clearance for the ThymoStat™ ELISA device. It confirms FDA approval but does not contain detailed information about acceptance criteria or specific study methodologies, performance data, or ground truth establishment.

    Therefore, I cannot provide the requested information from the given text. The document does not describe:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes for test sets, data provenance, or details about the experts for ground truth.
    • Adjudication methods.
    • Whether MRMC studies were done or effect sizes.
    • Stand-alone performance.
    • The type of ground truth used.
    • Sample size for the training set or how its ground truth was established.
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