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510(k) Data Aggregation

    K Number
    K991432
    Device Name
    BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007
    Manufacturer
    BIOCHECK, INC.
    Date Cleared
    1999-06-02

    (37 days)

    Product Code
    KLI
    Regulation Number
    862.1700
    Type
    Traditional
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007

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

    The BioCheck Total T4 EIA is intended for the quantitative determination of total thyroxine (T4) in human serum. This test is useful in the diagnosis and treatment of thyroid diseases.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the BioCheck Total T4 Enzyme Immunoassay Test Kit. It primarily focuses on the regulatory approval and indications for use. It does not contain the specific details about the acceptance criteria or the study that proves the device meets those criteria, as typically found in a clinical study report or a more detailed technical submission.

    Therefore, I cannot provide the requested information from the given text.

    In general, for a medical device seeking regulatory clearance, a submission would include:

    1. Acceptance Criteria: Predetermined performance thresholds the device must meet (e.g., sensitivity, specificity, accuracy, precision, linearity, stability) compared to a predicate device or a gold standard.
    2. Study Design and Results: Detailed descriptions of the studies conducted to demonstrate that the device meets these criteria. This would typically include:
      • Sample Size: Number of patients or samples used in the study.
      • Data Provenance: Where the data came from (e.g., specific hospitals, geographical regions) and whether it was retrospective or prospective.
      • Ground Truth Establishment: How the true status (e.g., presence or absence of a disease) was determined. For diagnostic tests, this might involve confirmed clinical diagnosis, pathology, or expert consensus.
      • Expert Qualifications: If experts were used, their experience and specialization.
      • Adjudication Method: How disagreements among experts were resolved.
      • MRMC Study: If applicable, to assess reader performance with and without the device.
      • Standalone Performance: The algorithm's performance without human intervention.
      • Training Set Details: Information about the data used to train any AI or algorithm component, including size and ground truth establishment.

    Since this information is not in the provided document, I cannot fill out the requested table or answer the specific questions.

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