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510(k) Data Aggregation

    K Number
    K033454
    Device Name
    BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN
    Manufacturer
    BRAHMS DIAGNOSTICA, LLC.
    Date Cleared
    2004-03-22

    (144 days)

    Product Code
    JZO
    Regulation Number
    866.5870
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN

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

    LUMItest TRAK human is a luminescence receptor assay (LRA) for the quantitative determination of antibodies against the human thyrotropin (TSH) receptor. The measurement of TSH receptor autoantibodies is used in the assessment of patients with suspect Graves' disease (autoimmune hyperthyroidism).

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA to BRAHMS Diagnostica, LLC., concerning the device "LUMItest TRAK human". This document primarily focuses on regulatory approval and does not contain the detailed study information required to fully answer your request.

    Specifically, the document states:

    • Device Name: LUMItest TRAK human
    • Regulation Number: 21 CFR 866.5870
    • Regulation Name: Thyroid autoantibody immunological test system
    • Indications for Use: LUMItest TRAK human is a luminescence receptor assay (LRA) for the quantitative determination of antibodies against the human thyrotropin (TSH) receptor. The measurement of TSH receptor autoantibodies is used in the assessment of patients with suspect Graves' disease (autoimmune hyperthyroidism).

    However, it does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for a test set.
    3. Information on experts used to establish ground truth or their qualifications.
    4. Adjudication methods.
    5. Details of a multi-reader multi-case (MRMC) comparative effectiveness study, nor effect sizes.
    6. Results of a standalone algorithm performance study.
    7. The specific type of ground truth used (beyond implying a clinical diagnostic context for "TSH receptor autoantibodies").
    8. The sample size for the training set.
    9. How ground truth for the training set was established.

    Without access to the full 510(k) submission or associated study reports, it's impossible to provide the requested information. The letter merely confirms that the FDA reviewed the submission and found the device substantially equivalent to a legally marketed predicate device.

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