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510(k) Data Aggregation

    K Number
    K952220
    Device Name
    MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT
    Manufacturer
    MERETEK DIAGNOSTICS, INC.
    Date Cleared
    1996-09-17

    (495 days)

    Product Code
    LYR
    Regulation Number
    866.3110
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT

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

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called MERETEK UBT™. While it confirms the device's substantial equivalence and outlines regulatory requirements, it does not contain any information regarding the acceptance criteria for a study, nor does it present data from a study that proves the device meets those criteria.

    The letter explicitly states: "Our substantially equivalent determination does not apply to the drug component (NDA 20-586) of your product." It then directs the manufacturer to contact the Center for Drug Evaluation and Research for information on applicable Agency requirements for marketing the drug component. This indicates that the clinical effectiveness and associated studies for the drug component, which is likely central to the device's function, would be handled under a separate NDA process, not detailed here.

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

    The document is solely a regulatory clearance letter and does not include scientific study details such as:

    1. A table of acceptance criteria and the reported device performance: Not present.
    2. Sample size used for the test set and the data provenance: Not present.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
    4. Adjudication method: Not present.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study details: Not present.
    6. Standalone performance study details: Not present.
    7. Type of ground truth used: Not present.
    8. Sample size for the training set: Not present.
    9. How the ground truth for the training set was established: Not present.
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