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510(k) Data Aggregation

    K Number
    K021163
    Device Name
    OCTEIA 25-HYDROXY VITAMIN D
    Manufacturer
    IMMUNODIAGNOSTIC SYSTEMS LTD.
    Date Cleared
    2002-05-10

    (29 days)

    Product Code
    MRG
    Regulation Number
    862.1825
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    K102432,K110586,K122420,K123364,K123660,K142351
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The IDS OCTEIA® 25-Hydroxy Vitamin D kit is a enzymeimmunoassay intended for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in human serum or plasma to be used in the assessment of vitamin D sufficiency. For In Vitro Diagnostic Use Only.

    Device Description

    enzymeimmunoassay intended for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in human serum or plasma

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "OCTEIA® 25-Hydroxy Vitamin D". It is an in vitro diagnostic device for the quantitative determination of 25-hydroxyvitamin D in human serum or plasma to assess vitamin D sufficiency.

    The letter explicitly states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA did not require new clinical studies to prove effectiveness and safety given its similarity to existing devices. Therefore, the provided document does not contain the information requested in the prompt, such as acceptance criteria, a study that proves the device meets the criteria, sample sizes, ground truth establishment, or expert involvement. These types of details are typically found in the 510(k) submission itself, not the clearance letter.

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

    Summary of missing information:

    • Acceptance criteria and reported device performance: Not specified in the clearance letter.
    • Sample sizes for test set and data provenance: Not specified.
    • Number of experts and qualifications for ground truth: Not specified.
    • Adjudication method: Not specified.
    • MRMC comparative effectiveness study: Not specified, and likely not performed for a "substantially equivalent" determination.
    • Standalone algorithm performance: Not applicable as this is an immunoassay kit, not an AI algorithm.
    • Type of ground truth: Not specified.
    • Sample size for training set: Not applicable based on the substantial equivalence determination.
    • How ground truth for training set was established: Not applicable.
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