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510(k) Data Aggregation

    K Number
    K962841
    Device Name
    OPUS MYOGLOBIN CONTROLS
    Manufacturer
    BEHRING DIAGNOSTICS, INC.
    Date Cleared
    1996-08-15

    (24 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The OPUS Myoglobin Controls are intended for use as quality control material to monitor the precision and accuracy of the OPUS Mvoqlobin assay.

    Device Description

    The OPUS Myoglobin Controls are lyophilized controls containing known levels of human myoglobin in processed human serum. The control is provided at three levels (low, mid and high). The OPUS Myoglobin Control is only for use with the OPUS Myoglobin assay and has not been evaluated for use with other assays.

    AI/ML Overview

    The provided text describes a 510(k) summary for "OPUS Myoglobin Controls," which are quality control materials. It does not describe a study involving a diagnostic device that detects or diagnoses a condition, nor does it present acceptance criteria and performance data in the typical sense of a diagnostic accuracy study.

    Therefore, many of the requested elements (like sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of submission for quality control materials.

    However, I can extract the closest analogous information regarding "acceptance criteria" (implied performance expectations for a QC material) and "device performance" (results of the precision study).

    Here's the breakdown based on the provided text:

    1. A table of acceptance criteria and the reported device performance

    Acceptance Criteria (Implied)Reported Device Performance
    Intra-assay Precision: Not explicitly stated, but generally, acceptable CVs for QC materials in immunoassays are typically low (e.g.,
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