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510(k) Data Aggregation

    K Number
    K190686
    Device Name
    Optilite IgM CSF Kit
    Manufacturer
    The Binding Site Group Ltd.
    Date Cleared
    2019-05-28

    (71 days)

    Product Code
    CFN
    Regulation Number
    866.5510
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K110035,K120750
    Why did this record match?
    Device Name :

    Optilite IgM CSF Kit

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

    The Optilite IgM CSF Kit is intended for the quantitative in vitro measurement of IgM in cerebrospinal fluid (CSF) samples using the Optilite analyser.

    Device Description

    The Optilite IgM CSF Kit comprises the following reagents:
    Latex Reagent: Supplied in stabilised liquid form. Preservatives: 0.025% sodium azide, 0.1% E-amino-n-caproic acid (EACA) and 0.01% benzamidine, 0.05% ProClin.
    Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, 0.1% EACA and 0.01% benzamidine as preservatives. The concentration given on the quality control certificate has been obtained by comparison with the DA470k international reference material.
    Reaction Buffer: Containing 0.099% sodium azide as a preservative.

    AI/ML Overview

    The provided text describes the 510(k) submission for the Optilite IgM CSF Kit, an in vitro diagnostic device, not an AI/ML-based device. Therefore, the questions related to AI/ML specific criteria, such as expert adjudication, MRMC studies, standalone algorithm performance, and training set details, are not applicable to this submission.

    The acceptance criteria and device performance evaluation for this diagnostic kit are centered on analytical performance characteristics, which are standard for laboratory assays.

    Here's a breakdown of the applicable information from the provided text:

    1. Table of acceptance criteria and the reported device performance:

    Performance CharacteristicAcceptance Criteria (from CLSI Guidelines and Internal Standards)Reported Device Performance
    Precision
    Total Precision (%CV)
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