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510(k) Data Aggregation

    K Number
    K180099
    Device Name
    Optilite High Sensitivity C-Reactive Protein Kit
    Manufacturer
    The Binding Site Group Ltd
    Date Cleared
    2018-10-12

    (269 days)

    Product Code
    DCN,SYS
    Regulation Number
    866.5270
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K053603
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    Device Name :

    Optilite High Sensitivity C-Reactive Protein Kit

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

    The Optilite High Sensitivity C-Reactive Protein Kit is intended for the quantitative in vitro measurement of C-Reactive Protein in serum using the Binding Site Optilite analyser for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. This test should be used in conjunction with other laboratory and clinical findings.

    Device Description

    The Optilite High Sensitivity C-Reactive Protein Kit is comprised of latex reagent, single calibrator, controls (high and low) and reaction buffer in liquid form. The reagents contain 0.099% sodium azide as preservative.

    AI/ML Overview

    Acceptance Criteria and Study for Optilite High Sensitivity C-Reactive Protein Kit

    Here's a breakdown of the acceptance criteria and the study results for the Optilite High Sensitivity C-Reactive Protein Kit, based on the provided FDA 510(k) summary:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Performance CharacteristicAcceptance Criteria (Implicit from Study Design)Reported Device Performance (Optilite Kit)
    PrecisionTotal Precision: %CV 3mg/L.
    • Method Comparison with Predicate Device: 391 serum samples (302 reported results within the measuring range). These included 87 normal donors and 304 clinical samples.
    • Expected Values/Reference Range Verification: 50 adult donor samples.

    Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given "The Binding Site Group, Ltd." is based in the UK, it's highly probable that the studies were conducted there. The nature of the studies (e.g., precision, linearity, method comparison) generally implies prospective testing of samples for analytical performance, though the 304 "clinical samples" in the method comparison could be retrospective or a mix.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

    Not applicable. This device is an in vitro diagnostic (IVD) for quantitative measurement of a biomarker (C-Reactive Protein). The "ground truth" for its performance is established through comparisons with reference methods, calibrated materials, and statistical analysis of assay performance (precision, linearity, detection limits), rather than through expert consensus on qualitative interpretation.

    4. Adjudication Method for the Test Set:

    Not applicable, as this is a quantitative IVD device. Test results are numerical and assessed against predefined analytical performance criteria, not subjective interpretations requiring adjudication.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

    No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic imaging devices where human readers interpret images. The Optilite Kit is an automated immunoassay system, not an imaging device requiring human interpretation.

    6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

    Yes, a standalone study of the algorithm (the Optilite High Sensitivity C-Reactive Protein Kit and Optilite analyser) was performed. All the analytical performance characteristics (precision, linearity, detection limits, analytical specificity) and method comparison studies described are standalone evaluations of the device's performance without human intervention in the result generation process.

    7. The Type of Ground Truth Used:

    The ground truth for this device is established through:

    • International Reference Standards: The assay is traceable to the international reference standard ERM-DA474 for calibration.
    • Statistical Definitions: For precision (CV%), linearity (deviation from linearity), detection limits (LoB, LoD, LoQ), established statistical methodologies (CLSI EP5-A3, EP6-A, EP17-A2) define the acceptable "ground truth" or performance targets.
    • Reference Methods/Predicate Device: For method comparison, the results from the legally marketed predicate device (C-Reactive Protein High Sensitive Test System for Cobas Integra Instruments) serve as the comparative "ground truth" for demonstrating substantial equivalence.
    • Clinical Relevance: The reference interval (
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