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510(k) Data Aggregation

    K Number
    K984323
    Device Name
    ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05
    Manufacturer
    BIO-RAD
    Date Cleared
    1998-12-15

    (12 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K950469
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Architect LH MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the LH assay on the Abbott Architect i System.

    Device Description

    Architect LH MasterCheck Level 0 contains HEPES buffer with protein (bovine) stabilizers.

    Architect LH MasterCheck Levels 1, 2, and 3 contain LH (human) prepared in HEPES buffer with protein (bovine) stabilizers.

    Preservative: Antimicrobial Agent.

    AI/ML Overview

    I am sorry, but the provided document does not contain the detailed information required to fill out the table and answer all the questions regarding acceptance criteria and a study proving the device meets them.

    The document is a 510(k) summary for the Bio-Rad Architect LH MasterCheck, which is a control device for an LH assay. It focuses on establishing substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria for the new device.

    Specifically, the document does not include:

    • A table of acceptance criteria for the Architect LH MasterCheck's performance.
    • Reported device performance metrics against specific criteria.
    • Information about sample sizes for test sets, data provenance, number or qualifications of experts for ground truth, or adjudication methods for test sets.
    • Details on a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes related to human reader improvement with AI.
    • Standalone algorithm performance data.
    • The type of ground truth used (beyond implying it's for verifying assay performance, not a diagnostic outcome).
    • Sample size for a training set.
    • How ground truth for a training set was established.

    The content mainly provides:

    • Intended Use: Verification of sensitivity, calibration linearity, and reportable range of the LH assay on the Abbott Architect i System.
    • Device Description: Composition of the control levels.
    • Comparison to Predicate Device: A table comparing characteristics like intended use, form, matrix, storage, analytes, and open vial claim.
    • Regulatory Information: 510(k) clearance letter.

    Therefore, I cannot extract the requested information from this document.

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