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510(k) Data Aggregation

    K Number
    K984324
    Device Name
    ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05
    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 Prolactin MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Prolactin assay on the Abbott Architect i System.

    Device Description

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

    Architect Prolactin MasterCheck Levels 1, 2, 3 and 4 contain prolactin (human) prepared in HEPES buffer with protein (bovine) stabilizers.

    Preservative: Antimicrobial Agent.

    AI/ML Overview

    The provided text is a 510(k) summary for the Bio-Rad Architect Prolactin MasterCheck, a medical device intended for calibrating and verifying the performance of the Abbott Architect i System's Prolactin assay. The document does not contain details about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, adjudication methods, or comparative effectiveness studies in the context of an AI device.

    It solely focuses on:

    • Device Description: Composition and intended use of the Architect Prolactin MasterCheck.
    • Substantial Equivalence Claim: Comparison to a predicate device (Casco Standards Document Serum Multi-Analyte Verification Test Set) based on intended use, form, matrix, storage, analytes, and open vial claim.
    • FDA 510(k) Clearance: The letter from the FDA granting clearance for marketing.

    Therefore, I cannot provide the requested information as it is not present in the given document.

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