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510(k) Data Aggregation

    K Number
    K041666
    Device Name
    DC-ACETA/SAL CONTROLS
    Manufacturer
    DIAGNOSTIC CHEMICALS LTD.
    Date Cleared
    2004-08-17

    (60 days)

    Product Code
    DIF
    Regulation Number
    862.3280
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For in vitro diagnostic use in quality control procedures to monitor the accuracy and precision of manual and automated acetaminophe salicylate assays.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA, approving a diagnostic control material. It does not contain the kind of detailed information (acceptance criteria, study design, sample sizes, expert qualifications, etc.) that would typically be found in a clinical study report or a publication describing the validation of a medical AI device.

    Therefore, I cannot provide the requested information. This document is about the regulatory clearance of a quality control material for acetaminophen and salicylate assays, not a device that uses AI or requires extensive performance studies as described in your prompt.

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