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510(k) Data Aggregation

    K Number
    K080085
    Device Name
    MAS TOX CONTROL
    Manufacturer
    Thermo Fisher Scientific
    Date Cleared
    2008-04-30

    (110 days)

    Product Code
    DIF
    Regulation Number
    862.3280
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MAS TOX CONTROL

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

    MAS Tox Control is intended for use as a consistent test sample of known concentration for monitoring assay conditions in the measurement of Benzodiazepines and Barbiturates in human serum and plasma and Tricyclic Antidepressants drugs (TCA) in human serum, plasma and urine.

    Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the MAS Tox Control device. It confirms the device's substantial equivalence to a legally marketed predicate device.

    However, the document DOES NOT contain information about acceptance criteria, device performance metrics, study designs (sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), or training set details for an AI/ML powered device.

    This letter is for a Clinical Toxicology Control Material, which is a quality control product used to monitor the performance of assay conditions for measuring specific substances (Benzodiazepines, Barbiturates, Tricyclic Antidepressants). It is not an AI/ML-powered diagnostic device. Therefore, the requested information categories are not applicable to the content of this document.

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