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510(k) Data Aggregation

    K Number
    K012907
    Device Name
    LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL
    Manufacturer
    CLINICAL CONTROLS
    Date Cleared
    2001-09-28

    (30 days)

    Product Code
    DIF
    Regulation Number
    862.3280
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K012707
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Clinical Controls LiquiSPx™ Liquid Saliva/Urine Drugs of Abuse Control is a ready-to-use, assayed chemistry control materials for monitoring the accuracy and precision of available analytical procedures. Drug analysis consisting of measuring amphetamine, methamphetamine, phencyclidine, cocaine, tetrahydrocanabinol and morphine is used to assist in the detection and management of drug abuse in at risk patient populations.

    Device Description

    Liquid Saliva/Urine Drugs of Abuse Control

    AI/ML Overview

    I am sorry but this document does not contain the information requested. This document is a 510k clearance letter from the FDA to Clinical Controls for their Liquid Saliva/Urine Drugs of Abuse Control device. It confirms that the device is substantially equivalent to previously marketed devices and can be legally marketed.

    The document does not provide any details about:

    • Acceptance criteria for device performance.
    • The study that proves the device meets acceptance criteria.
    • Sample sizes, data provenance, expert qualifications, or adjudication methods for any studies.
    • Information on MRMC studies, standalone performance, or ground truth types.
    • Details about training sets or how their ground truth was established.

    Therefore, I cannot fulfill your request based on the provided text.

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