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510(k) Data Aggregation

    K Number
    K972725
    Device Name
    ALCOHOL REAGENT SET
    Manufacturer
    POINTE SCIENTIFIC, INC.
    Date Cleared
    1997-09-25

    (66 days)

    Product Code
    DIC
    Regulation Number
    862.3040
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The alcohol reagent set is for the quantitative determination of ethyl alcohol in serum or whole blood. Alcohol analysis is most frequently requested for emergency room patients to aid in the differential diagnosis of central nervous system depression, which can be due to alcohol intoxication. It is also requested for forensic medicine purposes.

    Device Description

    Alcohol Reagent Set

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for an "Alcohol Reagent Set." It does not contain information about acceptance criteria or a study proving device performance in the way typically seen for AI/ML-driven medical devices.

    The letter indicates that the device is substantially equivalent to a pre-amendment device, which means it likely passed based on performance characteristics similar to those already on the market, rather than a new clinical study with detailed acceptance criteria and performance metrics.

    Therefore, I cannot provide the requested information from the provided text. The document is a regulatory approval notice, not a scientific report detailing a device's performance study.

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