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510(k) Data Aggregation

    K Number
    K082086
    Device Name
    KEY RING ALCOHOL BREATHALYZER
    Manufacturer
    THE ASHLEY COLLECTION, INC.
    Date Cleared
    2008-12-19

    (149 days)

    Product Code
    DJZ
    Regulation Number
    862.3050
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    K052448
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
    This devise is intended to measure alcohol in the human breathe. Measurements obtained by this device are use as an aid in the detection of alcohol intoxication.

    Device Description

    Protocol's alcohol breath checker is designed to measure deep lung air to test for the presence of alcohol in the blood. Protocol's breath checker is an alcohol screening device and uses a blow time of at least 3 seconds to capture an accurate deep lung sample. Protocol's alcohol breathe tester contains an oxide semiconductor sensor designed to test for the presence of alcohol. The oxide semiconductor material is heated to a specific temperature. The resistance of sensing material changes rapidly according to gas concentration changes, thereby enabling the reading of alcohol concentration by resistance measurement.. The device provides a semi-quantitative measure of a patient's blood alcohol level using colored LEDs as indicators. The indications are: Red & Yellow: BAC 0.08 or more; Yellow: BAC 0.05 to 0.08; Green: BAC

    AI/ML Overview

    The Protocol Alcohol Breath Checker is a breath-alcohol test system designed to measure alcohol in human breath for the diagnosis of alcohol intoxication.

    Here's an analysis of the acceptance criteria and the study that proves the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document primarily focuses on demonstrating substantial equivalence to a predicate device (K052448, Connectables Pocket Breathalyzer) rather than explicitly stating acceptance criteria with specific numerical targets. However, based on the comparison provided and the ultimate conclusion, we can infer some key performance aspects being "accepted" as equivalent to the predicate.

    FeatureAcceptance Criteria (Inferred from Predicate)Reported Device Performance (Protocol Alcohol Breath Checker)
    Accuracy+/- 0.01% BACSAME (implied to be +/- 0.01% BAC)
    Measurement Range0.00-0.40% BACSAME (0.00-0.40% BAC)
    Blowing Time3 Seconds3 Seconds
    Display InterpretationRed: BAC > 0.08, Yellow: BAC 0.04 to 0.08, Green: BAC
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