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510(k) Data Aggregation

    K Number
    K233417
    Device Name
    AllTest Fentanyl Urine Test Cassette
    Manufacturer
    Hangzhou AllTest Biotech Co.,Ltd
    Date Cleared
    2023-10-26

    (16 days)

    Product Code
    NGL
    Regulation Number
    862.3650
    Type
    Traditional
    Panel
    Toxicology (TX)
    Reference & Predicate Devices
    K231698
    Why did this record match?
    Device Name :

    AllTest Fentanyl Urine Test Cassette

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

    AllTest Fentanyl Urine Test Cassette is is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine at the cutoff concentrations of 1 ng/mL. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

    Device Description

    AllTest Fentanyl Urine Test Cassette is an immunoassay intended for the qualitative detection of fentanyl in human urine. Each AllTest Fentanyl Urine Test Cassette consists of a Test Cassette and a package insert. Each Test Cassette is sealed with sachets of desiccant in an aluminum pouch.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study details for the AllTest Fentanyl Urine Test Cassette, based on the provided FDA 510(k) summary:

    Acceptance Criteria and Reported Device Performance

    The acceptance criteria are implicitly based on the lay user study demonstrating accurate detection of fentanyl at various concentrations relative to the 1 ng/mL cutoff. The reported device performance is indicated by the percentage of correct results from the lay user study, demonstrating high accuracy across different spiked concentrations.

    Acceptance Criteria (Implicit)Reported Device Performance (Lay User Study)
    Ability to correctly identify negative samples at various concentrations below cutoff (e.g., -100%, -75%, -50%, -25% of cutoff)100% correct for -100%, -75%, -50% cutoff samples; 95% correct for -25% cutoff samples.
    Ability to correctly identify positive samples at various concentrations above cutoff (e.g., +25%, +50%, +75% of cutoff)100% correct for +25%, +50%, +75% cutoff samples.
    Ease of understanding package insert instructions by lay users.All lay users indicated instructions were easily followed. Flesch-Kincaid score
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