LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K041578
    Device Name
    QUICKSCREEN, MODELS 9177X AND 9178X
    Manufacturer
    PHAMATECH
    Date Cleared
    2004-09-10

    (88 days)

    Product Code
    LCM,DIO,DJC,DJG,DKZ,LDJ
    Regulation Number
    N/A
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    QUICKSCREEN, MODELS 9177X AND 9178X

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

    An in vitro diagnostic test for the qualitative identification of amphetamine, cocaine, opiates, PCP and THC in urine. The measurements obtained by this device are used in the diagnosis of drug abuse. It is intended for professional use only.

    An in vitro diagnostic test for the qualitative identification of amphetamine, cocaine, opiates, methamphetamines and THC in urine. Measurements obtained by this device are used in the diagnosis of drug abuse. It is intended for professional use only.

    Device Description

    Immunoassay for the qualitative detection, Amphetamine, THC, Cocaine, Opiates and PCP (9177X) or Methamphetamines (9178X) in urine.

    The Phamatech QuickScreen™ Model 9177X & 9178X, like many commercially available drug screening test kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoassay technology.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and study detailed in the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are not explicitly stated as distinct numerical targets (e.g., "sensitivity must be >90%"). Instead, the document frames acceptance in terms of "substantial equivalence" to existing commercially available tests and a "correlation" threshold.

    Acceptance Criteria (Implied)Reported Device Performance
    Substantial equivalence to commercially available drug screening tests for qualitative detection of target drugs in urine.Phamatech QuickScreen™ Models 9177X & 9178X were found to be substantially equivalent to the reported performance characteristics of other commercially available tests.
    High correlation with existing tests when used by professional users.Correlation studies produced a >98% correlation when compared to the QuickScreen™ in the hands of professional users.

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size: The document does not specify the exact sample size for the clinical sample correlation studies. It only states "clinical specimens."
    • Data Provenance: The data provenance is not explicitly stated (e.g., country of origin). The studies are described as "clinical sample correlation," implying real-world samples but not detailing their collection context. The studies appear to be retrospective as they are measuring correlation against existing, commercially available tests.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

    The document does not specify the number of experts used or their qualifications. The "ground truth" seems to be established by comparison to "other commercially available tests" and their "reported performance characteristics." The study then evaluated the QuickScreen™ "in the hands of professional users," but these professional users are not explicitly stated to be the ground truth setters, rather the evaluators of the device.

    4. Adjudication Method for the Test Set

    The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The evaluation is described as "correlation studies, using clinical specimens, produced a >98% correlation when compared to the QuickScreen™ in the hands of professional users." This suggests a direct comparison to results from predicate devices, rather than an expert consensus process for establishing ground truth for individual cases.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focuses on the standalone performance and correlation of the device itself rather than its effect on human reader performance.

    6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

    Yes, a standalone performance evaluation was done. The "product performance characteristics" were evaluated in "clinical sample correlation" studies, comparing the Phamatech QuickScreen™ Models 9177X & 9178X against "other commercially available tests." While professional users handled the QuickScreen™, the core evaluation is on the device's ability to qualitatively detect drugs, which is a standalone function.

    7. The Type of Ground Truth Used

    The ground truth used was based on the reported performance characteristics of other commercially available drug screening tests. This implies that these predicate devices themselves served as the reference for determining whether the Phamatech QuickScreen™ was correct in its qualitative detection.

    8. The Sample Size for the Training Set

    The document does not mention a training set or its sample size. This device is an immunoassay, not an AI/ML algorithm that typically requires a training set.

    9. How the Ground Truth for the Training Set Was Established

    Not applicable, as there is no mention of a training set for this immunoassay device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1