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510(k) Data Aggregation

    K Number
    K022386
    Device Name
    POCKETCHEM UA AUTION STICKS 10TA
    Manufacturer
    ARKRAY, INC.
    Date Cleared
    2002-09-17

    (57 days)

    Product Code
    JIL,JIP,KQO
    Regulation Number
    862.1340
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K960546
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PocketChem™UA is a urine chemistry analyzer and is intended for use with the AUTION Sticks 10TA for the determination of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite and leukocytes in urine. The tests provided by the use of the PocketChem™UA and the AUTION Sticks 10TA are considered routine urinalysis at the following levels of detection:

    AnalyteLevel of Detection
    Glucose50 mg/dL - 1000 mg/dL
    Protein15 mg/dL - 1000 mg/dL
    Bilirubin0.5 mg/dL - Over (>6 mg/dL)
    Urobilinogen2 mg/dL - Over (>8 mg/dL)
    pH5.0 - 9.0
    Specific Gravity1.030
    Blood (Hemolysis and Non Hemolysis)0.06 mg/dL - 1.0 mg/dL
    Ketones5 mg/dL - 150 mg/dL
    NitriteNEG - 2+
    Leukocytes25 Leu/µL - 500 Leu/µL

    For professional use only.

    Device Description

    Automated urine chemistry analyzer - a urinalysis system for the measurement of certain physical properties and chemical constituents of urine.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the ARKRAY PocketChem™UA AUTION Stick 10TA, based on the provided 510(k) submission:

    Acceptance Criteria and Device Performance

    The provided document describes the device's performance in comparison to a predicate device, the Bayer Clinitek 50 / MULTISTIX 10SG Reagent Strips. The acceptance criteria are implicitly defined by the goal of demonstrating substantial equivalence and strong correlation with the predicate device.

    Table of Acceptance Criteria (Implicit) and Reported Device Performance:

    AnalyteAcceptance Criteria (Implicit: strong correlation to predicate)Reported Device Performance
    GlucoseHigh correlation (e.g., >95% agreement) with the predicate device for both negative and positive samples.ARKRAY correlated 97.7% for Glucose with the Bayer System for both negative and positive samples.
    Blood (Hemolysis and Non Hemolysis)High correlation (e.g., >95% agreement) with the predicate device for both negative and positive samples.ARKRAY correlated 100% for Blood with the Bayer System for both negative and positive samples.
    Other analytes (Protein, Bilirubin, Urobilinogen, pH, Specific Gravity, Ketones, Nitrite, Leukocytes)Implicitly, demonstration of comparable performance and reliability to the predicate device would be required. The document states the system detects 10 analytes as per routine urinalysis.While specific percentages for all analytes are not explicitly stated, the document concludes that the "ARKRAY PocketChem™ and AUTION Stick 10TA is substantially equivalent to the Clinitek 50 and MULTISTIX 10SG Reagent Strips manufactured by Bayer Corporation."
    Manual Read PerformanceHigh correlation between manual visual reading of the strips and the automated PocketChem™UA system.The manual read of the AUTION Sticks 10TA compared to the PocketChem™UA System correlated 100% of the samples.
    Reproducibility and PrecisionConsistency of results across repeated measurements and different concentrations.Results confirmed the reproducibility and precision of the ARKRAY PocketChem™UA and AUTION Sticks 10TA throughout the entire range of detection, including extreme negative and positive samples, using control-matrix samples.

    Study Details:

    1. Sample Size used for the test set and the data provenance:

      • Sample Size: Three hundred and two (302) clinical samples were tested for routine urinalysis. Specifically, 30 positive samples were found for glucose and 60 positive for blood within this set.
      • Data Provenance: The document does not explicitly state the country of origin. It describes them as "clinical samples," implying they were collected from patients. It is a retrospective study design since the samples were pre-collected to be tested against the predicate device.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

      • The document does not specify the number of experts or their qualifications for establishing ground truth for the test set. Instead, the "ground truth" for the comparative study was established by the predicate device (Bayer Clinitek 50 & MULTISTIX 10SG).

    3. Adjudication method for the test set:

      • Since the comparison was primarily against a predicate device, and also between the automated system and manual read of the strips, formal expert adjudication of a "ground truth" in the typical sense (e.g., 2+1 radiologist consensus) is not applicable or described. The predicate device's results served as the reference.

    4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

      • No, an MRMC comparative effectiveness study involving human readers improving with AI assistance was not conducted or described. This submission pertains to an automated urine chemistry analyzer, not an AI-assisted diagnostic tool for human interpretation. The closest related test was the comparison between the automated system and a manual read of the strips, but this was to show agreement between two modes of utilizing the same test strip, not human improvement with AI.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

      • Yes, a standalone performance evaluation of the ARKRAY PocketChem™UA system was implicitly done, as its results were directly compared to the predicate device (Bayer Clinitek 50). The system functions as an automated analyzer, meaning it operates without direct human interpretive input beyond sample loading and result verification.

    6. The type of ground truth used:

      • The ground truth for the comparative study was the predicate device's measurements (Bayer Clinitek 50 & MULTISTIX 10SG). For the manual read comparison, the automated system's reading served as a reference to the manual reading of the same strips. For reproducibility and precision, control-matrix samples with known (spiked) concentrations were used.

    7. The sample size for the training set:

      • The document does not provide information regarding a separate training set. Urine chemistry analyzers like the PocketChem™UA often rely on calibrated optical systems and reagent chemistry rather than machine learning models that require distinct "training" datasets in the typical AI sense.

    8. How the ground truth for the training set was established:

      • As no training set is described in the context of machine learning, this question is not applicable. The device's calibration and performance would be established through a manufacturing and quality control process using known standards and control materials.
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