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510(k) Data Aggregation

    K Number
    K252619

    Validate with FDA (Live)

    Device Name
    QSCHECK UISACR
    Manufacturer
    Qstag, Inc.
    Date Cleared
    2026-02-20

    (185 days)

    Product Code
    JFY,JIR,KQO
    Regulation Number
    862.1225
    Type
    Traditional
    Panel
    Clinical Chemistry
    Age Range
    All
    Reference & Predicate Devices
    K182384
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    QSCHECK UISACR is intended for the in vitro semi-quantitative measurement of the following parameters: microalbumin and creatinine in urine specimens and for Albumin/Creatinine ratio (ACR) calculated using those values. The results may be used in conjunction with clinical evaluation as an aid in the assessment for kidney function. The system is intended for prescription use only, in clinical laboratory settings.

    Device Description

    QSCHECK UISACR consists of urine test strips and a smartphone application. In the test strips, the color of the reagent pad that contains enzymes and chemicals is changed according to the concentration of each biomarker in the urine. After the reaction on the strips, the degree of color change is photographed and analyzed by a smartphone application, QSCHECK-app, that runs on both Apple iPhone 14 (iOS v26) and Samsung Galaxy S23 (Android v16).

    The software of the QSCHECK-app. recognizes the location of the reagent pad through the QR code on the urine test strip and checks the degree of color development using RGB color codes. The RGB color codes are converted to Hue (H), Saturation (S), Value (V) color model, which is a method of expressing color or arranging colors according to this method. The results are displayed by matching colorimetric tables for each section that were previously classified according to HSV.

    AI/ML Overview

    N/A

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