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510(k) Data Aggregation

    K Number
    K252206

    Validate with FDA (Live)

    Date Cleared
    2026-01-09

    (179 days)

    Product Code
    Regulation Number
    862.1225
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K221813

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

    The Nova Allegro urine albumin creatinine ratio (UACR) assay is intended for the quantitative determination of albumin, creatinine, and the albumin/creatinine ratio (UACR) in human urine. The measurement of urine albumin, creatinine, and albumin/creatinine ratio aids in the early diagnosis of nephropathy.

    The Nova Allegro Analyzer is intended for in vitro diagnostic use in clinical laboratory and near-patient testing (point-of-care) settings for the quantitative determination of Nova Allegro Assays using Nova Allegro Test Cartridges.

    Device Description

    Nova Allegro UACR Assay

    The Nova Allegro UACR Assay is a completely automated assay that functions with the Nova Allegro Analyzer for the determination of albumin and creatinine and the calculation of UACR in human urine. The Nova Allegro UACR Assays are performed sequentially using a single Allegro UACR test cartridge. The Allegro UACR Test Cartridge contains all of the reagents for measuring albumin and creatinine. Allegro UACR Controls are used to monitor the performance of the Nova Allegro UACR Test Cartridge and Allegro analyzer.

    Nova Allegro Analyzer

    The Nova Allegro Analyzer is a compact, point-of-care analyzer that features a clinically important menu of measured and calculated tests. All tests are measured with disposable, ready-to-use cartridges. The analyzer supports multiple wavelengths that are used to measure the assay of interest. The analyzer consists of the following key systems/components that the user interacts with:

    • Two analytical bays where the single use test cartridges are analyzed
    • Color Touchscreen Display
    • Barcode Scanner
    • Printer
    • Data Export Options
    • Ethernet Connection
    • USB Port
    AI/ML Overview

    N/A

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