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510(k) Data Aggregation

    K Number
    K252580
    Device Name
    iQ200 Series
    Date Cleared
    2025-09-10

    (26 days)

    Product Code
    Regulation Number
    864.5200
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The iQ200 System is an in-vitro diagnostic device used to automate the complete urinalysis profile, including urine test strip chemistry panel, and microscopic sediment analysis. Optionally, the iQ200 Analyzer can be used as a stand-alone unit, or the results from the iQ200 analyzer can be combined with other urine chemistry results received from an LIS. It produces quantitative or qualitative counts of all formed sediment elements present in urine, including cells, casts, crystals, and organisms. A competent human operator can set criteria for auto-reporting and flagging specimens for review. All instrument analyte image decisions may be reviewed and overridden by a trained technologist.

    Device Description

    The iQ200 Series Automated Urine Microscopy system utilizes a specimen sandwiched between lamina layers presented to a microscope with a CCD video camera. This ensures the specimen is precisely within the microscope's focus and field of view. The system automates sample handling and analyte classification for improved data reporting and management. Specimens are aspirated by an autosampler, and individual particle images are isolated in each frame. The Auto-Particle Recognition (APR) software classifies images into 12 categories, and more, with 27 additional sub-classifications available. Particle concentration is determined by the number of images and the analyzed volume. Results are checked against user-defined criteria and sent for operator review or directly uploaded to the LIS. Specimen results can be edited, imported, and exported.

    AI/ML Overview

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