LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K253188
    Device Name
    CoaguChek XS Plus System
    Manufacturer
    Roche Diagnostics
    Date Cleared
    2025-10-24

    (28 days)

    Product Code
    GJS
    Regulation Number
    864.7750
    Type
    Special
    Panel
    Hematology
    Reference & Predicate Devices
    K180684
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CoaguChek XS Plus System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The system uses fresh capillary or non-anticoagulated venous whole blood.

    Device Description

    The CoaguChek XS Plus system is a portable coagulation monitoring system to monitor prothrombin time (PT) in patients receiving oral anticoagulant therapy. The system uses the amperometric detection of thrombin in the blood sample. A test strip is used to determine a PT value from 8 µL of whole blood. Onboard quality control is available on every test strip and the system also features an optional external quality control material (CoaguChek XS PT Control).

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1