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510(k) Data Aggregation

    K Number
    K133741
    Device Name
    ACCU-CHEK Performa Blood Glucose Monitoring System
    Manufacturer
    Roche Diagnostics
    Date Cleared
    2014-08-29

    (263 days)

    Product Code
    NBW
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ACCU-CHEK Performa Blood Glucose Monitoring System

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

    The ACCU-CHEK Performa Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in venous whole blood or fresh capillary whole blood from the fingertips. The ACCU-CHEK Performa Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid in monitoring the effectiveness of glucose control. This system should only be used with single-use, auto-disabling lancing devices.

    The ACCU-CHEK Performa Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. This system is also not for neonatal use.

    The ACCU-CHEK Performa test strips are for use with the ACCU-CHEK Performa meter to quantitatively measure glucose (sugar) in venous whole blood or fresh capillary whole blood samples from the fingertips.

    Device Description

    The ACCU-CHEK Performa blood glucose monitoring system is a blood glucose monitoring system that makes use of the ACCU-CHEK Performa test strips, the ACCU-CHEK Performa meter, the ACCU-CHEK Inform II Control Solutions (cleared under K121679), and the ACCU-CHEK Inform II Linearity Test Kit (cleared under K121679). This system is a multi-patient use blood glucose monitoring system intended to be used in a professional environment to quantitatively measure glucose in venous whole blood and fresh capillary whole blood samples drawn from the fingertips.

    AI/ML Overview

    The ACCU-CHEK Performa Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in venous or fresh capillary whole blood. The system is for in vitro diagnostic use in professional healthcare settings and should only be used with single-use, auto-disabling lancing devices. It is not for the diagnosis or screening of diabetes, nor for neonatal use.

    Here's an analysis of the acceptance criteria and study information provided:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Not explicitly stated as criteria, but inferred from data presentation as performance targets)Reported Device Performance (ACCU-CHEK Performa System)
    Method Comparison (vs. YSI Glucose Analyzer):
    For glucose concentrations
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