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510(k) Data Aggregation

    K Number
    K973662
    Device Name
    ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Date Cleared
    1997-12-15

    (81 days)

    Product Code
    LFR,CGA
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    k930979
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Accu-Chek Complete System is intended for testing glucose by persons with diabetes or by health care professionals in the home or in health care facilities.

    Device Description

    The Accu-Chek Complete Meter is an invitro device designed for measuring the concentrations of glucose in whole blood which is applied to Accu-Chek Advantage or Accu-Chek Advantage H Test Strips.

    AI/ML Overview

    The provided 510(k) summary (K973662) for the Accu-Chek Complete Meter does not contain information about acceptance criteria or a study that proves the device meets those criteria.

    This document primarily focuses on establishing substantial equivalence to a predicate device (Accu-Chek Advantage System) by comparing their intended use, operating principles, and various features. It lists similarities and differences between the new device and the predicate but does not present performance data or acceptance criteria for the Accu-Chek Complete Meter itself.

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study results based on the provided text. The document is a 510(k) summary, which often focuses on comparative aspects rather than detailed performance study reports.

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