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    K Number
    K962210
    Device Name
    BACTEC 9050 SYSTEM
    Manufacturer
    BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
    Date Cleared
    1996-08-08

    (59 days)

    Product Code
    MDB
    Regulation Number
    866.2560
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BACTEC 9050 SYSTEM

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

    A non-radiometric automated blood culturing system which is designed for the monitoring and detection of clinical cultures of blood for the presence of microorganisms.

    Device Description

    BACTEC® 9050 System is a non-radiometric automated blood culturing system. It has a capacity of 50 specimens, uses Positivity Algorithms by Media Type for culture analysis, has agitation on during testing, uses a Florescence Detector (LED) for detection optics, incubates at 35°C ± 1.5°C, has a protocol length of 4 to 7 Days, uses Florescent Series Media, tests specimens every 10 Minutes, uses Low Voltage DC power supplies, and displays 1 rack (Rotor). Its dimensions are 24"W x 28.5"H x 25.5"D.

    AI/ML Overview

    Here's an analysis of the provided text, focusing on the acceptance criteria and study details:

    Acceptance Criteria and Device Performance

    The provided text focuses on demonstrating substantial equivalence to a predicate device rather than defining specific numerical acceptance criteria for a novel performance threshold. The core acceptance criterion appears to be that the BACTEC 9050 performs "equivalent" to the BACTEC 9240.

    Acceptance CriteriaReported Device Performance (BACTEC 9050 vs. BACTEC 9240)
    Recovery rate of microorganisms for clinically relevant organisms using available media and recommended blood volumes.Difference in recovery: 0.2%
    Mean time to detection of microorganisms.Mean time to detection: Equal (
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