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    K Number
    K972756
    Device Name
    MODIFICATION OF EST CULTURE SYSTEM II - MYCO
    Manufacturer
    ACCUMED INTL., INC.
    Date Cleared
    1997-08-01

    (63 days)

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

    MODIFICATION OF EST CULTURE SYSTEM II - MYCO

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

    The ESP Culture System II - Myco is an automated system for the growth and detection of -mycobacteria from human specimens, including the use of nucleic acid probes for the direct confirmation of positive ESP - myco bottles.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "ESP™ Culture System II - Myco/modification". This document does not contain the detailed information required to fill out the table and answer all the questions about acceptance criteria and a study proving device performance.

    This type of FDA letter confirms that a device is "substantially equivalent" to a predicate device already on the market, meaning it performs similarly and is as safe and effective. It does not typically include the detailed study methodology, acceptance criteria, or performance data that would be found in a clinical study report or the original 510(k) submission.

    Therefore, I cannot provide the requested information based on the given text. The text mainly focuses on regulatory aspects, such as classification, general controls, and CLIA complexity categorization.

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