LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K201674
    Device Name
    Cultura Collection and Transport System
    Manufacturer
    Merit Medical Systems, Inc
    Date Cleared
    2021-03-03

    (257 days)

    Product Code
    JSM,LIO
    Regulation Number
    866.2390
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    K113249
    Why did this record match?
    Device Name :

    Cultura Collection and Transport System

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

    The Merit Cultura™ Collection and Transport System is intended for collection and transport of clinical specimens to the laboratory for standard diagnostic/identification techniques. The Merit Cultura™ Collection and Transport System is a culture-based media that can be used for upper respiratory viral diagnostic assays including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus.

    Device Description

    The Merit Cultura™ Collection and Transport System contains a sterile nylon-flocked collection swab with a plastic shaft, a vial with 3.0mL of Viral Transport Medium (VTM) and a sealable biohazard bag. Prior to use, vials should be stored at 2-8°C and 23-25°C. After collection, the transport tube containing the specimen can be stored for up to 120 hours at 2-8°C and 23-25°C.

    AI/ML Overview

    The provided text describes the 510(k) premarket notification for the Merit Cultura™ Collection and Transport System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a traditional clinical study with defined acceptance criteria and detailed performance of an AI-powered device.

    Therefore, many of the requested categories for AI device evaluation (such as multi-reader multi-case studies, number of experts, adjudication methods, and sample sizes for test and training sets for an AI algorithm) are not applicable to this submission, as it is for a medical device (a collection and transport system), not an AI/ML algorithm.

    However, I can extract the relevant performance testing data for the physical device based on the provided text.

    Here's the breakdown of the information that is available in the document, structured to best match your request, with an explanation for the non-applicable sections:

    Acceptance Criteria and Device Performance for Merit Cultura™ Collection and Transport System (Non-AI Device)

    The submission demonstrates the ability of the Cultura Collection and Transport System to maintain the viability and detectability of specific viruses over defined periods and temperatures. The acceptance criteria are implicitly defined by the successful recovery and detection of these viruses under testing conditions.

    1. Table of Acceptance Criteria and Reported Device Performance

    Feature/MetricAcceptance CriteriaReported Device Performance
    Culture-Based Studies:Organism Viability: Virus should be viable (present) after specified storage times and temperatures.RSV: Present at T-0 and T-120 hours at 2-8°C and 23-25°C.
    Influenza A Virus: Present at T-0 and T-120 hours at 2-8°C and 23-25°C.
    Influenza B Virus: Present at T-0 and T-120 hours at 2-8°C and 23-25°C.
    Rhinovirus: Present at T-0 and T-120 hours at 2-8°C and 23-25°C.
    Amplification-Based Studies (SARS-CoV-2):Qualitative Concordance: 100% concordance (Ct
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1