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510(k) Data Aggregation

    K Number
    K240247
    Device Name
    “MoFi” Cell Culture Basal Medium
    Manufacturer
    DuoGenic StemCells Corporation
    Date Cleared
    2024-07-12

    (164 days)

    Product Code
    NDS
    Regulation Number
    876.5885
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K100616
    Why did this record match?
    Device Name :

    “MoFi” Cell Culture Basal Medium

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

    MoFi is a liquid culture medium intended for human ex vivo tissue and cell culture processing applications.

    Device Description

    MoFi is a basal medium based on Iscove's Modified Dulbecco's Medium (IMDM) and cell-degradabe polysaccharide, made of water, carbohydrate, amino acid and salt. It can be mixed with various serums or additional additives to form a complete medium, which can be used to culture suspension/adherent primary cultured cells or cell lines. MoFi provides cells with energy to maintain survival and promote growth.

    AI/ML Overview

    The provided document describes the FDA 510(k) premarket notification for "MoFi" Cell Culture Basal Medium. This K-submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing details on a study performed by the applicant (DuoGenic StemCells Corporation) to prove performance against specific acceptance criteria for an AI/ML powered device. The document describes a biologically-based product (cell culture medium), not an AI/ML-powered medical device.

    Therefore, the requested information regarding acceptance criteria, AI/ML study design (sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance), and training set details for an AI/ML device cannot be extracted from this document as it does not pertain to such a device.

    The document discusses the following performance characteristics for the MoFi Cell Culture Basal Medium:

    1. Acceptance Criteria and Reported Device Performance (for a cell culture medium, not an AI/ML device):

    Acceptance Criteria (for MoFi Medium)Reported Device Performance (for MoFi Medium)
    Appearance: Transparent yellowish liquidMet (as implied by successful testing)
    pH: 7.0-8.0Met (as implied by successful testing)
    Cell viability: Good cell viabilityGood cell viability of four kinds of cells (suspension primary culture cells, suspension cell lines, adherent primary culture cells, and adherent cell lines)
    Sterility: Negative or not detectedNegative or not detected
    Endotoxin:
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