BEUDAMED
    Product Code: PZJ FDA class 2 21 CFR 864.1866

    Lynch Syndrome Test System

    Immunology

    The Lynch Syndrome Test System is an in vitro diagnostic device used to identify loss of DNA mismatch repair proteins or microsatellite instability in tumor tissue from cancer patients, intended to identify patients who may benefit from additional genetic testing for Lynch Syndrome, an inherited cancer predisposition condition. It is classified as a Class 2 device under regulation 864.1866, requiring 510(k) premarket notification, falling within the Immunology (IM) medical specialty with Pathology (PA) review. The product code is PZJ. It is not an implant and is not life-sustaining.

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    510(k)s
    4
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    4
    Years Active
    5

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    Basic Information

    Product Code
    PZJ
    Device Class
    FDA class 2
    Regulation Number
    864.1866
    Medical Specialty
    Immunology
    Review Panel
    PA
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    The Lynch syndrome test system is used to identify loss of DNA mismatch repair proteins or microsatellite instability in tumor tissue from cancer patients for the purpose of identifying patients who may benefit from additional testing for the inherited cancer predisposition Lynch Syndrome

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 4 510(k) clearances via K numbers.

    K Number Device Name
    K211181 Idylla MSI Test
    K213348 BOND MMR Antibody Panel
    K200129 OncoMate MSI Dx Analysis System
    DEN170030 VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.