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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: MOB FDA class 2

    Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

    Immunology

    View full classification →

    The Antineutrophil Cytoplasmic Antibodies (ANCA) Test System is an immunological in vitro diagnostic device used to detect ANCA in patient serum, aiding in the diagnosis of vasculitis and related autoimmune conditions such as granulomatosis with polyangiitis. Classified as FDA Class 2 under 21 CFR 866.5660 in the Immunology specialty, it requires 510(k) premarket notification. The product code is MOB, and it is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)
    EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern
    AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin
    EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay
    NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit
    ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO
    QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM
    FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM
    IMMULISA ANCA SCREEN ELISA
    IMMULISA PR3 ANTIBODY ELISA
    IMMULISA MPO ANTIBODY ELISA
    AESKU PR3
    AESKULISA MPO, MODEL 30-7303US
    EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS
    EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG)
    MODIFICATION TO FIDIS VASCULITIS, MODEL MX007
    EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.
    EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3
    FIDIS VASCULITIS, MODEL MX007
    EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM
    WIESLAB CAP MPO-ANCA
    WIESLAB CAP PR-3 ANCA
    QUANTA PLEX ANCA PROFILE
    VARELISA PR3 ANCA, MODEL NUMBER 17748/17796
    VARELISA MPO ANCA, MODEL 17648/17696
    ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM
    MESACUP TEST PR-3
    MESACUP TEST MPO, MODEL 11053
    RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15
    RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16
    SCIMEDX PHASE II PR3 IGG ANTIBODY EIA
    SCIMEDX PHASE II MPO IGG ANTIBODY EIA
    AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA
    ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY
    AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA
    THE APTUS (AUTOMATED) APPLICATION OF THE MPO ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET
    THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DE
    THE APTUS (AUTOMATED) APPLICATION OF THE ANCA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
    IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM
    IS-ANTI-PR3 IGG ELISA TEST SYSTEM
    IS-ANTI-MPO IGG ELISA TEST SYSTEM
    WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM
    WIELISA ANCA SCREENING KIT TEST SYSTEM
    BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT
    BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT
    QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT
    QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT
    ORGENTEC ANTI-MPO (P-ANCA) ELISA
    ORGENTEC ANTI-PR3 (C-ANCA) ELISA
    WIELISA PR-3 ANCA TEST SYSTEM

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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