BEUDAMED
    Product Code: MOB FDA class 2 21 CFR 866.5660

    Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

    Immunology

    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.

    View on FDA
    510(k)s
    74
    FEI Numbers
    26
    Registration Numbers
    26
    Unique Applicants
    28
    Years Active
    30

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    Basic Information

    Product Code
    MOB
    Device Class
    FDA class 2
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Review Panel
    IM
    Submission Type
    1

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 74 510(k) clearances via K numbers.

    K Number Device Name
    K243776 Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)
    K172582 EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern
    K172461 AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin
    K173792 EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay
    K161258 NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit
    K140225 ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO
    K112545 QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM
    K100917 FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM
    K092601 IMMULISA ANCA SCREEN ELISA
    K092600 IMMULISA PR3 ANTIBODY ELISA
    K092599 IMMULISA MPO ANTIBODY ELISA
    K091859 AESKU PR3
    K091860 AESKULISA MPO, MODEL 30-7303US
    K083850 EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS
    K082130 EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG)
    K070458 MODIFICATION TO FIDIS VASCULITIS, MODEL MX007
    K060700 EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.
    K061376 EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3
    K053012 FIDIS VASCULITIS, MODEL MX007
    K051489 EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM
    K051455 WIESLAB CAP MPO-ANCA
    K051458 WIESLAB CAP PR-3 ANCA
    K050715 QUANTA PLEX ANCA PROFILE
    K041043 VARELISA PR3 ANCA, MODEL NUMBER 17748/17796
    K041040 VARELISA MPO ANCA, MODEL 17648/17696
    K040111 ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM
    K040711 MESACUP TEST PR-3
    K040586 MESACUP TEST MPO, MODEL 11053
    K013285 RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15
    K013283 RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16
    K010287 SCIMEDX PHASE II PR3 IGG ANTIBODY EIA
    K010289 SCIMEDX PHASE II MPO IGG ANTIBODY EIA
    K002215 AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA
    K001127 ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY
    K990796 AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA
    K984516 THE APTUS (AUTOMATED) APPLICATION OF THE MPO ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET
    K984315 THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DE
    K984034 THE APTUS (AUTOMATED) APPLICATION OF THE ANCA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
    K982898 IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM
    K983740 IS-ANTI-PR3 IGG ELISA TEST SYSTEM
    K983390 IS-ANTI-MPO IGG ELISA TEST SYSTEM
    K981750 WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM
    K981748 WIELISA ANCA SCREENING KIT TEST SYSTEM
    K981030 BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT
    K981029 BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT
    K981330 QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT
    K981328 QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT
    K974702 ORGENTEC ANTI-PR3 (C-ANCA) ELISA
    K974701 ORGENTEC ANTI-MPO (P-ANCA) ELISA
    K974167 WIELISA PR-3 ANCA TEST SYSTEM
    K974166 WIELISA MPO ANCA TEST SYSTEM
    K974478 IMMUNO CONCEPTS ANCA TEST SYSTEMS
    K974463 IMMUNO CONCEPTS ANCA TEST SYSTEM
    K973824 VIRGO PANCO KIT
    K973823 PR 3 ANTIBODY KIT
    K973822 VIRGO ANCA SCREEN KIT
    K971690 IMMUNOSCAN PR3-ANCA
    K971689 IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT
    K965133 ANCA COMBI DIAGNOSTIC TEST KIT
    K964449 ANCA SCREEN ELISA TEST SYSTEM
    K964448 PROTEINASE-3 IGG ELISA TEST SYSTEM
    K964446 MYELOPEROXIDASE ELISA TEST SYSTEM
    K962360 IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES
    K961765 MPO ELISA TEST SYSTEM
    K961764 PR-3 ELISA TEST SYSTEM
    K961340 NOVA LITE ANCA
    K955022 QUANTA LITE MPO
    K955021 QUANTA LITE PR3
    K954105 EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES
    K954062 EIA KIT FOR THE DETECTION OF ANTI-MPO ANTIBODIES
    K953587 VARELISA MPO-ANCA
    K953586 VARELISA PR3-ANCA
    K943630 DIASTAT ANTI-MPO (PANCA) KIT
    K942813 DIASTAT ANTI-PR3 (C-ANCA) KIT

    FEI Numbers

    This FDA classification entry is associated with 26 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 26 registration numbers. Click on an entry to view related FDA registrations.