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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: LLL FDA class 2

    Extractable Antinuclear Antibody, Antigen And Control

    Immunology

    View full classification →

    Extractable Antinuclear Antibody, Antigen and Control is a diagnostic immunoassay system used to detect antibodies against extractable nuclear antigens (ENAs), a group of nuclear proteins associated with specific autoimmune diseases such as Sjogren's syndrome, mixed connective tissue disease, scleroderma, and polymyositis. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LLL, regulated under 21 CFR 866.5100, within the Immunology medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Aptiva CTD Essential Reagent
    EliA SymphonyS Immunoassay
    QUANTA Flash HMGCR Reagents
    QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls
    QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols
    ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA
    QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS
    QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS
    QUANTA FLASH ENA7
    EUROIMMUN ANTI-ENA POOL ELISA (IGG)
    IMMULISA SCI-70 ANTIBODY ELISA
    FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS
    ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01
    FIDIS CONNECTIVE 10, MODEL MX006
    FIDIS CONNECTIVE 8
    ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400
    AESKULISA ENA 6 S
    QUANTA PLEX SLE PROFILE 8
    MESACUP-2 TEST JO-1, MODEL 10756
    AESKULISA ANA 8PRO
    QUANTA PLEX ENA PROFILE 6
    QUANTA PLEX ENA PROFILE 5
    QUANTA PLEX ENA PROFILE 4
    ENA EIA KIT
    ENA EIA KIT RANGE
    ENA SCREEN EIA KIT
    AUTOSTAT II ENA-6 PROFILE ELISA
    AUTOSTAT II ENA-4 PROFILE ELISA
    RHIGENE MESACUP2 TEST- SSB
    RHIGENE MESACUP2 TEST- SCL-70
    RHIGENE MESACUP2 TEST- SSA
    ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST
    ENA PROFILE ELISA TEST SYSTEM
    MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM
    MDI SM TEST
    QUANTA LITE ANA ELISA
    AUTOSTAT II ANTI-SS-B/LA ELISA
    AUTOSTAT II ANTI-JO-1 ELISA
    AUTOSTAT II ANTI-SCL-70 ELISA
    AUTOSTAT II ANTI-SS-A/RO ELISA
    AUTOSTAT II ENA SCREEN ELISA
    LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206
    THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
    THE APTUS (AUTOMATED)APPLICATION OF THE SSB ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET
    THE APTUS (AUTOMATED) APPLICATION OF THE JO-1 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
    THE APTUS (AUTOMATED) APPLICATION OF THE SSA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DC
    THE APTUS (AUTOMATED) APPLICATON OF THE ENA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR S
    QUANTA LITE CHROMATIN ELISA
    EL-ANA PROFILES: EL-ENA/5
    EL-ANA PROFILES: EL-ENA/4

    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.

    Popular Product Codes

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