BEUDAMED
    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: LKJ FDA class 2

    Antinuclear Antibody, Antigen, Control

    Immunology

    View full classification →

    Antinuclear Antibody, Antigen, Control is an antigen and control material used in immunoassay systems designed to detect antinuclear antibodies (ANA), which serve as markers for a range of autoimmune disorders including lupus, Sjogren's syndrome, and mixed connective tissue disease. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LKJ, 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
    EliA Ro52, EliA Ro60
    ANA-SCREEN WITH MDSS
    ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY
    AESKULISA ANA HEP-2, REF 30-7115US
    BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200
    ATHENA MULTI-LYTE ANA-II TEST SYSTEM
    REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001
    AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM
    LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114
    LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113
    LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116
    LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116
    ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)
    MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM
    ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM
    DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM
    LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210
    LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205
    LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212
    LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209
    LIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211
    QUALITROL ANA CONTROL SERUM SET
    HYTEC AUTOIMMUNE KIT (SS-A)
    HYTEC AUTOIMMUNE KITS (SS-B)
    ENZYME IMMUNOASSAY ANA SCREENING TEST KIT
    ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT
    DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT
    SYNELISA CENP-B ANTIBODIES
    SYLNELISA HISTONE ANTIBODIES
    RHEUMELISA II HISTONE ANTIBODY TEST KIT
    SYN ELISA DSDNA ANTIBODIES
    THE THERATEST EL-ANA PROFILES
    AUTOSTAT(TM) ANTI-DSNA
    ENCORE SCL-70
    ANTINUCLEAR ANTIBODY IMMUNOGLOBULIN TEST SYSTEM
    DISTAT ANTI-SCL-70 KIT
    SERATEST ENA [SCL-70] KIT
    QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA
    SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM
    ANA-5 AUTOANTIBODY PROFILE KIT
    ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT)
    ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS)
    ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY
    NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA)
    ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLS
    ANA TEST KIT
    KALLESTAD SM/RNP TEST REAGENT
    SERATEST DNA DETERMINATION
    LEAP LE TEST KIT
    ANA-CHECK

    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

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump