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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: LSE FDA class 1

    Epstein-Barr Virus, Other

    Microbiology

    View full classification →

    Epstein-Barr virus (EBV) diagnostic reagents (other types) are in vitro diagnostic products that use various methodologies beyond the standard EBV-specific antibody tests to detect EBV infection or associated conditions in clinical specimens. They are classified as a Class 1 (lowest risk) device, subject only to general controls, representing the least burdensome regulatory category. The product code is LSE, regulated under 21 CFR 866.3235, within the Microbiology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    ADVIA Centaur EBV-VCA IgM
    LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set
    LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set
    SERAQUEST EBV EA-D IGG TEST
    PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G
    BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
    BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
    LIAISON EA IGG
    MODIFICATION TO SERAQUEST EB VCA IGG
    EBV VCA-P18 IGG ELISA
    EBV EA-D IGG ELISA KIT, MODEL EBG-100
    IMMUNOWELL EA (D) IGG TEST
    EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM
    SERAQUEST EB NA IGG
    SERAQUEST EB VCA IGG
    ETI-EA-G ASSAY
    BIOTEST ANTI-EBV RECOMBINANT, EA IGM
    BIOTEST ANTI-EBV RECOMBINANT
    BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG
    COPALIS MULTIPLEX EBV ANTIBODY ASSAY
    EBV-VCA IGG ELISA TEST SYSTEM
    THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO
    THE APTUS (AUTOMATED) APPLICATION OF THE EBV-EA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
    VCA IGM ELISA TEST SYSTEM
    EBNA-1 IGM ELISA TEST SYSTEM
    EA-D IGM ELISA TEST SYSTEM
    IMMUNODOT MONO-G TEST
    IMMUNODOT MONO-M TEST
    ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA
    IMMUNOWELL EBV VCA IGG TEST
    VCA IGG ELISA TEST SYSTEM
    VCA IGM ELISA TEST SYSTEM
    EA-D IGG ELISA TEST SYSTEM
    EBV-VCA IGM ELISA TEST STSTEM
    EBV-EA(D) IGG ELISA TEST
    EBV LGG ELISA TEST
    INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) LGM ELISA KIT
    INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) IGG ELISA KIT
    UNKNOWN
    ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS
    MERIDIAN EBV-EA TEST KIT
    EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA
    BARTELS EPSTEIN-BARR VIRUS IGG EIA
    FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS
    COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS
    EBV/EA-CHECK TM TEST KIT
    EBV-EA IFA KIT
    FIAX EB VCA-M TEST KIT
    EB VCA STAT M TEST KIT
    EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590

    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
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