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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: KLS FDA class 2

    Enzyme Immunoassay, Theophylline

    Clinical Toxicology

    View full classification →

    The Theophylline Enzyme Immunoassay is an in vitro diagnostic test used in clinical toxicology laboratories to measure theophylline serum concentrations, supporting therapeutic drug monitoring for patients treated with this bronchodilator to optimize dosing and prevent toxicity. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket notification. The product code is KLS and the applicable regulation is 21 CFR 862.3880 in the Clinical Toxicology specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III
    EMIT CAFFEINE ASSAY
    ROCHE ONLINE THEOPHYLLINE
    RANDOX THEOPHYLLINE
    ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY
    MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229
    ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89
    ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS
    ACCUMETER THEOPHYLLINE TEST
    CEDIA THEOPHYLLINE ASSAY
    IMMULITE THEOPHYLLINE
    THEOPHYLLINE ENZYME IMMUNOASSAY
    IL TEST THEOPHYLLINE
    AXSYM THEOPHYLLINE
    PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS
    VIDAS THEOPHYLLINE(THEO)
    ABBOTT VISION THEOPHYLLINE IIA
    EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS
    IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM
    IL THEOPHYLLINE ASSAY SYSTEM
    TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES
    ENZYMATIC THEOPHYLLINE REAGENT, #500-82
    BIOTRACK THEOPHYLLINE TEST CARTRIDGE
    NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET
    VISION THEOPHYLLINE II
    ACCULEVEL ONE-STEP THEOPHYLLINE TEST
    CEDIA THEOPHYLLINE ASSAY
    COAT-A-COUNT (TM) THEOPHYLLINE
    BEHRING POLAROID OPUS THEOPHYLLINE
    ANALYST THEOPHYLLINE ROTOR
    EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT
    EMIT CONVENIENCE PACK: THEOPHYLLINE ASSAY
    BAKER TDM THEOPHYLLINE ASSAY
    DART THEOPHYLLINE REAGENT SYSTEM
    THEOPHYLLINE FPIA REAGENT SET
    EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95
    METHODS FOR THE DIMENSION CLINICAL CHEM. SYSTEM
    EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93
    VISION THEOPHYLLINE - ADDIT. OF WHOLE BLOOD CLAIM
    EMIT CAFFEINE ASSAY
    KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (THEO)
    MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL
    IN VITRO TEST DETERMINATION OF THEOPHYLLINE
    VISION THEOPHYLLINE
    IL TEST THEOPHYLLINE ASSAY
    GEMSTAR IPA THEOPHYLLINE TEST KIT
    TECHNICON RA-1000 SYSTEM ANALYTE THEOPHYLLINE
    ACCULEVEL THEOPHYLLINE TEST(MODIFICATION)
    ICS THEOPHYLLINE REAGENTS
    ACCULEVEL THEOPHYLLINE TEST

    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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