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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: CEC FDA class 2

    Radioimmunoassay, Free Thyroxine

    Clinical Chemistry

    View full classification →

    The Free Thyroxine Radioimmunoassay is a clinical chemistry device that uses radiolabeled antibody techniques to specifically measure free (unbound) thyroxine (free T4) in serum, a more clinically informative measure of thyroid hormone status than total T4, used in diagnosing thyroid dysfunction. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CEC, regulated under 21 CFR 862.1695, within the Clinical Chemistry medical specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Access Free T4
    Elecsys FT4 IV
    MAGLUMI 2000 FT4
    Elecsys FT4 III
    Abbott Architect Free T4
    FREND™ Free T4 Test System
    VIDAS FT4
    DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART
    DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT
    ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET
    ADVIA CENTAUR FT4, ADVIA CENTAUR T4
    LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3
    ABBOTT ARCHITECT FREE T4
    IMMULITE 2000 FREE T4
    ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS
    DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD
    OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104
    DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR
    FASTPACK FREE T4 IMMUNOASSAY
    FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300
    ABBOTT ARCHITECT FREE T4
    FREE T4 MICROWELL EIA, MODEL #7019
    ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
    BIOSTRIDE FREE T4 EIA TEST KIT
    BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS
    SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY
    IMMULITE FREE T4 (2-STEP)
    FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM
    VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15)
    NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT
    ACA PLUS FREE THYROXINE(FT4) METHOD
    ELECSYS FT4 ASSAY
    AMERLITE MAB FT4 ASSAY
    COBAS CORE FREE T3 EIA
    AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK
    OPUS FT4 TEST SYSTEM
    AXSYM FREE THYROXINE ( FREE T4 )
    CIBA CORNING ACS FT3 IMMUNOASSAY
    COBAS(R) CORE FT4 EIA
    FT4 RADIOIMMUNOASSAY
    FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R)
    STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC
    IMMULITE FREE T4
    RADIAS FREE T4 ENZYME IMMUNOASSAY
    BECTON DICKINSON SIMULTRAC COMPONENT SYSTEM
    NAT. SCREENING INSTITUTE MICRO-PLATE FREE T4 ASSAY
    ACCESS(R) FREE T4 ASSAY
    VIDAS FREE THYROXINE(FT4) ASSAY
    VISTA FREE THYROXINE ASSAY
    KODAK AMERLITE MAB FT3 ASSAY

    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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