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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: CDZ FDA class 1

    Radioimmunoassay, Testosterones And Dihydrotestosterone

    Clinical Chemistry

    View full classification →

    The Testosterones and Dihydrotestosterone Radioimmunoassay is a clinical chemistry device that uses radiolabeled immunoassay techniques to measure testosterone and dihydrotestosterone (DHT) concentrations in blood, used in the evaluation of androgen excess or deficiency, hypogonadism, and related endocrine disorders. It is classified as FDA Class 1 (lowest risk). The product code is CDZ, regulated under 21 CFR 862.1680, within the Clinical Chemistry medical specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    IDS-iSYS Free Testosterone
    Access SHBG
    Access Testosterone
    Elecsys Testosterone II
    LIAISON Testosterone xt
    ACTIVE® Free Testosterone RIA
    ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG
    IDS SHBG
    FastPack IP Sex Hormone Binding Globulin Immunoassay
    Free Testosterone AccuBind ELISA Test System
    FREND Testosterone Test System
    ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material
    Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator
    ARCHITECT SHBG
    ARCHITECT 2nd Generation Testosterone
    ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set
    ADVIA CENTAUR TESTOSTERONE (TSTO)
    LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET
    TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED)
    FASTPACK TESTO IMMUNOASSAY
    ELECYSYS SHBG
    ELECSYS TESTOSTERONE II IMMUNOASSAY
    ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773
    ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND
    ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01
    DRG SLV TESTOSTERONE ELISA TEST
    ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA)
    IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE
    FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT
    ELECSYS SHBG IMMUNOASSAY
    ST AIA-PACK TESTOSTERONE ASSAY
    FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY
    VIDAS TESTOSTERONE (TES), MODEL 30 418
    TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA)
    BIOCHECK TESTOSTERONE EIA, MODEL BC-1115
    ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565
    FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900
    DRG AURICA ELISA TESTOSTERONE KIT
    ABBOTT ARCHITECT TESTOSTERONE
    TESTOTERONE ELISA
    ACTIVE TESTOSTERONE EIA (DSL-10-4000)
    ELECSYS TESTOSTERONE ASSAY
    TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
    BIODATA TESTOSTERONE MAIA KIT
    IMMULITE TOTAL TESTOSTERONE
    IMMULITE SHBG (MODIFICATION)
    AURAFLEX TESTOSTERONE CALIBRATOR PACK
    ACTIVE FREE TESTOSTERONE RIA
    IMMULITE SHBG
    DELFIA SHBG KIT

    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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