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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: CDP FDA class 2

    Radioimmunoassay, Total Triiodothyronine

    Clinical Chemistry

    View full classification →

    The Total Triiodothyronine Radioimmunoassay is a clinical chemistry device that uses radioisotope-labeled antibody techniques to measure the total concentration of triiodothyronine (T3) in serum, used in the diagnosis and monitoring of thyroid disorders including hyperthyroidism and hypothyroidism. It is classified as FDA Class 2 (moderate risk), though it is exempt from 510(k) premarket notification. The product code is CDP, regulated under 21 CFR 862.1710, within the Clinical Chemistry medical specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)
    CHIRON DIAGNOSTICS ACS: 180 FT3
    TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005
    AIA-PACK FT3 ASSAY
    OPTICOAT T3 EIA KIT
    ABBOTT ARCHITECT TOTAL T3
    ABBOTT ARCHITECT FREE T3
    AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK
    IMMULITE FREE T3
    ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
    TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA
    DSL ACTIVE T3 EIA
    NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT
    VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020)
    ELECSYS FT3
    ENZYMUN-TEST FT3
    VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010)
    AIA-PACK FT3 ASSAY
    AXSYM FREE TRIIODOTHYRONINE (FREE T3)
    IMX FREE TRIIODOTHYRONINE (FREE T3)
    ELECSYS T3
    FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
    UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE
    ACCESS FREE T3 ASSAY
    T-3 MICROWELL EIA MODEL 7013
    ACTIVE T3 RIA
    TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS
    ACCESS TOTAL T3 ASSAY (MODIFICATION)
    OPUS T3
    IMX T3 ASSAY
    ACCESS(R) TOTAL T3
    AIA-PACK TT3 ASSAY
    AXSYM TOTAL T3
    VIDAS T3 ASSAY
    COBAS(R) CORE T3 EIA
    CIBA CORNING ACS FREE T3 IMMUNOASSAY
    CHEMILUMINESCENCE FREE T3 IMMUNOASSAY
    TRIODOTHYRONINE (TC) COATED TUBE RIA
    MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT
    VISTA TRIIODOTHYRONINE ASSAY
    KODAK AMERLEX MAB FT3 ASSAY
    TECHNICON IMMUNO 1 SYSTEM TOTAL TRIIODOTHYRONINE
    TOTAL T3 CHEMILUMINESCENCE ASSAY
    DOCUMENT CK ISOENZYMES CONTROL
    MILENIA TOTAL T3
    SRI T3 IMMOENZYMETRIC ASSAY
    OPUS T3 TEST SYSTEM
    IMMULITE (TM) TOTAL T3
    FLAGEN TRIIODOTHYRONINE (T3) ASSAY
    IMX FREE TRIIODOTHYRONINE

    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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