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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: KHQ FDA class 2

    Radioassay, Triiodothyronine Uptake

    Clinical Chemistry

    View full classification →

    Triiodothyronine Uptake Radioassay is an in vitro diagnostic test that uses radioisotope methodology to measure the binding of triiodothyronine (T3) to serum proteins, providing an indirect assessment of thyroid hormone binding capacity and free thyroid hormone levels to support evaluation of thyroid function. It is classified as FDA Class 2, indicating moderate risk; devices in this category are subject to general controls and special controls, and typically require 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is KHQ, regulated under 21 CFR 862.1715, within the Clinical Chemistry medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    ACE T UPTAKE REAGENT TU CALIBRATORS
    T-UPTAKE MICROPLATE EIA
    CHIRON DIAGNOSTICS ACS:180TU P
    VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)
    ELECSYS T-UPTAKE ASSAY
    CEDIA T UPTAKE ASSAY
    T-UPTAKE EIA TEST
    STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY
    AXSYM(TM) T-UPTAKE
    VIDAS T UPTAKE
    T3 UPTAKE CHEMILUMINESCENCE ASSAY
    IQ TUPTAKE ASSAY
    COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS
    CIBA CORNING ACS T UPTAKE IMMUNOASSAY
    VISTA THYROXINE UPTAKE ASSAY
    AIA-PACK T-U
    SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE)
    CIBA CORNING ACS T UPTAKE IMMUNOASSAY
    IL T UPTAKE ASSAY SYSTEM
    SEROZYME FREE T3 IMMUNOASSAY
    OPUS TM T-UPTAKE TEST SYSTEM
    T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT
    FIAGEN T3 UPTAKE CATALOGUE #101-402
    EMIT T-UPTAKE ASSAY
    D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN
    VENTREX COATED TUBE T3 UPTAKE
    ACA THYRONINE UPTAKE (TU E) METHOD
    TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE
    T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS
    EMIT CONVENIENCE PACK: T-UPTAKE ASSAY
    EMIT T-UPTAKE ASSAY THYROID HORMONE BINDING RATIO
    AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144
    CEDIA(TM) T UPTAKE
    IMMUBEAD THYROID UPTAKE
    AFFINITY(TM) I UPTAKE IMMUNIT(TM)
    CIBA CORNING MAGIC(R) LITE TU IMMUNOASSAY
    PANCOAT T3 UPTAKE COATED TUBE RADIOIMMUNOASSAY KIT
    FREE T3 RADIOIMMUNOASSAY KIT
    MMS T3 UPTAKE
    STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY
    T3 UPTAKE RADIOIMMUNOASSAY KIT
    T-3 UPTAKE/RIASSAY
    TERUMO SENSIBEAD EIA THYROID UPTAKE KIT
    T3 UPTAKE
    IMMPULSE TBC ASSAY REAGENTS
    TRI-TUBE RIA
    STRATUS THYROID UPTAKE FLUOROMETRIC
    ACA THYROXINE UPTAKE ANALYTICAL TEST
    MAGIC TM 125I T3 UPTAKE RADIOASSAY
    UPTAKE T3 RADIOIMMUNOASSAY 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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