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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: KLI FDA class 2

    Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

    Clinical Chemistry

    View full classification →

    The Non-Radiolabeled Total Thyroxine Enzyme Immunoassay is an in vitro diagnostic test used in clinical chemistry laboratories to quantitatively measure total thyroxine (T4) concentrations in serum, supporting the assessment of thyroid gland function and the diagnosis or monitoring of thyroid disorders. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket clearance. The product code is KLI and it is regulated under 21 CFR 862.1700 in the Clinical Chemistry specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    VITROS® Automation Solutions
    ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT
    GSP NEONATAL THYROXINE (T4)
    ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL
    ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300
    ACCESS TOTAL T4 ASSAY
    REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105)
    SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS
    BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007
    OPTICOAT T4 EIA KIT
    ABBOTT ARCHITECT TOTAL T4
    ACE T4 REAGENT T4 CALIBRATORS
    ACCUWELL T4-EIA
    TOTAL THROXINE MICROPLATE EIA(225-300)
    DSL ACTIVE T4 EIA
    SYNCHRON SYSTEMS THYROXINE REAGENT
    VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)
    ISOLAB'S T4 TEST KIT
    UBI MAGIWEL THYROXINE (T4) QUANTITATIVE
    BIOCIRCUITS IOS T4/TU TEST CARTRIDGES
    BIOCIRCUITS IOS T4 TEST CARTRIDGE
    RADIAS NEONATAL T4 ENZYME IMMUNOASSAY
    T4 MICROWELL EIA (ENZYME IMMUNOASSAY0
    RADIAS TOTAL T4 ENZYME IMMUNOASSAY
    THYROXINE ENZYME IMMUNOASSAY
    CEDIA T4 MAB ASSAY
    CEDIA T4 MAB ASSAY
    CEDIA T4 MAB ASSAY
    CEDIA T4 MAB ASSAY MODIFICATION
    COBAS (R) CORE T4 EIA
    ACCESS(R) THYROXINE ASSAY
    VIDAS THYROXINE (T4) ASSAY (T4)
    VISTA THYROXINE (T-4) ASSAY -- MODIFICATION
    THYROXINE (FPIA) KIT
    MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT
    CEDIA T4
    TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES
    SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE)
    IMMULITE(TM) TOTAL T4
    IL THYROXINE (T4) ASSAY SYSTEM
    NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR
    OPUS T4 TEST SYSTEM
    THYROXIN(T4) ENZYME IMMUNOASSAY TEST KIT
    AIA-PACK T4
    VITRO T4-EIA-XT
    D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA.
    T4 CLASP-BEAD EIA KIT
    EMIT CONVENIENCE PACK: THYROXINE ASSAY
    THYROXINE MICROASSAY
    ACA THYROXINE (T4 E) METHOD

    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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