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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: DDG FDA class 2

    Transferrin, Antigen, Antiserum, Control

    Immunology

    View full classification →

    This is an immunological reagent kit for detecting and measuring transferrin, the major iron-binding and iron-transporting protein in human plasma, using antigen, antiserum, and control components for immunoassay-based assessment of iron transport capacity and iron status. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DDG, regulated under 21 CFR 866.5880, within the Immunology specialty.

    510(k) Clearances

    48 matches
    K Number
    Device Name
    Access sTfR
    Transferrin
    Tina-quant Transferrin ver.2 (urine application)
    TRANSFERRIN KIT FOR USE ON THE SPAPLUS
    ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495
    DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA
    TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS
    TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C
    DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H
    DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H
    N ANTISERA TO HUMAN TRANSFERRIN
    VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUCTS PROTEIN
    TINA-QUANT TRANSFERRIN VER.2
    TINA-QUANT TRANSFERRIN VER.2
    MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL
    TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323
    RANDOX TRANSFERRIN
    DIMENSION TRNF FLEX REAGENT CARTRIDGE
    K-ASSAY TRANSFERRIN
    WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR
    N LATEX STFR REAGENT
    TRANSFERRIN SPQ III ANTIBODY REAGENT SET
    TRF
    N ANTISERUM TO HUMAN TRANSFERRIN
    SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT
    N-ASSAY TIA TRANSFERRIN TEST KIT
    IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT
    IMMAGE IMMUNOCHEMISTRY SYSTEM TRANSFERRIN (TRF) REAGENT
    BOEHRINGER MANNHEIM TINA-QUANT TRANSFERRIN ASSAY
    BECKMAN TRANSFERRIN KIT
    IL TEST(TM) TRANSFERRIN (TRF)
    TRANSFERRIN RID KIT
    RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT
    SPQ(TM) ANTIBODY REAGENT SET II FOR TRF
    IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN
    TRANSFERRIN
    QM300 TRANSFERRIN ANTIBODY PACK
    TINA-QUANT [A] TRANSFERRIN
    PRECIMAT(R) TRANSFERRIN
    TDX TRANSFERRIN DIAGNOSTIC KIT
    RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN
    SPQ TEST SYSTEM FOR TRANSFERRIN
    RADIAL IMMUNODIFFUSION PLATES
    NEIA TRANSFERRIN ENZYMEIMMUNOASSAY
    IMMUNOGL. FRCT. OF RABBIT ANTISER.-TRAN
    72 DETERMIN. SIZE RADIAL IMMUNOD. TEST
    J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS
    TRANSFERRIN NEPHELOMETRIC 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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