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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: DBF FDA class 2

    Ferritin, Antigen, Antiserum, Control

    Immunology

    View full classification →

    This is an immunological reagent kit for detecting and measuring ferritin, the primary intracellular iron storage protein, in patient serum or plasma for assessment of iron deficiency, iron overload, and inflammatory states. The kit includes antigen, antiserum, and control components for immunoassay use in clinical laboratories. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DBF, regulated under 21 CFR 866.5340, within the Immunology specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    LIAISON Ferritin
    Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor
    Atellica IM Ferritin Assay
    DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET
    K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR
    ADVIA CHEMISTRY FERRITIN (FRT) METHOD
    TINA-QUANT FERRITIN GEN. 4
    BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203
    FERRITIN-LATEX, MODELS 1418-2070, 1418-0279
    RDI HSFERRITIN KIT
    FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H,
    K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET
    QUANTEX FERRITIN
    FERRITIN GENERATION 2
    OLYMPUS FERRITIN REAGENT
    K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET
    RANDOX FERRITIN
    N LATEX FERRITIN
    BIOCHECK FERRITIN ELISA MODEL BC-1025
    CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY
    NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY
    IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR
    ABBOTT ARCHITECT FERRITIN
    BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY
    AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501
    VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)
    MODIFICATION OF OPUS FERRITIN TEST SYSTEM
    SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY
    OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT
    UBI MAGIWEL FERRITIN QUANTITATIVE
    AMERLITE FERRITIN II ASSAY
    N LATEX FERRITIN
    AXSYM FERRITIN
    DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH
    VISTA FERRITIN ASSAY
    AIA-PACK FER CALIBRATION VERIFICATION TEST SET
    VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY
    MODIFIED FERRITIN ENZYME IMUNOASSAY TEST KIT
    SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE)
    CIBA CORNING ACS FERRITIN IMMUNOASSAY
    ELEGANCE FERRITIN ELISA
    LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET.
    MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT
    LAN.0800Q/2800Q
    AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)
    AFFINITY(TM) FERRITIN IMMUNIT(TM)
    FERRITIN SEROZYME IMMUNOENZYMETRIC ASSAY
    MICROMEDIC FERRITIN IRMA KIT
    AMERLITE FERRITIN ASSAY, LAN.0800/1800/2800
    ALLEGRO (TM) FERRITIN IMMUNOASSAY SYSTEM

    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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