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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: CFN FDA class 2

    Method, Nephelometric, Immunoglobulins (G, A, M)

    Immunology

    View full classification →

    The Nephelometric Immunoglobulins (G, A, M) Method is an immunology device that measures IgG, IgA, and IgM concentrations in serum by nephelometry, detecting light scattered by antigen-antibody complexes formed when patient immunoglobulins react with specific antisera, used in the quantitative assessment of humoral immune status and diagnosis of immunodeficiency or gammopathy. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CFN, regulated under 21 CFR 866.5510, within the Immunology medical specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
    Immunoglobulin G (IgG)
    Human IgA liquid reagent kit for Use on SPAPlus
    Optilite IgA Kit
    Optilite IgM Kit
    Human IgM Kit for use on SPAPlus
    Optilite IgM CSF Kit
    Optilite IgA CSF Kit
    DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent
    Optilite IgG4 Kit
    The Optilite IgG3 kit
    BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER
    HUMAN IGA CSF KIT FOR USE ON SPAPLUS
    HUMAN IGG CSF KIT
    HUMAN IGM CSF KIT
    HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT
    HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS
    HUMAN IGA2 KIT FOR USE ON THE SPAPLUS
    HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS
    HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)
    DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID
    N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC
    HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER
    HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS
    DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST
    DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR
    OLYMPUS IGG REAGENT
    OLYMPUS IGA REAGENT
    OLYMPUS IGM REAGENT
    HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER
    DIMENSION VISTA IGM FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H
    DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY
    N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM)
    BINDING SITE IGG SUBLCASS OLYMPUS KITS
    VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS; VITROS CHEMISTRY PRODUCT CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUC
    N LATEX IGM
    HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER
    HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB
    HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T
    HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA
    HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T
    HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER
    BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR
    BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB
    WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
    IGM MININEPH ANTISERUM
    IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS
    HUMAN IGA SUBCLASS BNII COMBI KIT
    COBAS INTEGRA REAGENT CASSETTES
    N-ASSAY TIA IGA

    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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