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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: DFH FDA class 2

    Kappa, Antigen, Antiserum, Control

    Immunology

    View full classification →

    The Kappa Antigen, Antiserum, and Control is an immunological reagent used in clinical laboratories to detect and measure kappa light chains, which are components of immunoglobulin molecules. This product falls under FDA Class 2, indicating it is a moderate-risk device subject to general controls and special controls, and manufacturers must submit a 510(k) premarket notification before marketing. It is regulated under 21 CFR 866.5550 and classified within the Immunology medical specialty. This device is eligible for third-party 510(k) review, allowing an FDA-recognized accredited organization to conduct the initial review in place of FDA.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit
    FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2
    Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
    FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2
    Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
    Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
    N Latex FLC kappa, N Latex FLC lambda
    N Latex FLC kappa, N Latex FLC lambda
    N Latex FLC kappa, N Latex FLC lambda
    N Latex FLC kappa, N Latex FLC lambda
    N Latex FLC kappa assay, N Latex FLC lambda assay
    Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit
    Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay
    N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2
    Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator
    Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit
    HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER
    KAPPA LIGHT CHAINS
    DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL
    FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT
    FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER
    FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER
    CAPILLARY'S IMMUNOTYPING (PN 2100)
    FREELITE HUMAN KAPPA AND LAMBDA KITS
    FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER
    KAPPA IMMAGE FREELITE KIT
    SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT
    IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAG
    CHEMMATE(TM) UCHL1 (CD45-RO)
    CHEMMATE(TM) KAPPA
    BECKMAN KAPPA LIGHT CHAIN REAGENT (ADD'L CLAIMS)
    BECKMAN LAMBDA LIGHT CHAIN REAGENT
    BECKMAN KAPPA LIGHT CHAIN REAGENT
    N-IMMUNOGLOBULIN LIGHT CHAIN KIT
    QM300 KAPPA LIGHT CHAINS ANTIBODY PACK
    QUANTIMETRIC PLUS KAPPA REAGENT KIT
    TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM
    AMER. HISTO-ID SYS PRIMARY KIT
    FITC GOAT ANTI-HUMAN KAPPA AFFINITY
    GOAT ANTI-HUMAN IMMUNOGLOBULINS-
    FITC ANTISERA TO HUMAN LAMBDA
    FITC ANTISERA TO HUMAN GOBULIN
    FITC ANTISERA TO HUMAN IGA
    ANTISERUM TO HUMAN KAPPA
    ANTISERUM TO HUMAN IGM
    FITC ANTISERA TO HUMAN C3
    ANTISERUM TO HUMAN IGA
    FITC ANTISERA TO HUMAN KAPPA
    ANTISERUM TO HUMAN LAMBDA
    FITC ANTISERA TO HUMAN IGM

    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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