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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: DIP FDA class 2

    Enzyme Immunoassay, Diphenylhydantoin

    Clinical Toxicology

    View full classification →

    The Enzyme Immunoassay for Diphenylhydantoin (phenytoin) is a laboratory assay that employs enzyme immunoassay methodology to quantify phenytoin, an anticonvulsant used in the management of epilepsy, in patient serum for therapeutic drug monitoring. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3350 within the Clinical Toxicology specialty. The device qualifies for third-party 510(k) review.

    510(k) Clearances

    44 matches
    K Number
    Device Name
    ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01
    PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS
    ROCHE ONLINE TDM PHENYTOIN
    RANDOX PHENYTOIN
    EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
    IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6
    ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS
    ACE PHENYTOIN REAGENT, AED CALIBRATORS
    CEDIA PHENYTOIN II ASSAY
    IL TEST PHENYTION CALIBRATORS
    PHENYTION EIA TEST
    ACE(TM) CEDIA(R) PHENYTOIN ASSAY
    KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOIN
    PARAMAX(R) PHENYTOIN REAGENT
    BIOTRACK PHENYTOIN TEST CARTRIDGE
    EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORS
    DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD
    CEDIA PHENYTOIN ASSAY
    QMS TM- PHENYTOIN
    IL PHENYTOIN ASSAY SYSTEM
    EZ-BEAD PHENYTOIN ENZYME IMMUNOASSAY KIT
    VISION PHENYTOIN
    EMIT CONVENIENCE PACK: PHENYTOIN ASSAY
    PHENYTOIN FPIA REAGENT SET
    EMDS TM PHENYTOIN (PTN) TESTPACK, ITEM #67676/95
    EASY-TEST PRIMIDONE ITEM NO. 67---/95
    PHENYTOIN, AS PERFORMED ON TECHNICON RA SYSTEMS
    ACCULEVEL PHENYTOIN TEST
    EASY-TEST EMIT PHENYTOIN(PHTN) ITEM # 67535/93
    IL TEST PHENYTOIN
    DETERMINATION OF PHENYTOIN (DIPHENYLHYDANTOIN)
    EMIT QST PHENYTOIN ASSAY -MONOCLONAL ANTIBODY
    SERALYZER ARIS PHENYTOIN REAGENT STRIPS
    EMIT PHENYTOIN ASSAY
    PHENYTOIN ACA ANALYTICAL TEST PACK
    VENTREZYME PHENYTOIN KIT IMMUNOASSAY
    EMIT QST PHENYTOIN ASSAY
    CHEMKIT PHENYTOIN DIAG. KIT
    A-GENT PHERYTOIN
    EMIT AED PHENYTOIN ASSAY
    VIRGO IPA FOR DETECTION OF PHENYTOIN
    ANALYZER, EMIT AED ASSAYS TO CENTRIFICHE
    EMIT ANTIEPILEPTIC DRUG ASSAYS
    PHENYTOIN ANALYTICAL TEST PACKS

    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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