BEUDAMED
    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: KLT FDA class 2

    Enzyme Immunoassay, Carbamazepine

    Clinical Toxicology

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    The Carbamazepine Enzyme Immunoassay is an in vitro diagnostic test used in clinical toxicology laboratories to quantitatively measure carbamazepine serum levels, supporting therapeutic drug monitoring for patients receiving this antiepileptic and mood-stabilizing medication. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket clearance. The product code is KLT and it is regulated under 21 CFR 862.3645 in the Clinical Toxicology specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Carbamazepine Gen 4
    ABBOTT CARBAMAZEPINE ASSAY
    ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS
    CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS
    ADVIA IMS CARBAMAZEPINE METHOD
    ONLINE TDM CARBAMAZEPINE
    RANDOX CARBAMAZEPINE
    EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229
    ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM
    IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6
    ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 AND 6E90
    SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL
    VITROS CHEMISTRY PRODUCTS CRBM SLIDES
    ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS
    CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY
    IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS
    CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
    CARBAMAZEPINE FLEX REAGENT CARTRIDGE
    SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM
    CARBAMAZEPINE EIA TEST
    IL TEST CARBAMAZEPINE, PN 181754-00; IL TEST CARBAMAZEPINE CALIBRATORS, PN 181762-00
    AXSYM CARBAMAZEPHINE
    QMS CARBAMAZEPINE ASSAY
    IL TEST CARBAMAZEPHINE
    ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI
    BIOTRACK CARBAMAZEPINE TEST CARTRIDGE
    CEDIA(R) CARBAMAZEPINE ASSAY
    EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS
    ENZYMUN TEST(R) T4 (TOTAL THYROXINE)
    EMIT CONVENIENCE PACK: CARBAMAZEPINE ASSAY
    OPUS CARBAMAZEPINE TEST SYSTEM
    FPR CARBAMAZEPINE KIT
    INNOFLUOR CARBAMAZEPINE REAGENT SET
    EMIT QST CARBAMAZEPINE ASSAY
    CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY
    ACCULEVEL CARBAMAZEPINE TEST
    EMIT CARBAMAZEPINE ASSAY
    SERALYZER ARIS CARBAMAZEPINE STRIPS/MODU/CALI/CONT
    EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95
    EZ-SCREEN: CANNABINOID
    DETERMINATION OF CARBAMAZEPINE
    EMIT QST CARBAMAZEPINE ASSAY
    COBAS FP REAGENTS FOR CARBAMAZEPINE
    CHEMKIT CARBAMAZEPINE DIAGNOSTIC KIT
    EMIT AED CARBAMAZEPINE ASSAY
    AMES TDA DISOPYRAMIDE TEST
    STRATUS CARBAMAZEPINE FLUROMETRIC
    A-GENT CARBAMAZEPINE
    CARBAMEZEPINE REAGENT TEST KIT
    CARBAMAZEPINE FLOURESCENT IMMUNOASSAY

    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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