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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: LDP FDA class 2

    Colorimetry, Acetaminophen

    Clinical Toxicology

    View full classification →

    Colorimetry for acetaminophen measurement is a laboratory method using colorimetric chemical reactions to quantify acetaminophen concentrations in patient specimens, commonly used in clinical toxicology to assess acetaminophen overdose and guide treatment decisions. It is classified as FDA Class 2, requiring 510(k) premarket clearance. The product code is LDP, regulated under 21 CFR 862.3030, in the Clinical Toxicology specialty. Third-party review eligibility applies.

    510(k) Clearances

    36 matches
    K Number
    Device Name
    Acetaminophen
    SEKURE Acetaminophen L3K Assay
    ROCHE ACETAMINOPHEN ASSAY
    ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138
    ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30
    DIMENSION VISTA FLEX REAGENT CARTRIDGES
    TRIAGE TOX DRUG SCREEN
    ACETAMINOPHEN-SL ASSAY
    ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
    ROCHE ACETAMINOPHEN
    SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO
    EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL
    SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT
    COBAS INTEGRA ACETAMINOPHEN
    ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30.
    ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10
    ACETAMINOPHEN FLEX REAGENT CARTRIDGE
    ACETAMINOPHEN SERUM TOX EIA ASSAY
    EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN
    ACETAMINOPHEN ASSAY
    AXSYM ACETAMINOPHEN
    ACETASITE
    SATELLITE A BLOOD ACETAMINOPHEN MONITORING SYSTEM
    ACETAMINOPHEN (ENZYMATIC RATE), NUMBER 502-13
    EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653
    GDS ENZYMATIC ACETAMINOPHEN REAGENT
    ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870
    EMIT QST ACETAMINOPHEN ASSAY
    ACA ACETAMINOPHEN ANALYTICAL TEST PACK
    TDX ACETAMINOPHEN
    ACETAMINOPHER ASSAY KIT
    ACETAMINOPHEN(PARACETAMOL
    PROCEDURE #430 & REAGENTS FOR ACETAMIN
    ACETAMINOPHEN STAT-PAK REAGENT SET
    EMIT-TOX ACETAMINOPHEN ASSAY
    STANBIO ACETAMINOPHEN TEST SET #0850

    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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