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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: DLJ FDA class 2

    Calibrators, Drug Specific

    Clinical Toxicology

    View full classification →

    Drug-Specific Calibrators are reference standards used in clinical toxicology laboratories to calibrate analytical instruments and assays measuring specific drugs or drug classes in patient specimens, ensuring result accuracy and traceability. This is a Class 2 device, requiring 510(k) premarket notification before marketing. The product code is DLJ, regulated under 21 CFR 862.3200, within the Clinical Toxicology specialty. No special regulatory flags apply.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2
    QMS LIDOCAINE CALIBRATORS, MODEL 0374678
    DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440
    DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520
    DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)
    DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)
    DIMENSION TACR CALIBRATOR, MODEL DC107
    DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108
    DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108
    LABONE MICRO-PLATE COTININE EIA
    PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS
    PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS
    DRI PRIMIDONE CALIBRATORS
    SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
    CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
    EMIT 2000 VANCOMYCIN CALIBRATORS
    SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
    DRI ECSTASY URINE CALIBRATORS
    CYCLOSPORINE CALIBRATOR
    SYNCHRON SYSTEMS DRUG CALIBRATOR 2
    SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS
    ABUSCREEN ONLINE BENZ 300 CALIBRATORS
    ABUSCREEN ONLINE BENZ 200 CALIBRATORS
    ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
    ACE PHENOBARBITAL REAGENT/AED CALIBRATORS
    50NG/ML COCAINE METABOLITE CALIBRATOR
    CEDIA DIGOXIN CALIBRATORS
    INNOFLOUR CALIBRATOR REAGENT SET
    ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR
    ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20
    STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION
    CEDIA DAU LSD CALBIRATORS
    CEDIA DAU PPX/METH CALIBRATOR
    THEOPHYLLINE CALIBRATORS
    PHENOBARBITAL CALIBRATORS
    PHENYTOIN CALIBRATORS
    CEDIA DAU THC CALIBRATORS
    ABUSCREEN ONLINE LOW-CUTOFF CALIBRATORS
    DUPONT ACA URINE METHADONE CALIBRATOR
    ABUSCREEN ONLINE BENZODIAZEPINES 300 CALIBRATOR
    URINE CALIBRATOR AND CONTROL
    THC URINE CALIBRATORS
    THC URINE CALIBRATORS
    DIGITOXIN FPIA CALIBRATOR SET
    INNOFLUOR(TM) DIGITOXIN CALIBRATOR SET
    ABUSCREEN(R) ONLINE(TM) THC CALIBRATORS
    INNOFLUOR VALPROIC ACID CALIBRATOR SET
    ABUSCREEN ONLINE COCAINE METABOLITE CALIBRATORS
    EMIT(R) II 9 CANNABINOID NEGATIVE CALIBRA/CONTROLS
    DUPONT SALICYLATE CALIBRATOR

    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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