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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: DKB FDA class 2

    Calibrators, Drug Mixture

    Clinical Toxicology

    View full classification →

    The Drug Mixture Calibrators are reference standards containing known concentrations of multiple drug analytes used to calibrate quantitative drug testing instruments and assays in clinical toxicology laboratories. This device is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3200 within the Clinical Toxicology specialty. No special risk flags are associated with this product.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR
    LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS
    ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS
    RANDOX METHAMPHETAMINE ASSAY
    THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS
    ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190
    ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771
    DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510)
    DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420)
    PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
    MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
    VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126
    PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
    DIMENSION DRUG CALIBRATOR II, MODEL DC49C
    PRECISET TDM I AND PRECISET TDM II CALIBRATORS
    PRECISET DAT PLUS I CALIBRATORS
    PRECISET DAT PLUS
    BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS
    RANDOX THERAPEUTIC DRUG CALIBRATOR
    SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS
    EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5
    DIMENSION DRUG CALIBRATOR II, MODEL DC49B
    SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II
    DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS
    SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I
    DRUG CALIBRATOR II
    IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT
    CEDIA DAU MULTI-DRUG CALIBRATORS
    REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE
    EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH)
    SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS
    DRUG CALIBRATOR II
    CEDIA ANTIBIOTIC TDM MULTI-CALS
    AED CALIBRATORS
    SERUM TOX CALIBRATOR
    CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH
    EMIT IIC CALIBRATORS
    DRUGS OF ABUSE CALIBRATOR
    DOA - IMMUNOASSAY CUT-OFF CALIBRATOR
    ROCHE AMMONIA (VARIOUS)
    URINE CALIBRATOR
    CEDIA(R) DAU BAR/BENZ 300,300 INTERMED & HIGH CALIB
    CEDIA DAU NEGATIVE CALIBRATOR
    URINE CALIBRATORS AND CONTROLS MODIFICATION
    CEDIA DAU 4-DRUG CUTOFF CALIBRATOR
    CEDIA DAU 5-DRUG CALIBRATORS
    ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIBRATION PACK
    ABUSCREEN ONLINE(R) CALIBRATORS
    ROCHE ABUSCREEN TRI-LEVEL REFERENCE CONTROLS
    ABUSCREEN CALIBRATION STANDARD

    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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