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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: DIF FDA class 1

    Drug Mixture Control Materials

    Clinical Toxicology

    View full classification →

    The Drug Mixture Control Materials are reference standards used in clinical toxicology laboratories to verify the accuracy and performance of drug testing assays by providing known concentrations of multiple drug analytes in a single sample. This device is classified as FDA Class 1, indicating low risk, subject only to general controls without premarket notification. It is regulated under 21 CFR 862.3280 within the Clinical Toxicology specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series
    SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ
    MULTICHEM WBT
    DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL
    LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)
    LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK
    THERMO SCIENTIFIC MAS R DOA TOTAL
    LIQUICHEK OPIATE CONTROL
    MAS TOX CONTROL
    CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500
    LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC
    ESA LEADCARE II LEAD CONTROL
    DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516
    TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414
    MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL
    LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK
    LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1)
    TRIAGE TOX DRUG SCREEN CONTROLS
    LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S)
    DC-ACETA/SAL CONTROLS
    LIQUICHEK WHOLE BLOOD VOLATILES CONTROL
    MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT
    LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES)
    LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454; POSITIVE, MODEL 455
    LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES)
    MAS PAR TDM
    LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438; LEVEL S2E, MODEL 439
    LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444
    LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469
    LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS 466 & 467
    LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463
    TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002
    TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001
    LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL
    LIQUICHEK TDM CONTROL
    RANDOX HUMAN ASSSAYED DRUG CONTROL
    URINE DRUG SCREENING CONTROL
    ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544, ONTRAK TESTCUP M2K AND ONTRAK TESTSTICK NEGATIV
    SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1
    ONTRAK TESTCUP AND TESTSTIK CONTROLS
    OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2 AND G3
    VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III
    AC/AD LINEARITY VERIFIERS
    OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3
    LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2, LIQUICHEK URINE TOXICOLOGY CON
    LYPHOCHEK WHOLE BLOOD CONTROL
    IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S
    VIGIL TDM CONTROLS
    PRECINORM TDM CONTROLS
    LYPHOCHEK REMEDI CONTROL

    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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