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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: LAS FDA class 1

    Drug Specific Control Materials

    Clinical Toxicology

    View full classification →

    Drug-specific control materials are reference materials used in clinical toxicology laboratories to calibrate and validate assay systems that measure drug concentrations in patient specimens. They are classified as FDA Class 1, the lowest risk tier, requiring only general controls such as proper labeling and good manufacturing practices, with no premarket notification required. The product code is LAS, regulated under 21 CFR 862.3280, in the Clinical Toxicology specialty. No special risk flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS
    MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL
    QUANTIMETRIX NICOSURE COTININE URINE CONTROL
    MAS IMMUNOSUPPRESSANT CONTROLS
    DRI OXYCODONE ASSAY
    MICROGENICS CYCLOSPORINE CONTROL KIT
    CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5
    REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE
    INNOFLUOR TOPIRAMATE CONTROL SET
    SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS
    ROCHE-TDM ONLEIN(TM) CONTROLS
    MICROGENICS THC CONTROL SETS
    ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE
    DUPONT ACA URINE METHADONE CONTROL
    REFERENCE MATERIAL FOR PHENCYCLIDINE IN HUMAN URINE
    CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL
    SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR)
    CANNABINOID URINE CONTROLS
    ABUSCREEN ONLINE CANNABINOIDS POSITIVE CONTROL
    ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III
    ABUSCREEN(R) ONLINE(TM) CONTROLS
    ABUSCREEN(R) ONTRAK(R) POSITIVE REF CONT BENZODIAZ
    UTAK LABORATORIES TOXICOLOGY CONTROL
    LYPHOCHEK BENZO/TCA CONTROL SERUM, LEVELS 1 AND 2
    ABUSCREEN(R) ONLINE CONTROLS
    ABUSCREEN POSITIVE REFERENCE CONTROLS
    ABUSCREEN TRI-LEVEL REFERENCE CONTROLS
    ABUSCREEN ONTRAK POS.REF.CONTROL FOR PHENCYCLIDINE
    ABUSCREEN ONTRAK POS. REF. CONTROL FOR COCAINE
    ABUSCREEN ONTRAK POS. REF. CONTROL FOR BARBITUATES
    ABUSCREEN ONTRAK POS. REFERENCE CONTROL FOR THC
    ABUSCREEN ONTRAK POS. REF. CONTROL FOR MORPHINE
    ABUSCREEN ONTRAK POS. REF. CONTROL FOR AMPHETAMINE
    LIQUICHEK(R) SERUM ALCOHOL CONTROL; LEVELS 1,2 & 3
    DU PONT DIMENSION PSEUDOCHOLINESTERASE VERIFIER
    QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2
    DIGOXIN FPIA CONTROLS
    PHENYTOIN FPIA CONTROLS
    CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3
    SERUM VANCOMYCIN TOXICOLOGY CONTROL
    BENZODIAZEPINES TOXICOLOGY CONTROL
    SERUM CLONAZEPAM TOXICOLOGY CONTROL
    HIGH PERFORMANCE CANNABINOID CONTROLS
    EMIT CAFFEINE CONTROL
    EMIT 700 CANNABINOID CONTROL SET
    ACA TRICYCLIC ANTIDEPRESSANTS SCREEN
    MAPROTILINE
    CAFFINE TOXICOLOGY CONTROL
    EMIT SERUM TRICYCLIC ANTIDEPRESS. CONTRO
    PENTOBARBITAL TOXICOLOGY 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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