BEUDAMED
    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: DIS FDA class 2

    Enzyme Immunoassay, Barbiturate

    Clinical Toxicology

    View full classification →

    The Enzyme Immunoassay for Barbiturate is a laboratory test using antibody-based enzyme immunoassay technology to screen for and quantify barbiturate compounds in biological specimens such as urine or serum, supporting emergency toxicology and drug monitoring applications. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3150 within the Clinical Toxicology specialty. This device qualifies for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
    AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup
    Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)
    CR3 Keyless Split Sample Cup Secobarbital- Methadone
    GenPrime Snap-Top Split Key Cup
    ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD
    RANDOX BARITURATES ASSAY
    UCP DRUG SCREENING TEST CUPS
    AT HOME DRUG TEST MODELS, 9308T AND 9308X
    QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SC
    VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS
    ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS
    ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE
    AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II
    ONLINE DAT BARBITURATES PLUS
    RANDOX BARBITURATE ASSAY
    'RAPIDTEC 4' TEST
    BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT)
    PROFILE -ER
    BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT)
    ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE
    VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES
    BARBITURATES
    VISUALINE BARBITURATES DIPSTRIP TEST
    ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE
    LIVESURE BARBITURATES SCREEN TEST
    INSTANT-VIEW BARBITURATE URINE CASSETTE TEST
    INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST
    EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229
    VERDICT -II BAR; VERDICT -II BZO
    VERDICT -II BAR/BZO
    PROFILE-ER
    STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I
    BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TEST
    SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST
    URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A
    RAPIDONE- BARBITURATE TEST
    BIONIKE AQ BARBITURATE TEST
    ROCHE COBAS INTEGRA SERUM BARBITURATES
    MODIFICATION TO ABUSCREEN ONLINE BARBITURATES
    ACCUSIGN BAR, BIOSIGN BAR, STATUS BAR
    ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZO
    ACCUSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP
    ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTD
    AUTO-LYTE BARBITURATES EIA
    QUICK SCREEN BARBITURATE SCREENING TEST MODELS 9020 AND 9021, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODL 9152
    ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE SERUM BARBITURATES CALIBRATORS, ROCHE COBAS IN
    QUICKPAC II ONE STEP BARBITURATE TEST
    QUIKSTRIP ONE STEP BARBITURATE TEST
    ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST

    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.

    Popular Product Codes

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump