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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: DJG FDA class 2

    Enzyme Immunoassay, Opiates

    Clinical Toxicology

    View full classification →

    The Enzyme Immunoassay for Opiates is a laboratory test using antibody-based enzyme immunoassay technology to screen for the presence of opiates in biological specimens, commonly employed in workplace drug testing, clinical toxicology, and emergency screening panels. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3650 within the Clinical Toxicology specialty. The device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    LZI Fentanyl III Enzyme Immunoassay
    BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader
    Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard
    Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard
    Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card
    LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)
    Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test
    Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup
    ARK Hydrocodone Assay
    Evidence MultiSTAT DOA Urine MultiPlex
    Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT
    CEDIA Heroin Metabolite (6-AM) Assay
    AllTest Fentanyl Rapid Test (Urine)
    Emit® II Plus Buprenorphine Assay
    BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx
    Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
    Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11
    Immunalysis Tapentadol Urine HEIA
    SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay
    AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
    Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair
    ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
    LZI Oxycodone III Enzyme Immunoassay
    LZI Fentanyl II Enzyme Immunoassay
    LZI Tramadol Enzyme Immunoassay
    ARK Fentanyl II Assay
    CEDIA Heroin Metabolite (6-AM) assay
    Psychemedics Microplate EIA for Fentanyl in Hair
    ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
    ARK Tramadol Assay
    LZI Fentanyl Enzyme Immunoassay
    ARK Fentanyl Assay
    Synermed Opiate Enzyme Immunoassay
    DRI Hydrocodone Assay
    CEDIA Heroin Metabolite (6-AM) Assay
    Emit II Plus Oxycodone Assay
    Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators
    CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set
    Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard
    Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests
    First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Buprenorphine Dip Card Test, First Sign® Drug of Abuse Butalbital Cup Test, First Sign® Drug of Abuse Butalbital Dip Card Test, First Sign® Drug of Abuse Morphine Cup Test, First Sign® Drug of Abuse Morphine Dip Card Test.
    Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive
    DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls
    Wondfo CR3 Keyless Split Sample Cup
    Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls
    Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000
    Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls
    CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids
    LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6
    IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY

    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