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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: JXM FDA class 2

    Enzyme Immunoassay, Benzodiazepine

    Clinical Toxicology

    View full classification →

    Enzyme Immunoassay, Benzodiazepine is an in vitro diagnostic test device that uses enzyme immunoassay methodology to detect and quantify benzodiazepine compounds or their metabolites in biological specimens such as urine or serum, used in toxicology screening and therapeutic drug monitoring. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is JXM, regulated under 21 CFR 862.3170, and falls within the Clinical Toxicology medical specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Alinity c Benzodiazepines Reagent Kit
    ONLINE DAT Benzodiazepines II
    CEDIA Benzodiazepine Assay
    DRI Benzodiazepine Assay
    Psychemedics Microplate EIA for Benzodiazepines in Hair
    Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card
    Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
    Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
    Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
    Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
    CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS
    CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD
    RANDOX BENZODIAZEPINE ASSAY
    VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV
    ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000
    SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT
    RANDOX BENZODIAZEPINE CLASS ASSAY
    SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT
    ONLINE DAT BENZODIAZEPINES PLUS
    PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X
    BENZODIAZEPINE ENZYME IMMUNOASSAY
    MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT
    OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I
    BENZODIAZEPINES
    ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICE
    LIVESURE BENZODIAZEPINES SCREEN TESTS
    INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP)
    INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST
    EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229
    BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST
    URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
    SCREENERS BENZODIAZEPINE (BZD) TEST, DRUG SCREEN DIP BENZODIAZEPINE (BZD) TEST
    RAPIDONE- BENZODIAZEPINE TEST
    SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL
    ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)
    ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO
    MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES
    ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES
    AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U
    QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1
    ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST
    QUIKSTRIP ONE STEP BENZODIAZEPINE TEST
    QUIKPAC II ONE STEP BENZODIAZEPINE TEST
    ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B
    CEDIA DAU BENZODIAZEPINE ASSAY
    ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAY
    ACCUSIGN DOA 3/DOA 3 (BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA 3/BZO/BAR/PCP, BIOSIGN BZO/BAR/PCP
    BENZODIAZEPINE SERUM TOX EIA TEST
    CEDIA DAU BENZODIAZEPINE ASSAY(MODIFICATION)
    VISUALINE II BENZODIAZEPINES

    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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