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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: LCM FDA unclassified

    Enzyme Immunoassay, Phencyclidine

    Unknown

    View full classification →

    Enzyme immunoassay for phencyclidine (PCP) is a laboratory immunoassay test used to detect phencyclidine, a dissociative drug, in patient specimens for clinical toxicology screening or confirmation purposes. This device is currently unclassified by the FDA, with no assigned regulation number or medical specialty designation, meaning its regulatory requirements have not been definitively established. The product code is LCM. No special risk flags apply.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair
    SEFRIA PCP Oral Fluid Enzyme Immunoassay
    Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay
    Atellica CH Phencyclidine (Pcp)
    Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
    CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE
    OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE
    RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR
    PSYCHEMEDICS PHENCYCLIDINE EIA
    THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY
    ORAL FLUID PHENCYCLIDINE
    OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE
    RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054
    VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V
    ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000
    QUEST DIAGNOSTICS HAIRCHECK-DT (PCP
    RANDOX PHENCYCLIDINE ASSAY
    ONLINE DAT PHENCYCLIDINE PLUS
    QUICKSCREEN, MODELS 9177X AND 9178X
    AMEDICA DRUG SCREEN PHENCYCLIDINE TEST
    PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011
    PHENCYCLIDINE
    AMEDITECH IMMUTEST DRUG SCREEN PCP
    ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE
    LIVESURE PHENECYCLINE (PCP) SCREEN TESTS
    INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST
    INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST
    MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229
    AT HOME DRUG TEST, MODEL 9133 T
    BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160D
    MODIFICATION TO PROFILE -II
    STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541
    SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST
    URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A
    ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2
    ONTRAK TESTCUP 5, CAT. 07 6481 7
    SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL
    ONTRAK TESTCUP 5 M2K, CAT. 11 1850 1
    AT HOME DRUG TEST, MODEL 9133
    BIONIKE AQ PHENCYCLIDINE (PCP) TEST
    REDI-TEST PCP
    MICRO-STRIP FOR PHENCYCLIDINE METABOLITES
    VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE
    ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST
    AUTO-LYTE PCP EIA, MODEL #1254U
    QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST
    QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST
    QUICKSCREEN ONE STEP PCP SCREENING TEST
    MODIFIED CEDIA DAU PCP ASSAY
    ONTRAK TESTCUP 5 (MODIFICATION)

    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

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