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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: DJC FDA class 2

    Thin Layer Chromatography, Methamphetamine

    Clinical Toxicology

    View full classification →

    The Thin Layer Chromatography Methamphetamine test is a laboratory assay that employs thin layer chromatographic separation to detect and identify methamphetamine in urine or other biological specimens, used in drug of abuse screening and forensic toxicology. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3610 within the Clinical Toxicology specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    30 matches
    K Number
    Device Name
    LYHER® Oral fluid Multi-Drug Test Kit (Cube)
    BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx
    OralTox Oral fluid Drug Test
    OralTox Oral Fluid Drug Test
    AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
    WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300)
    UNISCAN -DOA SYSTEM
    ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000
    MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT
    ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000
    AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST
    STARTOX DRUG OF ABUSE SCREENING TEST (4)
    INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST
    VERDICT-II
    PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY
    RAPIDONE-ECSTASY TEST
    VERDICT -II METHAMPHETAMINE
    BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE DRUG SCREEN TEST
    BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUG SCREEN TEST
    INSTANT-VIEW METHAMPHETAMINE URINE DIP STRIP TEST
    INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST
    ONTRAK TESTCUP PRO-5, MODEL 1986678
    REDI-SCREEN
    DIALYSIS SYS., PDS 400 & RO 400
    KIDNEY, ARTIFICIAL
    CUTTER RESIFLEX FOLEY CATHETERS
    KIDNEY, ARTIFICIAL, C-DAK 2.0
    KIDNEY, ARTIFICIAL, C-DAK 1.5
    BANDAGE, COMPRESSION, FISTULAID
    A-V FISTULA NEEDLE

    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