BEUDAMED
    Product Code: DJC FDA class 2 21 CFR 862.3610

    Thin Layer Chromatography, Methamphetamine

    Clinical Toxicology

    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.

    View on FDA
    510(k)s
    31
    FEI Numbers
    53
    Registration Numbers
    53
    Unique Applicants
    23
    Years Active
    48

    Basic Information

    Product Code
    DJC
    Device Class
    FDA class 2
    Regulation Number
    862.3610
    Medical Specialty
    Clinical Toxicology
    Review Panel
    TX
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 31 510(k) clearances via K numbers.

    K Number Device Name
    K253705 Healgen® Accurate Oral Fluid Drug Test
    K240287 LYHER® Oral fluid Multi-Drug Test Kit (Cube)
    K180878 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
    K181305 OralTox Oral fluid Drug Test
    K171403 OralTox Oral Fluid Drug Test
    K161044 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)
    K132630 WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300)
    K080347 UNISCAN -DOA SYSTEM
    K060355 ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000
    K060896 MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT
    K053033 ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000
    K031497 AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST
    K022388 STARTOX DRUG OF ABUSE SCREENING TEST (4)
    K022501 INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST
    K022141 VERDICT-II
    K011185 PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY
    K013180 RAPIDONE-ECSTASY TEST
    K010226 VERDICT -II METHAMPHETAMINE
    K002265 BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE DRUG SCREEN TEST
    K002587 BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUG SCREEN TEST
    K994406 INSTANT-VIEW METHAMPHETAMINE URINE DIP STRIP TEST
    K994400 INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST
    K001356 ONTRAK TESTCUP PRO-5, MODEL 1986678
    K993100 REDI-SCREEN
    K781156 DIALYSIS SYS., PDS 400 & RO 400
    K781153 KIDNEY, ARTIFICIAL
    K781140 CUTTER RESIFLEX FOLEY CATHETERS
    K781238 KIDNEY, ARTIFICIAL, C-DAK 1.5
    K781237 KIDNEY, ARTIFICIAL, C-DAK 2.0
    K781110 BANDAGE, COMPRESSION, FISTULAID
    K781331 A-V FISTULA NEEDLE

    FEI Numbers

    This FDA classification entry is associated with 53 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 53 registration numbers. Click on an entry to view related FDA registrations.