DJC · Thin Layer Chromatography, Methamphetamine
Clinical Toxicology · 21 CFR 862.3610 · Class 2
Overview
| Product Code | DJC |
|---|---|
| Device Name | Thin Layer Chromatography, Methamphetamine |
| Regulation | 21 CFR 862.3610 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.
Classification Rationale
Class II (special controls). A methamphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Special Controls
*Classification.* Class II (special controls). A methamphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Recent Cleared Devices (20 of 31)
Showing 20 most recent of 31 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253705 | Healgen® Accurate Oral Fluid Drug Test | Healgen Scientific,, LLC | Mar 16, 2026 | SESE |
| K240287 | LYHER® Oral fluid Multi-Drug Test Kit (Cube) | Hangzhou Laihe Biotech Co., Ltd. | Mar 18, 2025 | SESE |
| 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 | Shanghai Venture Bio-Tech Co., Ltd. | Dec 17, 2018 | SESE |
| K181305 | OralTox Oral fluid Drug Test | Premier Biotech, Inc. | Sep 20, 2018 | SESE |
| K171403 | OralTox Oral Fluid Drug Test | Premier Biotech, Inc. | Feb 2, 2018 | SESE |
| 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) | Assure Tech. (Hangzhou) Co, Ltd. | Jul 6, 2016 | SESE |
| K132630 | WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300) | Guangzhou Wondfo Biotech Co., Ltd. | Sep 27, 2013 | SESE |
| K080347 | UNISCAN -DOA SYSTEM | Taiwan Unison Biotech, Inc. | Oct 9, 2008 | SESE |
| K060355 | ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000 | Acro Biotech, LLC | Aug 7, 2006 | SESE |
| K060896 | MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT | Varian, Inc. | Jun 9, 2006 | SESE |
| K053033 | ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000 | Acro Biotech, LLC | Jun 6, 2006 | SESE |
| K031497 | AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST | Amedica Biotech, Inc. | Oct 17, 2003 | SESE |
| K022388 | STARTOX DRUG OF ABUSE SCREENING TEST (4) | Starplex Scientific, Inc. | Feb 27, 2003 | SESE |
| K022501 | INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST | Alfa Scientific Designs, Inc. | Nov 13, 2002 | SESE |
| K022141 | VERDICT-II | Medtox Diagnostics, Inc. | Jul 30, 2002 | SESE |
| K011185 | PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY | Psychemedics Corp. | Jan 24, 2002 | SESE |
| K013180 | RAPIDONE-ECSTASY TEST | American Bio Medica Corp. | Nov 26, 2001 | SESE |
| K010226 | VERDICT -II METHAMPHETAMINE | Medtox Diagnostics, Inc. | Jun 1, 2001 | SESE |
| K002265 | BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE DRUG SCREEN TEST | Branan Medical Corporation | Nov 27, 2000 | SESE |
| K002587 | BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUG SCREEN TEST | Branan Medical Corporation | Nov 22, 2000 | SESE |
Top Applicants
- Alfa Scientific Designs, Inc. — 3 clearances
- Acro Biotech, LLC — 2 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 2 clearances
- Branan Medical Corporation — 2 clearances
- Cordis Corp. — 2 clearances
