FDA Product Code DJC: Thin Layer Chromatography, Methamphetamine
Leading manufacturers include Alfa Scientific Designs, Inc., Cordis Corp. and Medtox Diagnostics, Inc..
31
Total
31
Cleared
133d
Avg days
1978
Since
Growing category -
2 submissions in the last 2 years
vs 0 in the prior period
Review times increasing: avg
262d
recently vs 124d historically
FDA 510(k) Cleared Thin Layer Chromatography, Methamphetamine Devices (Product Code DJC)
31 devices
Cleared
Mar 16, 2026
Healgen® Accurate Oral Fluid Drug Test
Healgen Scientific, LLC
Toxicology
112d
Cleared
Mar 18, 2025
LYHER® Oral fluid Multi-Drug Test Kit (Cube)
Hangzhou Laihe Biotech Co., Ltd.
Toxicology
411d
Cleared
Dec 17, 2018
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.
Toxicology
258d
Cleared
Sep 20, 2018
OralTox Oral fluid Drug Test
Premier Biotech, Inc.
Toxicology
126d
Cleared
Feb 02, 2018
OralTox Oral Fluid Drug Test
Premier Biotech, Inc.
Toxicology
266d
Cleared
Jul 06, 2016
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.
Toxicology
84d
Cleared
Sep 27, 2013
WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300)
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology
36d
Cleared
Nov 13, 2002
INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST
Alfa Scientific Designs, Inc.
Toxicology
107d
Cleared
Jul 30, 2002
VERDICT-II
Medtox Diagnostics, Inc.
Toxicology
28d
Cleared
Nov 26, 2001
RAPIDONE-ECSTASY TEST
American Bio Medica Corp.
Toxicology
63d
Cleared
Jun 01, 2001
VERDICT -II METHAMPHETAMINE
Medtox Diagnostics, Inc.
Toxicology
128d
Cleared
Aug 14, 2000
INSTANT-VIEW METHAMPHETAMINE URINE DIP STRIP TEST
Alfa Scientific Designs, Inc.
Toxicology
230d
Cleared
Aug 04, 2000
INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST
Alfa Scientific Designs, Inc.
Toxicology
220d
Cleared
Jul 10, 2000
ONTRAK TESTCUP PRO-5, MODEL 1986678
Roche Diagnostics Corp.
Toxicology
73d
Cleared
Oct 06, 1999
REDI-SCREEN
Redwood Biotech, Inc.
Toxicology
20d
Cleared
Oct 24, 1978
DIALYSIS SYS., PDS 400 & RO 400
Physio-Control Corp.
Toxicology
105d
Cleared
Oct 17, 1978
KIDNEY, ARTIFICIAL
Bd Becton Dickinson Vacutainer Systems Preanalytic
Toxicology
99d
Cleared
Aug 31, 1978
KIDNEY, ARTIFICIAL, C-DAK 2.0
Cordis Corp.
Toxicology
42d
Cleared
Aug 31, 1978
KIDNEY, ARTIFICIAL, C-DAK 1.5
Cordis Corp.
Toxicology
42d
Cleared
Aug 17, 1978
A-V FISTULA NEEDLE
Bd Becton Dickinson Vacutainer Systems Preanalytic
Toxicology
15d
About Product Code DJC - Regulatory Context
510(k) Submission Activity
31 total 510(k) submissions under product code DJC since 1978, with 31 receiving FDA clearance (average review time: 133 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - DJC Product Code
Recent submissions under DJC have taken an average of 262 days to reach a decision - up from 124 days historically. Manufacturers should account for longer review timelines in current project planning.
DJC devices are reviewed by the Toxicology panel. Browse all Toxicology devices →