DJC · Class II · 21 CFR 862.3610

FDA Product Code DJC: Thin Layer Chromatography, Methamphetamine

Leading manufacturers include Alfa Scientific Designs, Inc., Premier Biotech, Inc. and Bd Becton Dickinson Vacutainer Systems Preanalytic.

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
1–24 of 31
Cleared Mar 16, 2026
Healgen® Accurate Oral Fluid Drug Test
K253705
Healgen Scientific, LLC
Toxicology · 112d
Cleared Mar 18, 2025
LYHER® Oral fluid Multi-Drug Test Kit (Cube)
K240287
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
K180878
Shanghai Venture Bio-Tech Co., Ltd.
Toxicology · 258d
Cleared Sep 20, 2018
OralTox Oral fluid Drug Test
K181305
Premier Biotech, Inc.
Toxicology · 126d
Cleared Feb 02, 2018
OralTox Oral Fluid Drug Test
K171403
Premier Biotech, Inc.
Toxicology · 266d
Cleared Sep 27, 2013
WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300)
K132630
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 36d
Cleared Nov 13, 2002
INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST
K022501
Alfa Scientific Designs, Inc.
Toxicology · 107d
Cleared Aug 14, 2000
INSTANT-VIEW METHAMPHETAMINE URINE DIP STRIP TEST
K994406
Alfa Scientific Designs, Inc.
Toxicology · 230d
Cleared Aug 04, 2000
INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST
K994400
Alfa Scientific Designs, Inc.
Toxicology · 220d
Cleared Jul 10, 2000
ONTRAK TESTCUP PRO-5, MODEL 1986678
K001356
Roche Diagnostics Corp.
Toxicology · 73d
Cleared Oct 24, 1978
DIALYSIS SYS., PDS 400 & RO 400
K781156
Physio-Control Corp.
Toxicology · 105d
Cleared Oct 17, 1978
KIDNEY, ARTIFICIAL
K781153
Bd Becton Dickinson Vacutainer Systems Preanalytic
Toxicology · 99d
Cleared Aug 31, 1978
KIDNEY, ARTIFICIAL, C-DAK 2.0
K781237
Cordis Corp.
Toxicology · 42d
Cleared Aug 31, 1978
KIDNEY, ARTIFICIAL, C-DAK 1.5
K781238
Cordis Corp.
Toxicology · 42d
Cleared Aug 17, 1978
A-V FISTULA NEEDLE
K781331
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 →