LDJ · Enzyme Immunoassay, Cannabinoids
Clinical Toxicology · 21 CFR 862.3870 · Class 2
Overview
| Product Code | LDJ |
|---|---|
| Device Name | Enzyme Immunoassay, Cannabinoids |
| Regulation | 21 CFR 862.3870 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds include delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.
Classification Rationale
Class II (special controls). A cannabinoid 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 cannabinoid 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 151)
Showing 20 most recent of 151 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K232732 | Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50 | Co-Innovation Biotech Co., Ltd. | Jan 17, 2024 | SESE |
| K232604 | LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette) | Hangzhou Laihe Biotech Co., Ltd. | Jan 10, 2024 | SESE |
| K223162 | Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT | Healgen Scientific,, LLC | Mar 17, 2023 | SESE |
| K192515 | BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 | Shenzhen Bioeasy Biotechnology Co., Ltd. | Oct 11, 2019 | SESE |
| K153741 | CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test | Hangzhou Clongene Biotech Co., Ltd. | Mar 18, 2016 | SESE |
| K152643 | EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana | Nantong Egens Biotech Co., Ltd. | Nov 2, 2015 | SESE |
| K151203 | Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set | Immunalysis Corporation | Jun 5, 2015 | SESE |
| K141320 | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls | Lin-Zhi International, Inc. | May 28, 2015 | SESE |
| K142408 | FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) | Polymed Therapeutics, Inc. | Sep 25, 2014 | SESE |
| K140546 | HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST | Healgen Scientific,, LLC | Jun 6, 2014 | SESE |
| K132096 | RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR | Biophor Diagnostics, Inc. | Oct 18, 2013 | SESE |
| K130213 | QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE | Lumiquick Diagnostics, Inc. | Oct 18, 2013 | SESE |
| K122633 | TOXCUP DRUG SCREEN CUP | Branan Medical Corp. | Feb 7, 2013 | SESE |
| K122759 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA) | Omega Laboratories, Inc. | Dec 5, 2012 | SESE |
| K121557 | WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST | Guangzhou Wondfo Biotech Co., Ltd. | Jul 25, 2012 | SESE |
| K111929 | PSYCHEMEDICS CANNABINOIDS EIA | Psychemedics Corp. | May 1, 2012 | SESE |
| K102428 | WUNDER TEST | Hien Helen Nguyen | Apr 18, 2012 | SESE |
| K110239 | LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL | Lin-Zhi International, Inc. | Jun 23, 2011 | SESE |
| K110182 | CANNABINOIDS URINE TEST | Guangzhou Wondfo Biotech Co., Ltd. | May 20, 2011 | SESE |
| K101744 | THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY | Microgenics Corp. | Apr 8, 2011 | SESE |
Top Applicants
- Syva Co. — 17 clearances
- Roche Diagnostic Systems, Inc. — 11 clearances
- Abbott Laboratories — 8 clearances
- Microgenics Corp. — 5 clearances
- ACON Laboratories, Inc. — 4 clearances
