LAT · Radioimmunoassay, Cannabinoid(S)
Clinical Toxicology · 21 CFR 862.3870 · Class 2
Overview
| Product Code | LAT |
|---|---|
| Device Name | Radioimmunoassay, Cannabinoid(S) |
| 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 (16 of 16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K011426 | PSYCHEMEDICS RIA CANNABINOID ASSAY | Psychemedics Corp. | May 3, 2002 | SESE |
| K961620 | ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100 | Roche Diagnostic Systems, Inc. | Jun 13, 1996 | SESE |
| K936135 | SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATION | Sudormed, Inc. | Jun 10, 1996 | SESE |
| K914507 | DOUBLE ANTIBODY CANNABIONOIDS/QUAIL DETER IN URINE | Diagnostic Products Corp. | Dec 18, 1991 | SESE |
| K913414 | ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT | Roche Diagnostic Systems, Inc. | Sep 25, 1991 | SESE |
| K913865 | URINE THC DIRECT RIA KIT (I-125) | Immunalysis Corporation | Sep 18, 1991 | SESE |
| K912574 | ABUSCREEN ONLINE FOR THC (50 AND 100) | Roche Diagnostic Systems, Inc. | Aug 12, 1991 | SESE |
| K904996 | ABUSCREEN ONLINE TM FOR THC | Roche Diagnostic Systems, Inc. | Jan 11, 1991 | SESE |
| K843534 | ORAL THC-CANNABINOIDS DIRECT RIA KIT | Immunalysis Corporation | Oct 30, 1984 | SESE |
| K833911 | URINE THC CANNABINOIDS DIRECT RIA KIT | Immunalysis Corporation | Jan 24, 1984 | SESE |
| K821965 | ORAL THC-CANNABINOIDS DIRECT RIA KIT | Immunalysis Corporation | Jul 20, 1982 | SESE |
| K820903 | THC-CANNABINOIDS DIRECT URINE RIA KIT | Immunalysis Corporation | May 5, 1982 | SESE |
| K820391 | ABUSCREEN RADIOIMMUNOASSAY FOR CANNABI | Hoffmann-La Roche, Inc. | Mar 8, 1982 | SESE |
| K800246 | EMIT -D.A.U. CANNABINOID URINE ASSAY | Syva Co. | Feb 26, 1980 | SESE |
| K791649 | TETRAHYDROCANNALBINOL DIRECT BLOOD KIT | Immunalysis Corporation | Oct 11, 1979 | SESE |
| K781048 | THC DIRECT RIA KIT | Immunalysis Corporation | Oct 3, 1978 | SESE |
Top Applicants
- Immunalysis Corporation — 7 clearances
- Roche Diagnostic Systems, Inc. — 4 clearances
- Diagnostic Products Corp. — 1 clearance
- Hoffmann-La Roche, Inc. — 1 clearance
- Psychemedics Corp. — 1 clearance
