JXO · Enzyme Immunoassay, Cocaine
Clinical Toxicology · 21 CFR 862.3250 · Class 2
Overview
| Product Code | JXO |
|---|---|
| Device Name | Enzyme Immunoassay, Cocaine |
| Regulation | 21 CFR 862.3250 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.
Classification Rationale
Class II (special controls). A cocaine and cocaine metabolite 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 cocaine and cocaine metabolite 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 (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K201228 | Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair | Psychemedics Corporation | Jun 25, 2021 | SESE |
| K111925 | PSYCHEMEDICS COCAINE EIA | Psychemedics Corp. | May 1, 2012 | SESE |
| K923314 | AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY | Serex, Inc. | Aug 24, 1992 | SESE |
| K921140 | STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIA | Solarcare Technologies Corp,Inc. | Aug 20, 1992 | SESE |
| K915785 | STC DIAGNOSTICS BENZOYLECGONINE EIA | Solarcare Technologies Corp,Inc. | Mar 11, 1992 | SESE |
| K913737 | IL TEST(TM) COCAINE | Instrumentation Laboratory CO | Dec 3, 1991 | SESE |
Top Applicants
- Solarcare Technologies Corp,Inc. — 2 clearances
- Instrumentation Laboratory CO — 1 clearance
- Psychemedics Corp. — 1 clearance
- Psychemedics Corporation — 1 clearance
- Serex, Inc. — 1 clearance
