ABUSCREEN(R) ONTRAK(TM) FOR COCAINE
Device Facts
| Record ID | K881815 |
|---|---|
| Device Name | ABUSCREEN(R) ONTRAK(TM) FOR COCAINE |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product Code | DIO · Clinical Toxicology |
| Decision Date | Jul 29, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3250 |
| Device Class | Class 2 |
Regulatory Classification
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.
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).
