DLN · Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)
Clinical Toxicology · 21 CFR 862.3250 · Class 2
Overview
| Product Code | DLN |
|---|---|
| Device Name | Hemagglutination, Cocaine Metabolites (Benzoylecgnonine) |
| 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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K950134 | URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE | E.I. Dupont DE Nemours & Co., Inc. | Mar 21, 1995 | SESE |
| K924113 | ABUSCREEN ONLINE FOR COCAINE METABOLITE | Roche Diagnostic Systems, Inc. | Dec 28, 1992 | SESE |
| K792429 | HIM TEST COCAINE | Tecknam, Inc. | Dec 7, 1979 | SESE |
| K760401 | COCAINE KIT, TOXI-PAK | J.T. Baker Chemical Co. | Aug 26, 1976 | SESE |
Top Applicants
- E.I. Dupont DE Nemours & Co., Inc. — 1 clearance
- J.T. Baker Chemical Co. — 1 clearance
- Roche Diagnostic Systems, Inc. — 1 clearance
- Tecknam, Inc. — 1 clearance
