KLN · Radioimmunoassay, Cocaine Metabolite
Clinical Toxicology · 21 CFR 862.3250 · Class 2
Overview
| Product Code | KLN |
|---|---|
| Device Name | Radioimmunoassay, Cocaine Metabolite |
| 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 (14 of 14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K010868 | PSYCHEMEDICS RIA COCAINE ASSAY | Psychemedics Corp. | Nov 6, 2001 | SESE |
| K913867 | URINE COCAINE METABOLITE DIRECT RIA KIT (I-125) | Immunalysis Corporation | Sep 19, 1991 | SESE |
| K913722 | ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE | Roche Diagnostic Systems, Inc. | Sep 10, 1991 | SESE |
| K912756 | ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE | Roche Diagnostic Systems, Inc. | Jul 26, 1991 | SESE |
| K910123 | TARGET COCAINE METABOLITE-V | V-Tech, Inc. | Mar 19, 1991 | SESE |
| K910122 | TARGET COCAINE METABOLITE-R | V-Tech, Inc. | Mar 19, 1991 | SESE |
| K910044 | MILENIA COCAINE METABOLITE | Diagnostic Products Corp. | Feb 13, 1991 | SESE |
| K905730 | ABUSCREEN ONTRAK FOR COCAINE (200NG/ML) | Roche Diagnostic Systems, Inc. | Jan 15, 1991 | SESE |
| K904995 | ABUSCREEN ONLINE TM FOR COCAINE METABOLITE | Roche Diagnostic Systems, Inc. | Nov 28, 1990 | SESE |
| K880674 | MICROMEDIC CRACKPOT RIA KIT | Icn Micromedic Systems | Oct 6, 1988 | SESE |
| K871549 | RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125] | Immunalysis Corporation | Jun 16, 1987 | SESE |
| K870740 | COAT-A-COUNT COCAINE METABOLITE TKCN1 & TKCN5 | Diagnostic Products Corp. | Mar 19, 1987 | SESE |
| K862218 | DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT | Diagnostic Products Corp. | Jun 27, 1986 | SESE |
| K830480 | ABUSCREEN RADIOIMMUNOASSAY-COCAINE META | Hoffmann-La Roche, Inc. | Mar 24, 1983 | SESE |
Top Applicants
- Roche Diagnostic Systems, Inc. — 4 clearances
- Diagnostic Products Corp. — 3 clearances
- Immunalysis Corporation — 2 clearances
- V-Tech, Inc. — 2 clearances
- Hoffmann-La Roche, Inc. — 1 clearance
