DLB · Radioimmunoassay, Lsd (125-I)
Clinical Toxicology · 21 CFR 862.3580 · Class 2
Overview
| Product Code | DLB |
|---|---|
| Device Name | Radioimmunoassay, Lsd (125-I) |
| Regulation | 21 CFR 862.3580 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A lysergic acid diethylamide (LSD) test system is a device intended to measure lysergic acid diethylamide, a hallucinogenic drug, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of LSD use or overdose.
Classification Rationale
Class II (special controls). A lysergic acid diethylamide (LSD) 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 lysergic acid diethylamide (LSD) 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 (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K961436 | ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT) | Roche Diagnostic Systems, Inc. | Jun 21, 1996 | SESE |
| K955448 | EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS | Behring Diagnostics, Inc. | Feb 23, 1996 | SESE |
| K955814 | CEDIA DAU LSD ASSAY | Microgenics Corp. | Feb 9, 1996 | SESE |
| K954073 | STC DIAGNOSTICS LSD MICRO-PLATE EIA | Solarcare Technologies Corp,Inc. | Nov 29, 1995 | SESE |
| K891167 | COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT | Diagnostic Products Corp. | May 3, 1989 | SESE |
| K874270 | REVISED LABELING FOR LSD TEST KIT | Roche Diagnostic Systems, Inc. | Nov 13, 1987 | SESE |
| K860525 | ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD | Roche Diagnostic Systems, Inc. | Apr 11, 1986 | SESE |
Top Applicants
- Roche Diagnostic Systems, Inc. — 3 clearances
- Behring Diagnostics, Inc. — 1 clearance
- Diagnostic Products Corp. — 1 clearance
- Microgenics Corp. — 1 clearance
- Solarcare Technologies Corp,Inc. — 1 clearance
