DIW · Hemagglutination Inhibition, Methadone
Clinical Toxicology · 21 CFR 862.3620 · Class 2
Overview
| Product Code | DIW |
|---|---|
| Device Name | Hemagglutination Inhibition, Methadone |
| Regulation | 21 CFR 862.3620 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.
Classification Rationale
Class II (special controls). A methadone 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 methadone 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 |
|---|---|---|---|---|
| K950182 | URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE | E.I. Dupont DE Nemours & Co., Inc. | Mar 21, 1995 | SESE |
| K930845 | ROCHE ABUSCREEN ONTRAK FOR METHADONE | Roche Diagnostic Systems, Inc. | Apr 20, 1993 | SESE |
| K801509 | HI-M-TEST FOR METHADONE TEST #2 | Technam, Inc. | Jul 14, 1980 | SESE |
| K760075 | KIT, METHADONE (TOXI-PAK IMMUNO HI) | J.T. Baker Chemical Co. | Jul 20, 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
- Technam, Inc. — 1 clearance
