DOE · Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
Clinical Toxicology · 21 CFR 862.3640 · Class 2
Overview
| Product Code | DOE |
|---|---|
| Device Name | Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep. |
| Regulation | 21 CFR 862.3640 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A morphine test system is a device intended to measure morphine, an addictive narcotic pain-relieving drug, and its analogs in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of morphine use or overdose and in monitoring levels of morphine and its analogs to ensure appropriate therapy.
Classification Rationale
Class II (special controls). A morphine 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 morphine 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 (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K010080 | INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST | Alfa Scientific Designs, Inc. | May 29, 2001 | SESE |
| K010079 | INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST | Alfa Scientific Designs, Inc. | May 29, 2001 | SESE |
| K011011 | LIVESURE MORPHINE SCREEN TEST | Pan Probe Biotech, Inc. | Apr 13, 2001 | SESE |
| K002418 | BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D | Branan Medical Corporation | Nov 22, 2000 | SESE |
| K951319 | ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION | Roche Diagnostic Systems, Inc. | Jun 1, 1995 | SESE |
| K935055 | ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF) | Roche Diagnostic Systems, Inc. | Aug 9, 1994 | SESE |
| K933572 | URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) | Immunalysis Corporation | Apr 6, 1994 | SESE |
| K881102 | MICROMEDIC MORPHINE RIA KIT | Icn Micromedic Systems | Jun 24, 1988 | SESE |
| K863913 | THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT | Diagnostic Products Corp. | Mar 19, 1987 | SESE |
| K864168 | MORPHINE ROCHE (R) EIA TEST | Roche Diagnostic Systems, Inc. | Mar 16, 1987 | SESE |
| K830462 | ABUSCREEN RADIOUMMUNOASSAY--URINE | Hoffmann-La Roche, Inc. | Mar 24, 1983 | SESE |
| K830460 | ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE | Hoffmann-La Roche, Inc. | Mar 24, 1983 | SESE |
Top Applicants
- Roche Diagnostic Systems, Inc. — 3 clearances
- Alfa Scientific Designs, Inc. — 2 clearances
- Hoffmann-La Roche, Inc. — 2 clearances
- Branan Medical Corporation — 1 clearance
- Diagnostic Products Corp. — 1 clearance
