DNK · Thin Layer Chromatography, Morphine
Clinical Toxicology · 21 CFR 862.3640 · Class 2
Overview
| Product Code | DNK |
|---|---|
| Device Name | Thin Layer Chromatography, Morphine |
| 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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K151557 | EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine | Nantong Egens Biotech Co., Ltd. | Jul 16, 2015 | SESE |
| K150602 | CR3 Keyless Split Sample Cup Morphine - Methamphetamine | Guangzhou Wondfo Biotech Co., Ltd. | Apr 7, 2015 | SESE |
| K970579 | ONE STEP MORPHINE CARD TEST | Teco Diagnostics | Jul 3, 1997 | SESE |
| K853140 | MDI QUIK TEST NARCOTICS DRUG SCREEN | Medical Diagnostics, Ca. | Mar 3, 1986 | SESE |
Top Applicants
- Guangzhou Wondfo Biotech Co., Ltd. — 1 clearance
- Medical Diagnostics, Ca. — 1 clearance
- Nantong Egens Biotech Co., Ltd. — 1 clearance
- Teco Diagnostics — 1 clearance
