LAE · High Pressure Liquid Chromatography, Codeine
Clinical Toxicology · 21 CFR 862.3270 · Class 2
Overview
| Product Code | LAE |
|---|---|
| Device Name | High Pressure Liquid Chromatography, Codeine |
| Regulation | 21 CFR 862.3270 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A codeine test system is a device intended to measure codeine (a narcotic pain-relieving drug) in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of codeine use or overdose and in monitoring levels of codeine to ensure appropriate therapy.
Classification Rationale
Class II (special controls). A codeine 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 codeine 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K851480 | VYGON GUEDEL AIRWAY 511 VYGON BERMANN/OROPHAR AIRW | Vygon Corp. | May 7, 1985 | SESE |
| K832590 | MOUTH-TO-MOUTH SHIELD APPLICATOR | Mem, Inc. | Oct 14, 1983 | SESE |
Top Applicants
- Mem, Inc. — 1 clearance
- Vygon Corp. — 1 clearance
