§ 862.3270 Codeine test system.
Current through Sep 8, 2026 · Read all of Part 862
(a) 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.
(b) 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. 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.
[52 FR 16122, May 1, 1987, as amended at 84 FR 71798, Dec. 30, 2019; 91 FR 63486, Oct. 6, 2026]