21 CFR 862.3200 — Calibrators, Drug Mixture
Clinical Toxicology (TX) · Subpart D—Clinical Toxicology Test Systems · § 862.3200
Identification
A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)
Classification Rationale
Class II (special controls). 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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DKB | Calibrators, Drug Mixture | 2 | 94 | |
| DLJ | Calibrators, Drug Specific | 2 | 123 | |
| DNN | Calibrators, Ethyl Alcohol | 2 | 7 |
Special Controls
DKB — Calibrators, Drug Mixture
*Classification.* Class II (special controls). 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.
eCFR
DLJ — Calibrators, Drug Specific
*Classification.* Class II (special controls). 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.
eCFR
DNN — Calibrators, Ethyl Alcohol
*Classification.* Class II (special controls). 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.
eCFR
