21 CFR 862.3280 — Heavy Metals Control Materials
Clinical Toxicology (TX) · Subpart D—Clinical Toxicology Test Systems · § 862.3280
Identification
A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.
Classification Rationale
Class I (general 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 |
|---|---|---|---|---|
| DIE | Heavy Metals Control Materials | 1 | 5 | |
| DIF | Drug Mixture Control Materials | 1 | 202 | |
| DJK | Digitoxin Control Serum, Ria | 1 | 1 | |
| DKC | Alcohol Control Materials | 1 | 11 | |
| DMP | Digoxin Control Serum, Ria | 1 | 4 | |
| LAS | Drug Specific Control Materials | 1 | 83 | |
| LAW | Theophylline Control Materials | 1 | 4 | |
| LAX | Lidocaine Control Materials | 1 | 1 | |
| LAY | Methotrexate Control Materials | 1 | 0 | |
| LAZ | N-Acetylprocainamide Control Materials | 1 | 4 | |
| LBA | Procainamide Control Materials | 1 | 1 |
