LAY · Methotrexate Control Materials
Clinical Toxicology · 21 CFR 862.3280 · Class 1
Overview
| Product Code | LAY |
|---|---|
| Device Name | Methotrexate Control Materials |
| Regulation | 21 CFR 862.3280 |
| Device Class | Class 1 |
| Review Panel | Clinical Toxicology |
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
