---
kind: "section"
citation: "21 C.F.R. § 862.3280"
title: "21"
number: "862.3280"
heading: "Clinical toxicology control material."
url: "https://uscodex.org/cfr/21/862.3280"
---

# §862.3280. Clinical toxicology control material.

- (a) **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.
- (b) **Classification.** Class I (general controls). The device is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 862.9](/cfr/21/862.9.md).

## Notes

### Amendments

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000, 84 FR 71798, Dec. 30, 2019]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 52 FR 16122, May 1, 1987, unless otherwise noted.

### Amendments

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000, 84 FR 71798, Dec. 30, 2019]