---
kind: "section"
citation: "21 C.F.R. § 862.1150"
title: "21"
number: "862.1150"
heading: "Calibrator."
url: "https://uscodex.org/cfr/21/862.1150"
---

# §862.1150. Calibrator.

- (a) **Identification.** A 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. (See also [§ 862.2](/cfr/21/862.2.md) in this part.)
- (b) **Classification.** Class II (special 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 84 FR 71796, 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 84 FR 71796, Dec. 30, 2019]