---
kind: "section"
citation: "21 C.F.R. § 866.5750"
title: "21"
number: "866.5750"
heading: "Radioallergosorbent (RAST) immunological test system."
url: "https://uscodex.org/cfr/21/866.5750"
---

# §866.5750. Radioallergosorbent (RAST) immunological test system.

- (a) **Identification.** A radioallergosorbent immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the allergen antibodies (antibodies which cause an allergic reaction) specific for a given allergen. Measurement of specific allergen antibodies may aid in the diagnosis of asthma, allergies, and other pulmonary disorders.
- (b) **Classification.** Class II (special controls). The device, when intended to detect any of the allergens included in Table 1 in this paragraph, 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 [§ 866.9](/cfr/21/866.9.md).

## Notes

### Amendments

[47 FR 50823, Nov. 9, 1982, as amended at 84 FR 71800, Dec. 30, 2019]

### Authority

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

### Source

Source: 47 FR 50823, Nov. 9, 1982, unless otherwise noted.

### Amendments

[47 FR 50823, Nov. 9, 1982, as amended at 84 FR 71800, Dec. 30, 2019]