---
kind: "section"
citation: "21 C.F.R. § 862.1075"
title: "21"
number: "862.1075"
heading: "Androstenedione test system."
url: "https://uscodex.org/cfr/21/862.1075"
---

# §862.1075. Androstenedione test system.

- (a) **Identification.** An androstenedione test system is a device intended to measure androstenedione (a substance secreted by the testes, ovary, and adrenal glands) in serum. Adrostenedione measurements are used in the diagnosis and treatment of females with excessive levels of androgen (male sex hormone) production.
- (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 [§ 862.9](/cfr/21/862.9.md).

## Notes

### Amendments

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]

### 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 2305, Jan. 14, 2000]