---
kind: "section"
citation: "21 C.F.R. § 866.6050"
title: "21"
number: "866.6050"
heading: "Ovarian adnexal mass assessment score test system."
url: "https://uscodex.org/cfr/21/866.6050"
---

# §866.6050. Ovarian adnexal mass assessment score test system.

- (a) **Identification.** An ovarian/adnexal mass assessment test system is a device that measures one or more proteins in serum or plasma. It yields a single result for the likelihood that an adnexal pelvic mass in a woman, for whom surgery is planned, is malignant. The test is for adjunctive use, in the context of a negative primary clinical and radiological evaluation, to augment the identification of patients whose gynecologic surgery requires oncology expertise and resources.
- (b) **Classification.** Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System.” For the availability of this guidance document, see [§ 866.1(e)](/cfr/21/866.1.md?p=e).
- (c) **Black box warning.** Under [section 520(e)](/cfr/21/520.md?p=e) of the Federal Food, Drug, and Cosmetic Act these devices are subject to the following restriction: A warning statement must be placed in a black box and must appear in all advertising, labeling, and promotional material for these devices. That warning statement must read:

## Notes

### Amendments

[76 FR 16294, Mar. 23, 2011, as amended at 76 FR 82131, Dec. 30, 2011]

### 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

[76 FR 16294, Mar. 23, 2011, as amended at 76 FR 82131, Dec. 30, 2011]