21 CFR § 866.6050 - Ovarian adnexal mass assessment score test system.

---
identifier: "/us/cfr/t21/s866.6050"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.6050 - Ovarian adnexal mass assessment score test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.6050"
section_name: "Ovarian adnexal mass assessment score test system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "866"
part_name: "IMMUNOLOGY AND MICROBIOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "47 FR 50823, Nov. 9, 1982, unless otherwise noted."
cfr_part: "866"
---


# 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).

(c) *Black box warning.* Under section 520(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:

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