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e-CFR data is current as of February 25, 2021

Title 21Chapter ISubchapter HPart 866Subpart G → §866.6050

Title 21: Food and Drugs
Subpart G—Tumor Associated Antigen immunological Test Systems

§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:

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

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