21 CFR 866.6050 — Ovarian Adnexal Mass Assessment Score Test System
Obstetrics/Gynecology (OB) · Part 866 Subpart G—Tumor Associated Antigen Immunological Test Systems · § 866.6050
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.
Classification Rationale
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| ONX | Ovarian Adnexal Mass Assessment Score Test System | 2 | 6 | 3rd Party |
Special Controls
ONX — Ovarian Adnexal Mass Assessment Score Test System
The device is classified as Class II under regulation 21 CFR 866.6050 with special controls. The special control guidance document, "Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System" accompanies this device.
De Novo Order DEN090004
ONX — Ovarian Adnexal Mass Assessment Score Test System
*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:
eCFR
ONX — Ovarian Adnexal Mass Assessment Score Test System
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).
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