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U.S. Department of Health and Human Services

Product Classification

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Device ovarian adnexal mass assessment score test system
Regulation Description Ovarian adnexal mass assessment score test system.
Definition An ovarian/adnexal mass assessment test is a devicem that measures one or more proteins in serum.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 isn for adjunctive use, in teh context of a negative primary clinical and radiological evaluation, to augmrent the identification of patienets whose gynecologic surgery requires oncology expertise and resources.
Physical State An ovarian/adnexal mass assessment test is a devicem that measures one or more proteins in serum. 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 isn for adjunctive use, in teh context of a negative primary clinical and radiological evaluation, to augmrent the identification of patienets whose gynecologic surgery requires oncology expertise and resources.
Technical Method An ovarian/adnexal mass assessment test is a devicem that measures one or more proteins in serum. 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 isn for adjunctive use, in teh context of a negative primary clinical and radiological evaluation, to augmrent the identification of patienets whose gynecologic surgery requires oncology expertise and resources.
Target Area pelvic adenexal mass in women; ovaries
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Immunology
Product CodeONX
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.6050
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System
Third Party Review Not Third Party Eligible
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