FDA 510K for Ovarian Adnexal Mass Assessment Score Test System
An “Ovarian Adnexal Mass Assessment Score Test System” is a medical device, classified as an In Vitro Diagnostic (IVD) test, that analyzes a blood sample to generate a score indicating the likelihood of malignancy in a woman with a suspected ovarian adnexal mass, intended to be used alongside clinical evaluation and imaging to help guide surgical decision-making, particularly when the primary assessment suggests a low risk of cancer; it is not meant to be a standalone diagnostic tool for ovarian cancer.
Intended Use of Ovarian Adnexal Mass Assessment Score Test System
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 gynaecologic surgery requires oncology expertise and resources.
For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for Ovarian Adnexal Mass Assessment Score Test System
FDA 510K for Ovarian Adnexal Mass Assessment Score Test System Device Code and Regulation Number
| S.
NO |
Product Code | Device | Regulation Number | Device Class |
| 1 | ONX | Ovarian Adnexal Mass Assessment Score Test System | 866.605 | 2 |
Ovarian Adnexal Mass Assessment Score Test System
Intended Use:
It is a test which is a supplementary tool to assess the likelihood of malignancy when clinical and radiological evaluations do not indicate cancer. Designed for serum and plasma samples (K2-EDTA, K3-EDTA, and Li-Heparin), it combines results from five immunoassays and menopausal status to generate a numerical score. This test helps determine the malignancy risk in women over 18 with an ovarian adnexal mass scheduled for surgery, who have not yet been referred to an oncologist. It is not intended for screening or as a standalone diagnostic tool.
Device Description:
Test consists of software, instruments, assays and reagents. The software incorporates the results of serum biomarker concentrations from five immunoassays to calculate a single, unitless numeric result indicating a low or high risk of ovarian malignancy.
Performance Testing (Analytical) for Ovarian Adnexal Mass Assessment Score Test System
- Reagent Stability
- Precision/Reproducibility
- Detection studies- Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ)
- Traceability (controls, calibrators, or method)
- Accuracy
- Analytical specificity
Clinical Testing:
No Guidance available for 510k submission