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 Adjunct
| Device Type ID | 3115 |
| Device Name | Ovarian Adnexal Mass Assessment Score Test System |
| 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 Adjunct |
| 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 Adjunct |
| Target Area | Pelvic Adenexal Mass In Women; Ovaries |
| Regulation Description | Ovarian Adnexal Mass Assessment Score Test System. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.6050 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ONX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3115 |
| Device | Ovarian Adnexal Mass Assessment Score Test System |
| Product Code | ONX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ovarian Adnexal Mass Assessment Score Test System. |
| CFR Regulation Number | 866.6050 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ROCHE DIAGNOSTICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS OPERATIONS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VERMILLION, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |