K153607 is an FDA 510(k) clearance for the ROMA Calculation Tool Using Elecsys Assays. This device is classified as a Ovarian Adnexal Mass Assessment Score Test System (Class II - Special Controls, product code ONX).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on June 15, 2016, 181 days after receiving the submission on December 17, 2015.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6050. 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..
| 510(k) Number | K153607 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2015 |
| Decision Date | June 15, 2016 |
| Days to Decision | 181 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | ONX — Ovarian Adnexal Mass Assessment Score Test System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6050 |
| 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. |