K151502 is an FDA 510(k) clearance for the ARCHITECT ROMA. This device is classified as a Ovarian Adnexal Mass Assessment Score Test System (Class II - Special Controls, product code ONX).
Submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on April 28, 2016, 329 days after receiving the submission on June 4, 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 | K151502 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2015 |
| Decision Date | April 28, 2016 |
| Days to Decision | 329 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. |