K103358 is an FDA 510(k) clearance for the ROMA (HE4 EIA + ARCHITECT CA 125 II). 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 September 1, 2011, 289 days after receiving the submission on November 16, 2010.
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 | K103358 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | November 16, 2010 |
| Decision Date | September 01, 2011 |
| Days to Decision | 289 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. |