FDA product code ONX: Ovarian Adnexal Mass Assessment Score Test System
ONX is the FDA product code for ovarian adnexal mass assessment score test system. It is a Class II device, regulated under 21 CFR 866.6050 and reviewed by the Immunology panel. FDA has cleared 5 510(k) submissions under ONX, from 3 different applicants. The average 510(k) review took 259 days (median 289). 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Ovarian Adnexal Mass Assessment Score Test System |
| Device class | Class II |
| Regulation | 21 CFR 866.6050 |
| Review panel | IM — Immunology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every ONX clearance
Top ONX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fujirebio Diagnostics,Inc. | 3 | 2016-05-16 |
| Roche Diagnostics | 1 | 2016-06-15 |
| Vermillion, Inc. | 1 | 2016-03-18 |
Most recent ONX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K153607 | Roche Diagnostics | ROMA Calculation Tool Using Elecsys Assays | 2016-06-15 | 181 |
| K160090 | Fujirebio Diagnostics,Inc. | Lumipulse G ROMA | 2016-05-16 | 122 |
| K151502 | Fujirebio Diagnostics,Inc. | ARCHITECT ROMA | 2016-04-28 | 329 |
| K150588 | Vermillion, Inc. | OVA1 Next Generation | 2016-03-18 | 375 |
| K103358 | Fujirebio Diagnostics,Inc. | ROMA (HE4 EIA + ARCHITECT CA 125 II) | 2011-09-01 | 289 |
Recalls for ONX devices
openFDA lists no recalls for product code ONX.
Frequently asked questions
What is FDA product code ONX?
ONX is the FDA product code for ovarian adnexal mass assessment score test system. It is a Class II device, regulated under 21 CFR 866.6050 and reviewed by the Immunology panel.
What device class is ONX?
Class II, regulation 21 CFR 866.6050. Typical premarket route: 510(k).
How long does a 510(k) take for product code ONX?
Across 5 cleared submissions the average was 259 days from receipt to decision (median 289).
Which companies have the most ONX clearances?
Fujirebio Diagnostics,Inc. (3); Roche Diagnostics (1); Vermillion, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ONX
- Run a recall and safety report across every ONX manufacturer
- Watch product code ONX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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