OVA1 Next Generation
FDA 510(k) clearance K150588 · decided 2016-03-18
Clearance details
- K-number
- K150588
- Device name
- OVA1 Next Generation
- Applicant
- Vermillion, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-03-09
- Decision date
- 2016-03-18
- Days to decision
- 375 days
- Clearance type
- Traditional
- Product code
- ONX
- Device class
- 2
- Regulation number
- 866.6050
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ROMA Calculation Tool Using Elecsys Assays (K153607) | Roche Diagnostics | 2016-06-15 |
| Lumipulse G ROMA (K160090) | Fujirebio Diagnostics,Inc. | 2016-05-16 |
| ARCHITECT ROMA (K151502) | Fujirebio Diagnostics,Inc. | 2016-04-28 |
| ROMA (HE4 EIA + ARCHITECT CA 125 II) (K103358) | Fujirebio Diagnostics,Inc. | 2011-09-01 |
| OVA1 TEST (DEN090004) | Vermillion | 2009-09-11 |
Recalls involving this device
No recalls on record reference this clearance.