Lumipulse G ROMA
FDA 510(k) K160090 · Fujirebio Diagnostics,Inc.
510(k) numberK160090
Submission
- Device name
- Lumipulse G ROMA
- Applicant
- Fujirebio Diagnostics,Inc.
Malvern, PA, US - Received
- January 15, 2016
- Decision date
- May 16, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ONX – Ovarian Adnexal Mass Assessment Score Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6050
- Specialty
- Obstetrics/Gynecology
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…
Other 510(k)s with product code ONX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K153607 | ROMA Calculation Tool Using Elecsys AssaysONX · Traditional | Roche Diagnostics | 06/15/2016SE |
| K151502 | Architect RomaONX · Traditional | Fujirebio Diagnostics,Inc. | 04/28/2016SE |
| K150588 | OVA1 Next GenerationONX · Traditional | Vermillion, Inc. | 03/18/2016SE |
| K103358 | Roma (HE4 Eia + Architect Ca 125 II)ONX · Traditional | Fujirebio Diagnostics,Inc. | 09/01/2011SESU |
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Questions and answers
When was Lumipulse G ROMA cleared by the FDA?
Lumipulse G ROMA (K160090) received a 510(k) decision of Substantially Equivalent on May 16, 2016, 122 days after the submission was received.
What is the product code of K160090?
The FDA product code is ONX – Ovarian Adnexal Mass Assessment Score Test System, a Class II (moderate risk) device regulated under 21 CFR 866.6050.