# K160090: Lumipulse G ROMA

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: May 16, 2016 after 122 days
- Product code: ONX (Ovarian Adnexal Mass Assessment Score Test System)
- Device class: 2
- Regulation: 21 CFR 866.6050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN090004 (2009). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103358: Roma (HE4 Eia + Architect CA 125 II), Fujirebio Diagnostics,Inc. (2011) Summary page 6.

## Indications for use
Lumipulse® G Risk of Ovarian Malignancy Algorithm (ROMA®) is a qualitative serum and plasma (lithium heparin or dipotassium EDTA) test that combines the results of Lumipulse G HE4, Lumipulse G CA 125II and menopausal status into a numerical score. Lumipulse G ROMA is intended to aid in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery. Lumipulse G ROMA is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. Lumipulse G ROMA must be interpreted in conjunction with an independent clinical and radiological assessment. The test is not intended as a screening or stand-alone diagnostic assay. PRECAUTION: Lumipulse G ROMA should not be used without an independent clinical /radiological evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of Lumipulse G ROMA carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.

Source page: https://510kreport.com/device/K160090
Methodology: https://510kreport.com/methodology