# K153607: ROMA Calculation Tool Using Elecsys Assays

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Jun 15, 2016 after 181 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 5.

## Indications for use
ROMA Calculation Tool Using Elecsys Assays (RCTUEA) is a qualitative test for serum and plasma (K2-EDTA, K3-EDTA and Li-Heparin) that combines the results of the Elecsys HE4 assay, Elecsys CA 125 II assay and menopausal status into a numerical score. RCTUEA 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. RCTUEA 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. RCTUEA 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. The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers. PRECAUTION: RCTUEA 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 RCTUEA carries the risk of unnecessary testing, surgery and/or delayed diagnosis.

Source page: https://510kreport.com/device/K153607
Methodology: https://510kreport.com/methodology