# K103358: Roma (HE4 Eia + Architect CA 125 II)

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: Sep 1, 2011 after 289 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: 1 generation back to DEN090004 (2009). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN090004: OVA1 Test, Vermillion (2009). Our reading of the summary gave K081754, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN090004, OVA1 Test (Vermillion), granted Sep 11, 2009; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K153607: ROMA Calculation Tool Using Elecsys Assays (2016), 0 descendants of its own
- K160090: Lumipulse G ROMA (2016), 0 descendants of its own
- K151502: Architect Roma (2016), 0 descendants of its own

## Indications for use
For In Vitro Diagnostic Use Only. The Risk of Ovarian Malignancy Algorithm (ROMA™) is a qualitative serum test that combines the results of HE4 EIA, ARCHITECT CA 125 II™ and menopausal status into a numerical score. 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. 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. 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: ROMA (HE4 EIA + ARCHITECT CA 125 II) 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 ROMA (HE4 EIA + ARCHITECT CA 125 II) carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.

Source page: https://510kreport.com/device/K103358
Methodology: https://510kreport.com/methodology