# K151502: Architect Roma

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: Apr 28, 2016 after 329 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
ARCHITECT Risk of Ovarian Malignancy Algorithm (ROMA) is a qualitative serum test that combines the results of ARCHITECT HE4, ARCHITECT CA 125 II and menopausal status into a numerical score. ARCHITECT 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. ARCHITECT 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. ARCHITECT 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: ARCHITECT 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 ARCHITECT ROMA carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.

Source page: https://510kreport.com/device/K151502
Methodology: https://510kreport.com/methodology