510(k) · Cleared
ClearedROMA Calculation Tool Using Elecsys Assays
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · ONX Ovarian Adnexal Mass Assessment Score Test System
Cleared on Jun 15, 2016 as substantially equivalent to K103358 (Fujirebio Diagnostics,Inc., 2011) after a 181-day review. Its family tree reaches back 2 generations to 2009.
- Decided
- Jun 15, 2016
- Review
- 181 days
- Class
- Class II
- Product code
- ONX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN090004 (2009). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ONX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K103358 | Roma (HE4 Eia + Architect CA 125 II)Summary page 5…: ROMA (Risk of Ovarian Malignancy Algorithm) Device Name Product Code: ONX Predicate Device: Fujirebio ROMA (K103358) Establishment For the ROMA Calculation Tool Using Elecsys Assays (RCTUEA), the Registration Elecsys HE4 assay a… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K103358.
How does its category compare?
All ONX devicesONX Ovarian Adnexal Mass Assessment Score Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · ONX
4in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · ONX
255in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONX
No recall names ONX since 2007.
Adverse event reports per year · ONX
No MAUDE report names ONX since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 4 | 255 | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (185 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153607 · printed Nov 4, 2026
Cite this page
510(k) Report. “K153607: ROMA Calculation Tool Using Elecsys Assays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K153607
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026