510(k) · Decided
DecidedRoma (HE4 Eia + Architect CA 125 II)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujirebio Diagnostics,Inc. · ONX Ovarian Adnexal Mass Assessment Score Test System
Cleared on Sep 1, 2011 as substantially equivalent to DEN090004 (Vermillion, 2009) after a 289-day review. Its family tree reaches back 1 generation to 2009. 3 later devices descend from it.
- Decided
- Sep 1, 2011
- Review
- 289 days
- Class
- Class II
- Product code
- ONX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN090004 (2009). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backDEN090004 OVA1 TestVermillion · 2009
- This deviceK103358 Roma (HE4 Eia + Architect CA 125 II)Fujirebio Diagnostics,Inc. · 2011
- Descendant · cites it directly · 0 of its ownK153607 ROMA Calculation Tool Using Elecsys AssaysRoche Diagnostics · 2016
- Descendant · cites it directly · 0 of its ownK160090 Lumipulse G ROMAFujirebio Diagnostics,Inc. · 2016
- Descendant · cites it directly · 0 of its ownK151502 Architect RomaFujirebio Diagnostics,Inc. · 2016
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN090004 | OVA1 Test | Vermillion | 2009 | — |
| 0 (this device) | K103358 | Roma (HE4 Eia + Architect CA 125 II) | Fujirebio Diagnostics,Inc. | 2011 | — |
| +1 | K153607 | ROMA Calculation Tool Using Elecsys Assays | Roche Diagnostics | 2016 | — |
| +1 | K160090 | Lumipulse G ROMA | Fujirebio Diagnostics,Inc. | 2016 | — |
| +1 | K151502 | Architect Roma | Fujirebio Diagnostics,Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 3 | 0 |
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 |
|---|---|---|---|
| * | DEN090004 | OVA1 Test 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. | 2009 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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. 2011, 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?
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…
Read the full statement (180 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103358 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103358: Roma (HE4 Eia + Architect CA 125 II).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103358
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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