Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ONX — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
289 daysmedian FDA review time
375 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K153607 | ROMA Calculation Tool Using Elecsys Assays | Roche Diagnostics | 2016-06-15 | 181 | 0 |
| K160090 | Lumipulse G ROMA | Fujirebio Diagnostics,Inc. | 2016-05-16 | 122 | 0 |
| K151502 | ARCHITECT ROMA | Fujirebio Diagnostics,Inc. | 2016-04-28 | 329 | 0 |
| K150588 | OVA1 Next Generation | Vermillion, Inc. | 2016-03-18 | 375 | 0 |
| K103358 | ROMA (HE4 EIA + ARCHITECT CA 125 II) | Fujirebio Diagnostics,Inc. | 2011-09-01 | 289 | 0 |
| DEN090004 | OVA1 TEST | Vermillion | 2009-09-11 | 51 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda