Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QVP · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
265 daysmedian FDA review time
592 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252280 | Elecsys Anti-SARS-CoV-2 S | Roche Diagnostics | 2026-04-13 | 265 | 0 |
| K253839 | Elecsys Anti-SARS-CoV-2 | Roche Diagnostics | 2025-12-17 | 16 | 0 |
| K250768 | Elecsys Anti-SARS-CoV-2 | Roche Diagnostics | 2025-06-10 | 89 | 0 |
| DEN210040 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reage | Ortho-Clinical Diagnostics, Inc. | 2023-05-05 | 591 | 0 |
| DEN210038 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent | Ortho-Clinical Diagnostics, Inc. | 2023-05-05 | 592 | 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