Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Roche Diagnostics Operations — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
218 daysmedian FDA review time
433 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241220 | Tina-quant Lipoprotein(a) Gen.2 Molarity | Roche Diagnostics Operations | 2025-01-24 | 268 | 0 |
| K233454 | ONLINE TDM Methotrexate | Roche Diagnostics Operations | 2024-02-20 | 123 | 0 |
| K163633 | cobas HbA1c Test, cobas b 101 system | Roche Diagnostics Operations | 2017-07-28 | 218 | 0 |
| K121610 | COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY | Roche Diagnostics Operations | 2013-08-08 | 433 | 0 |
| K113072 | TINA-QUANT ALBUMIN GEN.2 | Roche Diagnostics Operations | 2012-05-14 | 210 | 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