Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Roche Diagnostics Operations (Rdo) — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
132 daysmedian FDA review time
203 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K193053 | Tina-quant Hemoglobin A1cDx Gen.3 | Roche Diagnostics Operations (Rdo) | 2020-03-26 | 146 | 0 |
| K192072 | Tina-quant C-Reactive Protein IV | Roche Diagnostics Operations (Rdo) | 2020-02-21 | 203 | 0 |
| K183517 | Ammonia II | Roche Diagnostics Operations (Rdo) | 2019-02-08 | 52 | 0 |
| K182095 | Tina-quant Transferrin ver.2 (urine application) | Roche Diagnostics Operations (Rdo) | 2018-11-05 | 94 | 0 |
| K171080 | ALP IFCC Gen.2 | Roche Diagnostics Operations (Rdo) | 2017-05-10 | 29 | 0 |
| K160571 | cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assa | Roche Diagnostics Operations (Rdo) | 2016-12-19 | 294 | 0 |
| K162593 | HDL-Cholesterol Gen.4 | Roche Diagnostics Operations (Rdo) | 2016-10-19 | 33 | 0 |
| K161817 | Tina-quant Cystatin C Gen.2 | Roche Diagnostics Operations (Rdo) | 2016-07-27 | 26 | 0 |
| K160570 | Creatine Kinase | Roche Diagnostics Operations (Rdo) | 2016-05-25 | 86 | 1 |
| K152245 | ONLINE TDM Vancomycin Gen.3 | Roche Diagnostics Operations (Rdo) | 2016-01-08 | 151 | 0 |
| K151578 | Carbamazepine Gen 4 | Roche Diagnostics Operations (Rdo) | 2015-10-22 | 133 | 0 |
| K143691 | LDLC3 LDL-Cholesterol Gen.3 | Roche Diagnostics Operations (Rdo) | 2015-01-28 | 35 | 0 |
| K141925 | TOTAL PROTEIN URINE/CSF GEN.3 | Roche Diagnostics Operations (Rdo) | 2014-12-09 | 146 | 0 |
| K141928 | COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR | Roche Diagnostics Operations (Rdo) | 2014-11-25 | 132 | 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