Roche Diagnostics Operations (Rdo): FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Roche Diagnostics Operations (Rdo)” (first 2014, latest 2020), across 13 product codes in 3 review panels. Median 510(k) review time under this name: 113 days. Since 2017 the median was 94 days, against 220 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Roche Diagnostics, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 2 | 139 |
| 2015 | 2 | 84 |
| 2016 | 5 | 86 |
| 2017 | 1 | 29 |
| 2018 | 1 | 94 |
| 2019 | 1 | 52 |
| 2020 | 2 | 174 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Roche Diagnostics Operations (Rdo) took a median 94 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 220 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PDJ | Hemoglobin A1c Test System | 2 | 2 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 | 1 |
| DCN | System, Test, C-Reactive Protein | 1 | 1 |
| DDG | Transferrin, Antigen, Antiserum, Control | 1 | 1 |
| DKB | Calibrators, Drug Mixture | 1 | 1 |
| JHS | Differential Rate Kinetic Method, Cpk Or Isoenzymes | 1 | 1 |
| JIF | Enzymatic Method, Ammonia | 1 | 1 |
| JIQ | Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) | 1 | 1 |
| KLT | Enzyme Immunoassay, Carbamazepine | 1 | 1 |
| LBR | Ldl & Vldl Precipitation, Hdl | 1 | 1 |
Plus 3 more product codes.
Review panels
- Clinical Chemistry (9)
- Clinical Toxicology (3)
- Immunology (2)
Most recent Roche Diagnostics Operations (Rdo) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K193053 | Tina-quant Hemoglobin A1cDx Gen.3 | PDJ | 2020-03-26 | 146 |
| K192072 | Tina-quant C-Reactive Protein IV | DCN | 2020-02-21 | 203 |
| K183517 | Ammonia II | JIF | 2019-02-08 | 52 |
| K182095 | Tina-quant Transferrin ver.2 (urine application) | DDG | 2018-11-05 | 94 |
| K171080 | ALP IFCC Gen.2 | CJE | 2017-05-10 | 29 |
| K160571 | cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay | PDJ | 2016-12-19 | 294 |
| K162593 | HDL-Cholesterol Gen.4 | LBS | 2016-10-19 | 33 |
| K161817 | Tina-quant Cystatin C Gen.2 | NDY | 2016-07-27 | 26 |
| K160570 | Creatine Kinase | JHS | 2016-05-25 | 86 |
| K152245 | ONLINE TDM Vancomycin Gen.3 | LEH | 2016-01-08 | 151 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Roche Diagnostics Operations (Rdo).
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Roche Diagnostics Corp. (451 510(k)s)
- Roche Diagnostic Systems, Inc. (296 510(k)s)
- Roche Molecular Systems, Inc. (52 510(k)s)
- Roche Medical Electronics, Inc. (16 510(k)s)
- Roche Analytical Instruments, Inc. (11 510(k)s)
- Roche Diabetes Care, Inc. (10 510(k)s)
- Roche Diagnostics Operations (7 510(k)s)
- Roche Diagnostics GmbH (5 510(k)s)
- Roche Diagnostics/Boehringer Mannheim GmbH (3 510(k)s)
- Roche (2 510(k)s)
- Roche Diabetes Care GmbH (2 510(k)s)
- Roche Professional Diagnostics (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Roche Diagnostics Operations (Rdo)?
FDA lists 14 510(k) clearances under the applicant name “Roche Diagnostics Operations (Rdo)” (first 2014, latest 2020), across 13 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Roche Diagnostics Operations (Rdo)?
The median time from FDA receipt to decision across 510(k)s cleared under the name Roche Diagnostics Operations (Rdo) is 113 days. Since 2017: 94 days, versus 220 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Roche Diagnostics Operations (Rdo)?
The most frequent FDA product codes under this applicant name are PDJ (Hemoglobin A1c Test System, 2); CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, 1); DCN (System, Test, C-Reactive Protein, 1).
Next steps
- See all 14 Roche Diagnostics Operations (Rdo) clearances with predicates and recalls
- Run predicate analysis for product code PDJ, Roche Diagnostics Operations (Rdo)'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.