Roche Diagnostics Operations: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Roche Diagnostics Operations” (first 2012, latest 2025), plus 2 PMA decisions, across 9 product codes in 5 review panels. Median 510(k) review time under this name: 210 days. Since 2017 the median was 218 days, against 231 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 |
|---|---|---|
| 2012 | 1 | 210 |
| 2013 | 3 | 151 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 218 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 123 |
| 2025 | 1 | 268 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Roche Diagnostics Operations took a median 218 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 231 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DCF | Albumin, Antigen, Antiserum, Control | 1 | 1 |
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | 1 | 1 |
| LAO | Enzyme Immunoassay, Methotrexate | 1 | 1 |
| LCP | Assay, Glycosylated Hemoglobin | 1 | 1 |
| LFR | Glucose Dehydrogenase, Glucose | 1 | 1 |
| LOM | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | 1 | 0 |
| MZO | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus | 1 | 0 |
| NBW | System, Test, Blood Glucose, Over The Counter | 1 | 1 |
| PDJ | Hemoglobin A1c Test System | 1 | 1 |
Review panels
- Clinical Chemistry (3)
- Immunology (2)
- Microbiology (2)
- Hematology (1)
- Clinical Toxicology (1)
Most recent Roche Diagnostics Operations 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241220 | Tina-quant Lipoprotein(a) Gen.2 Molarity | DFC | 2025-01-24 | 268 |
| K233454 | ONLINE TDM Methotrexate | LAO | 2024-02-20 | 123 |
| K163633 | cobas HbA1c Test, cobas b 101 system | LCP | 2017-07-28 | 218 |
| K131366 | ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM | LFR | 2013-10-11 | 151 |
| K131029 | ACCU-CHEK AVIVA PLUS TEST STRIP | NBW | 2013-08-09 | 119 |
| K121610 | COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY | PDJ | 2013-08-08 | 433 |
| K113072 | TINA-QUANT ALBUMIN GEN.2 | DCF | 2012-05-14 | 210 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P140021 | PMA | ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV | 2015-06-11 |
| P130015 | PMA | ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG | 2014-03-14 |
Recalls
151 product recalls in 83 recall events; 8 initiated in the last five years. Most recent: 2026-01-20.
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. (456 510(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 Diagnostics Operations (Rdo) (14 510(k)s)
- Roche Diabetes Care, Inc. (12 510(k)s)
- Roche Analytical Instruments, Inc. (11 510(k)s)
- Roche Diagnostics/Boehringer Mannheim GmbH (3 510(k)s)
- Roche (2 510(k)s)
- Roche Professional Diagnostics (2 510(k)s)
- Roche Diabetes Care AG (1 510(k)s)
- Roche Diagnostics Hematology, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Roche Diagnostics Operations?
FDA lists 7 510(k) clearances under the applicant name “Roche Diagnostics Operations” (first 2012, latest 2025), plus 2 PMA decisions, across 9 product codes in 5 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?
The median time from FDA receipt to decision across 510(k)s cleared under the name Roche Diagnostics Operations is 210 days. Since 2017: 218 days, versus 231 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Roche Diagnostics Operations?
The most frequent FDA product codes under this applicant name are DCF (Albumin, Antigen, Antiserum, Control, 1); DFC (Lipoprotein, Low-Density, Antigen, Antiserum, Control, 1); LAO (Enzyme Immunoassay, Methotrexate, 1).
Next steps
- See all 7 Roche Diagnostics Operations clearances with predicates and recalls
- Run predicate analysis for product code DCF, Roche Diagnostics Operations'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.