Roche Molecular Systems, Inc.: FDA filings under this applicant name
FDA lists 52 510(k) clearances under the applicant name “Roche Molecular Systems, Inc.” (first 1993, latest 2026), plus 15 PMA and 3 De Novo decisions, across 26 product codes in 5 review panels. Median 510(k) review time under this name: 173 days. Since 2017 the median was 168 days, against 139 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 | 298 |
| 2013 | 1 | 133 |
| 2014 | 2 | 56 |
| 2015 | 2 | 174 |
| 2016 | 0 | — |
| 2017 | 2 | 88 |
| 2018 | 2 | 100 |
| 2019 | 2 | 58 |
| 2020 | 2 | 28 |
| 2021 | 5 | 88 |
| 2022 | 3 | 213 |
| 2023 | 3 | 238 |
| 2024 | 0 | — |
| 2025 | 11 | 176 |
| 2026 | 6 | 182 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Roche Molecular Systems, Inc. took a median 168 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 139 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QEP | Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | 7 | 7 |
| LSL | Dna-Reagents, Neisseria | 6 | 6 |
| MZP | Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus | 6 | 2 |
| MKZ | Dna Probe, Nucleic Acid Amplification, Chlamydia | 5 | 5 |
| OZN | C. Difficile Toxin Gene Amplification Assay | 5 | 5 |
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 4 | 4 |
| OWD | Somatic Gene Mutation Detection System | 4 | 0 |
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | 4 | 4 |
| PAB | Cytomegalovirus (Cmv) Dna Quantitative Assay | 3 | 1 |
| QQX | Respiratory Specimen Nucleic Acid Sars-Cov-2 Test | 3 | 3 |
Plus 16 more product codes.
Review panels
- Microbiology (60)
- Pathology (5)
- Clinical Chemistry (2)
- Clinical Toxicology (2)
- Radiology (1)
Most recent Roche Molecular Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260047 | cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190) | PGX | 2026-08-28 | 233 |
| K260045 | cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190) | OZN | 2026-08-28 | 233 |
| K260021 | cobas® BV/CV | PQA | 2026-07-16 | 192 |
| K260917 | cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems | QEP | 2026-07-08 | 111 |
| K253759 | cobas liat CT/NG/MG nucleic acid test | QEP | 2026-05-15 | 171 |
| K253756 | cobas liat CT/NG nucleic acid test | QEP | 2026-05-15 | 171 |
| K243753 | cobas liat Bordetella panel nucleic acid test | OZZ | 2025-11-20 | 350 |
| K252484 | cobas HCV | MZP | 2025-11-03 | 88 |
| K252481 | cobas CMV | PAB | 2025-11-03 | 88 |
| K243455 | cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems | QOF | 2025-07-31 | 266 |
42 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN200015 | De Novo | Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna | 2020-07-30 |
| P190028 | PMA | cobas HPV for use on the cobas 6800/8800 Systems | 2020-04-03 |
| DEN190016 | De Novo | Culture-Based Short-Term Incubation Antimicrobial Resistance Assay | 2019-12-05 |
| P160041 | PMA | COBAS CMV | 2017-06-01 |
| P150044 | PMA | cobas EGFR MUTATION TEST v2 | 2016-09-28 |
Recalls
66 product recalls in 41 recall events; 5 initiated in the last five years. Most recent: 2022-12-21.
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 Medical Electronics, Inc. (16 510(k)s)
- Roche Diagnostics Operations (Rdo) (14 510(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 Molecular Systems, Inc.?
FDA lists 52 510(k) clearances under the applicant name “Roche Molecular Systems, Inc.” (first 1993, latest 2026), plus 15 PMA and 3 De Novo decisions, across 26 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 Molecular Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Roche Molecular Systems, Inc. is 173 days. Since 2017: 168 days, versus 139 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Roche Molecular Systems, Inc.?
The most frequent FDA product codes under this applicant name are QEP (Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections, 7); LSL (Dna-Reagents, Neisseria, 6); MZP (Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus, 6).
Next steps
- See all 52 Roche Molecular Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QEP, Roche Molecular Systems, Inc.'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.