QIAGEN GmbH: FDA clearances and approvals
QIAGEN GmbH has 16 FDA 510(k) clearances (first 2012, latest 2026), plus 11 PMA and 1 De Novo decisions, across 14 product codes in 4 review panels. Median 510(k) review time: 90 days. Since 2017 its median was 119 days, against 124 days for all cleared 510(k)s in the same product codes. openFDA lists 6 product recalls by a recalling firm named QIAGEN GmbH.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 88 |
| 2013 | 0 | — |
| 2014 | 2 | 94 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 168 |
| 2019 | 1 | 148 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 4 | 158 |
| 2025 | 4 | 58 |
| 2026 | 2 | 154 |
Review time against the same product codes
Since 2017, QIAGEN GmbH's cleared 510(k)s took a median 119 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 124 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OWD | Somatic Gene Mutation Detection System | 7 | 0 |
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 5 | 5 |
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | 3 | 3 |
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 2 | 2 |
| PSU | Jak2 Gene Mutation Detection Test | 2 | 1 |
| MAQ | Kit, Dna Detection, Human Papillomavirus | 1 | 0 |
| NCD | Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis | 1 | 0 |
| OOI | Real Time Nucleic Acid Amplification System | 1 | 1 |
| OQO | Herpes Simplex Virus Nucleic Acid Amplification Assay | 1 | 1 |
| OZN | C. Difficile Toxin Gene Amplification Assay | 1 | 1 |
Plus 4 more product codes.
Review panels
- Microbiology (17)
- Pathology (9)
- Clinical Chemistry (1)
- Clinical Toxicology (1)
Most recent QIAGEN GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254194 | QIAstat-Dx BCID GPF Plus AMR Panel | PAM | 2026-08-06 | 226 |
| K254032 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | PCH | 2026-03-09 | 83 |
| K252329 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | PCH | 2025-10-22 | 89 |
| K250080 | QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini | QOF | 2025-08-27 | 226 |
| K250324 | QIAstat-Dx GI Panel 2 Mini B | PCH | 2025-02-28 | 23 |
| K243813 | QIAstat-Dx GI Panel 2 Mini B&V | PCH | 2025-01-08 | 28 |
| K242256 | QIAstat-Dx Meningitis/Encephalitis (ME) Panel | PLO | 2024-10-29 | 90 |
| K242353 | QIAstat-Dx Respiratory Panel Mini | QOF | 2024-10-25 | 78 |
| K220062 | QIAstat-Dx Gastrointestinal Panel 2 | PCH | 2024-05-31 | 872 |
| K233100 | QIAstat-Dx® Respiratory Panel Plus | QOF | 2024-05-10 | 227 |
6 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P210002 | PMA | therascreen PDGFRA RGQ PCR Kit | 2023-06-29 |
| P190026 | PMA | therascreen BRAF V600E RGQ PCR Kit | 2020-04-15 |
| P190004 | PMA | therascreen PIK3CA RGQ PCR Kit | 2019-05-24 |
| P190001 | PMA | therascreen PIK3CA RGQ PCR Kit | 2019-05-24 |
| P180043 | PMA | therascreen FGFR RGQ RT-PCR Kit | 2019-04-12 |
Recalls
6 product recalls in 5 recall events; 4 initiated in the last five years. Most recent: 2023-08-22.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does QIAGEN GmbH have?
QIAGEN GmbH has 16 FDA 510(k) clearances (first 2012, latest 2026), plus 11 PMA and 1 De Novo decisions, across 14 product codes in 4 review panels.
How long does FDA take to clear QIAGEN GmbH's 510(k)s?
The median time from FDA receipt to decision across QIAGEN GmbH's cleared 510(k)s is 90 days. Since 2017: 119 days, versus 124 days for all cleared 510(k)s in the same product codes.
What devices does QIAGEN GmbH make?
Its most frequent FDA product codes are OWD (Somatic Gene Mutation Detection System, 7); PCH (Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System, 5); QOF (Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents, 3).
Has QIAGEN GmbH had device recalls?
openFDA lists 6 product recalls in 5 recall events by a recalling firm whose name matches QIAGEN GmbH; the most recent began 2023-08-22. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 16 QIAGEN GmbH clearances with predicates and recalls
- Run predicate analysis for product code OWD, QIAGEN GmbH's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.