Diasorin Molecular, LLC: FDA clearances and approvals
Diasorin Molecular, LLC has 13 FDA 510(k) clearances (first 2018, latest 2026), plus 1 De Novo decision, across 10 product codes in 1 review panel. Median 510(k) review time: 98 days. Since 2017 its median was 98 days, against 147 days for all cleared 510(k)s in the same product codes. openFDA lists 8 product recalls by a recalling firm named Diasorin Molecular, LLC. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 4 | 74 |
| 2019 | 2 | 93 |
| 2020 | 1 | 78 |
| 2021 | 0 | — |
| 2022 | 2 | 603 |
| 2023 | 1 | 350 |
| 2024 | 0 | — |
| 2025 | 2 | 135 |
| 2026 | 1 | 133 |
Review time against the same product codes
Since 2017, Diasorin Molecular, LLC's cleared 510(k)s took a median 98 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 147 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | 3 | 3 |
| OZZ | Bordetella Pertussis Dna Assay System | 2 | 2 |
| PGI | Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples | 2 | 2 |
| NJR | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | 1 | 1 |
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 1 | 1 |
| PGX | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | 1 | 1 |
| PLO | Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System | 1 | 1 |
| QDZ | Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection | 1 | 1 |
| QQX | Respiratory Specimen Nucleic Acid Sars-Cov-2 Test | 1 | 1 |
| SBT | Device To Detect Microbial Colonization Directly From Clinical Specimens. | 1 | 0 |
Review panels
- Microbiology (14)
Most recent Diasorin Molecular, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260333 | LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit | PGX | 2026-06-15 | 133 |
| K251978 | LIAISON NES FLU A/B, RSV & COVID-19 | QOF | 2025-12-23 | 179 |
| K252387 | Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) | QOF | 2025-10-30 | 91 |
| K220963 | Simplexa COVID-19 & Flu A/B Direct | QOF | 2023-03-17 | 350 |
| K202755 | Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack | QDZ | 2022-11-05 | 775 |
| K212147 | Simplexa COVID-19 Direct | QQX | 2022-09-13 | 431 |
| K201505 | Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack | OCC | 2020-08-22 | 78 |
| K192376 | Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack | PGI | 2019-11-26 | 88 |
| K190219 | Simplexa VZV Direct, Simplexa VZV Positive Control Pack | PLO | 2019-05-13 | 98 |
| K183223 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | OZZ | 2018-12-19 | 29 |
3 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230092 | De Novo | Device To Detect Microbial Colonization Directly From Clinical Specimens. | 2024-07-15 |
Recalls
8 product recalls in 5 recall events; 4 initiated in the last five years. Most recent: 2023-06-14.
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.
Device clinical trials
Diasorin Molecular, LLC is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06672692: A Multi-Site Clinical Evaluation of the LIAISON NES FLU A/B, RSV & COVID-19 Assay in Symptomatic Patients (Recruiting, started 2024-09-30)
- NCT05897515: LIAISON NES Influenza (FLU) A/B & Coronavirus Disease 2019 (COVID-19) Clinical Agreement in Australia (Completed, started 2023-06-19)
Frequently asked questions
How many FDA 510(k) clearances does Diasorin Molecular, LLC have?
Diasorin Molecular, LLC has 13 FDA 510(k) clearances (first 2018, latest 2026), plus 1 De Novo decision, across 10 product codes in 1 review panel.
How long does FDA take to clear Diasorin Molecular, LLC's 510(k)s?
The median time from FDA receipt to decision across Diasorin Molecular, LLC's cleared 510(k)s is 98 days. Since 2017: 98 days, versus 147 days for all cleared 510(k)s in the same product codes.
What devices does Diasorin Molecular, LLC make?
Its most frequent FDA product codes are QOF (Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents, 3); OZZ (Bordetella Pertussis Dna Assay System, 2); PGI (Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples, 2).
Has Diasorin Molecular, LLC had device recalls?
openFDA lists 8 product recalls in 5 recall events by a recalling firm whose name matches Diasorin Molecular, LLC; the most recent began 2023-06-14. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 13 Diasorin Molecular, LLC clearances with predicates and recalls
- Run predicate analysis for product code QOF, Diasorin Molecular, LLC'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.