QuidelOrtho: FDA 510(k) clearances across all its applicant names
FDA lists 494 510(k) clearances, 9 PMA and 5 De Novo decisions across the 10 applicant names Caduvo groups under QuidelOrtho, first 1977, latest 2026. Median 510(k) review time across these names: 64 days. Since 2017 the median was 99 days, against 159 days for all cleared 510(k)s in the same product codes. Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 4 | 138 |
| 2013 | 14 | 89 |
| 2014 | 6 | 82 |
| 2015 | 4 | 100 |
| 2016 | 8 | 89 |
| 2017 | 10 | 151 |
| 2018 | 6 | 90 |
| 2019 | 6 | 28 |
| 2020 | 2 | 26 |
| 2021 | 3 | 204 |
| 2022 | 3 | 210 |
| 2023 | 7 | 75 |
| 2024 | 3 | 183 |
| 2025 | 1 | 90 |
| 2026 | 3 | 248 |
The 10 FDA applicant names in this group
| Applicant name | 510(k) clearances | PMA | De Novo | Years |
|---|---|---|---|---|
| Quidel Corp. | 128 | 1 | 2 | 1983–2024 |
| Ortho-Clinical Diagnostics, Inc. | 126 | 7 | 2 | 1997–2025 |
| Ortho Diagnostic Systems, Inc. | 126 | 0 | 0 | 1981–1997 |
| Diagnostic Hybrids, Inc. | 36 | 0 | 1 | 1988–2010 |
| Johnson & Johnson Clinical Diagnostics, Inc. | 33 | 0 | 0 | 1995–1998 |
| Ortho Diagnostics, Inc. | 24 | 0 | 0 | 1977–1980 |
| Ortho Clinical Diagnostics | 16 | 1 | 0 | 2015–2024 |
| Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | 2 | 0 | 0 | 2026–2026 |
| Quidel Cardiovascular, Inc. | 2 | 0 | 0 | 2019–2020 |
| Ortho Clinical Diagnostics Inc. (QuidelOrtho) | 1 | 0 | 0 | 2026–2026 |
Review time against the same product codes
Since 2017, 510(k)s cleared under these names took a median 99 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 159 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 22 | 22 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 22 | 22 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 19 | 19 |
| GKZ | Counter, Differential Cell | 16 | 16 |
| KIR | Cells, Animal And Human, Cultured | 14 | 14 |
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 9 | 9 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 9 | 9 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 9 | 9 |
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | 8 | 8 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 8 | 8 |
Plus 179 more product codes.
Review panels
- Clinical Chemistry (191)
- Microbiology (160)
- Hematology (65)
- Immunology (47)
- Clinical Toxicology (25)
- Pathology (15)
- Obstetrics and Gynecology (2)
- Radiology (1)
Most recent QuidelOrtho 510(k) clearances
| 510(k) | Device | Applicant name | Product code | Decision date | Review days |
|---|---|---|---|---|---|
| K254264 | Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | QVF | 2026-09-04 | 248 |
| K254262 | Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA | Ortho Clinical Diagnostics Inc. (QuidelOrtho) | PSZ | 2026-09-04 | 248 |
| K254295 | Sofia Lyme FIA; Sofia 2 Campylobacter FIA | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | LSR | 2026-07-10 | 191 |
| K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent Pack | Ortho-Clinical Diagnostics, Inc. | MMI | 2025-10-29 | 90 |
| K241534 | VITROS Immunodiagnostic Products Syphilis Reagent Pack | Ortho Clinical Diagnostics | LIP | 2024-08-28 | 90 |
| K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack | Ortho Clinical Diagnostics | DHA | 2024-05-08 | 183 |
| K231795 | QuickVue COVID-19 Test | Quidel Corp. | QYT | 2024-03-22 | 276 |
| K232286 | Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument | Quidel Corp. | PGI | 2023-12-20 | 141 |
| K233688 | Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set | Quidel Corp. | QVF | 2023-12-13 | 26 |
| K221197 | VITROS Immunodiagnostic Products Intact PTH II Reagent Pack | Ortho Clinical Diagnostics | CEW | 2023-09-05 | 498 |
484 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN210040 | De Novo | Sars-Cov-2 Serology Test | 2023-05-05 |
| DEN210038 | De Novo | Sars-Cov-2 Serology Test | 2023-05-05 |
| DEN220039 | De Novo | Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings | 2023-03-08 |
| DEN140004 | De Novo | Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples | 2014-05-13 |
| DEN140005 | De Novo | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | 2014-04-16 |
Recalls
380 product recalls in 218 recall events under these names; 78 initiated in the last five years.
Recalling firms are matched to the applicant names above by name only, so recalls filed under other names are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
How this group is built
Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.
Quidel and Ortho Clinical Diagnostics combined in May 2022. Ortho was a Johnson & Johnson business until its 2014 sale to Carlyle; its J&J-era filings (Ortho Diagnostic Systems, Johnson & Johnson Clinical Diagnostics) are included. Diagnostic Hybrids acquired by Quidel 2010.
Sources
Frequently asked questions
How many FDA 510(k) clearances are listed across QuidelOrtho's applicant names?
FDA lists 494 510(k) clearances, 9 PMA and 5 De Novo decisions across the 10 applicant names Caduvo groups under QuidelOrtho, first 1977, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.
Which FDA applicant names does QuidelOrtho file under?
The names with the most 510(k) clearances in this group are Quidel Corp. (128); Ortho-Clinical Diagnostics, Inc. (126); Ortho Diagnostic Systems, Inc. (126); Diagnostic Hybrids, Inc. (36); Johnson & Johnson Clinical Diagnostics, Inc. (33). The full list of 10 names is on this page.
How long does FDA take to clear QuidelOrtho 510(k)s?
The median time from FDA receipt to decision across 510(k)s cleared under these names is 64 days. Since 2017 the median was 99 days, against 159 days for all cleared 510(k)s in the same product codes.
Does the QuidelOrtho count include acquired companies?
Yes. A group includes filings an acquired business made under its own name, including before the acquisition. Businesses that were sold are left out, and names whose ownership is unclear are not included. FDA does not group applicants; the sources for each grouping are listed on this page.
Next steps
- See all 494 QuidelOrtho clearances with predicates and recalls
- Run predicate analysis for product code JHI, QuidelOrtho's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls). Applicant names are matched exactly, with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this grouping or data.
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