Ortho-Clinical Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 142 510(k) clearances under 3 spellings of the applicant name “Ortho-Clinical Diagnostics, Inc.” (first 1997, latest 2025), plus 8 PMA and 2 De Novo decisions, across 82 product codes in 5 review panels. Median 510(k) review time under this name: 58 days. Since 2017 the median was 90 days, against 173 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 QuidelOrtho, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 208 |
| 2013 | 3 | 146 |
| 2014 | 0 | — |
| 2015 | 2 | 145 |
| 2016 | 3 | 148 |
| 2017 | 3 | 285 |
| 2018 | 2 | 90 |
| 2019 | 5 | 28 |
| 2020 | 1 | 26 |
| 2021 | 2 | 324 |
| 2022 | 3 | 210 |
| 2023 | 3 | 90 |
| 2024 | 2 | 136 |
| 2025 | 1 | 90 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ortho-Clinical Diagnostics, Inc. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 173 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 13 | 13 |
| MMI | Immunoassay Method, Troponin Subunit | 6 | 6 |
| JFY | Enzymatic Method, Creatinine | 5 | 5 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 5 | 5 |
| JIT | Calibrator, Secondary | 4 | 4 |
| JIX | Calibrator, Multi-Analyte Mixture | 4 | 4 |
| SEI | Qualitative And Quantitative Hepatitis B Virus Antibody Assays | 4 | 0 |
| CGZ | Electrode, Ion-Specific, Chloride | 3 | 3 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 3 | 3 |
| DHX | System, Test, Carcinoembryonic Antigen | 3 | 3 |
Plus 72 more product codes.
Review panels
- Clinical Chemistry (93)
- Immunology (24)
- Microbiology (17)
- Clinical Toxicology (16)
- Hematology (2)
Most recent Ortho-Clinical Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent Pack | MMI | 2025-10-29 | 90 |
| K241534 | VITROS Immunodiagnostic Products Syphilis Reagent Pack | LIP | 2024-08-28 | 90 |
| K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack | DHA | 2024-05-08 | 183 |
| K221197 | VITROS Immunodiagnostic Products Intact PTH II Reagent Pack | CEW | 2023-09-05 | 498 |
| K231517 | VITROS Immunodiagnostic Products CEA Reagent Pack | DHX | 2023-08-23 | 90 |
| K231525 | VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack | NIG | 2023-08-09 | 75 |
| K221355 | VITROS Immuodiagnostic Products CA 125 II Reagent Pack | LTK | 2022-12-12 | 216 |
| K213626 | VITROS AFP | LOJ | 2022-06-15 | 210 |
| K212648 | VITROS Immunodiagnostic Products CK-MB Reagent Pack | JHX | 2022-01-28 | 158 |
| K201312 | VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack | NBC | 2021-10-04 | 504 |
132 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN210038 | De Novo | Sars-Cov-2 Serology Test | 2023-05-05 |
| DEN210040 | De Novo | Sars-Cov-2 Serology Test | 2023-05-05 |
| P100001 | PMA | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS | 2011-07-20 |
| P090028 | PMA | VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS | 2011-05-11 |
| P030026 | PMA | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATOR | 2004-03-04 |
Recalls
354 product recalls in 195 recall events; 71 initiated in the last five years. Most recent: 2025-07-29.
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.
FDA spellings included
FDA records this applicant under 3 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Ortho-Clinical Diagnostics, Inc. (111)
- Ortho-Clinical Diagnostics (24)
- Ortho Clinical Diagnostics (17)
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.
- Ortho Diagnostic Systems, Inc. (126 510(k)s)
- Ortho Development Corp. (64 510(k)s)
- Ortho Diagnostics, Inc. (24 510(k)s)
- Ortho Tec, LLC (22 510(k)s)
- Ortho Pharmaceutical Corp. (9 510(k)s)
- Ortho Source (9 510(k)s)
- Ortho Organizers, Inc. (8 510(k)s)
- Ortho Kinetics Corp. (7 510(k)s)
- Ortho Instruments (6 510(k)s)
- Ortho Kinematics, Inc. (6 510(k)s)
- Ortho Solutions Limited (6 510(k)s)
- Ortho Solutions UK , Ltd. (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ortho-Clinical Diagnostics, Inc.?
FDA lists 142 510(k) clearances under 3 spellings of the applicant name “Ortho-Clinical Diagnostics, Inc.” (first 1997, latest 2025), plus 8 PMA and 2 De Novo decisions, across 82 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 Ortho-Clinical Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ortho-Clinical Diagnostics, Inc. is 58 days. Since 2017: 90 days, versus 173 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ortho-Clinical Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 13); MMI (Immunoassay Method, Troponin Subunit, 6); JFY (Enzymatic Method, Creatinine, 5).
Next steps
- See all 142 Ortho-Clinical Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJX, Ortho-Clinical Diagnostics, 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.