Axis-Shield Diagnostics, Ltd.: FDA filings under this applicant name
FDA lists 28 510(k) clearances under 2 spellings of the applicant name “Axis-Shield Diagnostics, Ltd.” (first 2002, latest 2026), across 11 product codes in 3 review panels. Median 510(k) review time under this name: 125 days. Since 2017 the median was 204 days, against 232 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.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 197 |
| 2013 | 1 | 262 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 2 | 184 |
| 2017 | 1 | 105 |
| 2018 | 1 | 147 |
| 2019 | 1 | 269 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 271 |
| 2025 | 1 | 262 |
| 2026 | 1 | 97 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Axis-Shield Diagnostics, Ltd. took a median 204 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 232 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CDD | Radioassay, Vitamin B12 | 6 | 6 |
| NHX | Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | 6 | 6 |
| JZO | System, Test, Thyroid Autoantibody | 3 | 3 |
| LPS | Urinary Homocystine (Nonquantitative) Test System | 3 | 3 |
| NBC | Test, Natriuretic Peptide | 3 | 3 |
| LCP | Assay, Glycosylated Hemoglobin | 2 | 2 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 | 1 |
| GGT | Assay, Erythropoietin | 1 | 1 |
| JKR | Radioimmunoassay, Calcitonin | 1 | 1 |
| MID | System, Test, Anticardiolipin Immunological | 1 | 1 |
Plus 1 more product codes.
Review panels
- Clinical Chemistry (14)
- Immunology (11)
- Hematology (3)
Most recent Axis-Shield Diagnostics, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253539 | Alere NT-proBNP for Alinity i | NBC | 2026-02-18 | 97 |
| K241176 | Alere NT-proBNP for Alinity i Reagent Kit | NBC | 2025-01-16 | 262 |
| K233541 | ARCHITECT Active-B12 (Holotranscobalamin) | CDD | 2024-07-31 | 271 |
| K183088 | ADVIA Centaur Erythropoietin (EPO) assay | GGT | 2019-08-02 | 269 |
| K182012 | ADVIA Centaur Calcitonin (CALCT) assay | JKR | 2018-12-21 | 147 |
| K172133 | ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay | CDD | 2017-10-27 | 105 |
| K153551 | ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. | NHX | 2016-08-04 | 237 |
| K160757 | ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) | CDD | 2016-07-26 | 130 |
| K121946 | AXIS-SHIELD ACVTIVE-B12 | CDD | 2013-03-22 | 262 |
| K121842 | ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C | LCP | 2012-12-12 | 170 |
18 earlier clearances. See the full list in Caduvo.
Recalls
5 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2019-09-16.
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 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Axis-Shield Diagnostics, Ltd. (24)
- Axis-Shield Diagnostics Limited (4)
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.
- Axis-Shield Poc AS (4 510(k)s)
- Axis Biochemicals, Asa (3 510(k)s)
- Axis Orthopaedics (3 510(k)s)
- Axis-Shield Biochemicals, Asa (2 510(k)s)
- Axis-Shield , Ltd. (2 510(k)s)
- Axis Spine Technologies, Ltd. (2 510(k)s)
- Axis (1 510(k)s)
- Axis Health Care, LLC (1 510(k)s)
- Axis-Shield (1 510(k)s)
- Axis-Shield Doc AS (1 510(k)s)
- Axis Surgical Technologies, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Axis-Shield Diagnostics, Ltd.?
FDA lists 28 510(k) clearances under 2 spellings of the applicant name “Axis-Shield Diagnostics, Ltd.” (first 2002, latest 2026), across 11 product codes in 3 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 Axis-Shield Diagnostics, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Axis-Shield Diagnostics, Ltd. is 125 days. Since 2017: 204 days, versus 232 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Axis-Shield Diagnostics, Ltd.?
The most frequent FDA product codes under this applicant name are CDD (Radioassay, Vitamin B12, 6); NHX (Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp), 6); JZO (System, Test, Thyroid Autoantibody, 3).
Next steps
- See all 28 Axis-Shield Diagnostics, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code CDD, Axis-Shield Diagnostics, Ltd.'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.