Axis-Shield Diagnostics, Ltd.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Axis-Shield Diagnostics, Ltd.” (first 2002, latest 2026), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 111 days. Since 2017 the median was 184 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 | 0 | — |
| 2017 | 1 | 105 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 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 184 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 | 5 | 5 |
| NHX | Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | 5 | 5 |
| 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 |
| MID | System, Test, Anticardiolipin Immunological | 1 | 1 |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 1 | 1 |
Review panels
- Clinical Chemistry (12)
- Immunology (10)
- Hematology (2)
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 |
| K172133 | ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay | CDD | 2017-10-27 | 105 |
| K121946 | AXIS-SHIELD ACVTIVE-B12 | CDD | 2013-03-22 | 262 |
| K121842 | ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C | LCP | 2012-12-12 | 170 |
| K112790 | AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON | LPS | 2012-05-07 | 224 |
| K112443 | ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) | CDD | 2011-12-19 | 117 |
| K110296 | AXIS-SHIELD ANTI-CCP | NHX | 2011-08-18 | 198 |
| K083868 | ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35 | NHX | 2009-09-25 | 270 |
14 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.
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 Diagnostics Limited (4 510(k)s)
- Axis-Shield Poc AS (4 510(k)s)
- Axis-Shield , Ltd. (3 510(k)s)
- Axis-Shield Biochemicals, Asa (2 510(k)s)
- Axis-Shield Doc AS (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Axis-Shield Diagnostics, Ltd.?
FDA lists 24 510(k) clearances under the applicant name “Axis-Shield Diagnostics, Ltd.” (first 2002, latest 2026), across 9 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 111 days. Since 2017: 184 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, 5); NHX (Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp), 5); JZO (System, Test, Thyroid Autoantibody, 3).
Next steps
- See all 24 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.