Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Axis-Shield Diagnostics, Ltd. — Predicate Candidate Screening
24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
117 daysmedian FDA review time
270 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253539 | Alere NT-proBNP for Alinity i | Axis-Shield Diagnostics, Ltd. | 2026-02-18 | 97 | 0 |
| K241176 | Alere NT-proBNP for Alinity i Reagent Kit | Axis-Shield Diagnostics, Ltd. | 2025-01-16 | 262 | 0 |
| K233541 | ARCHITECT Active-B12 (Holotranscobalamin) | Axis-Shield Diagnostics, Ltd. | 2024-07-31 | 271 | 0 |
| K172133 | ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay | Axis-Shield Diagnostics, Ltd. | 2017-10-27 | 105 | 0 |
| K121946 | AXIS-SHIELD ACVTIVE-B12 | Axis-Shield Diagnostics, Ltd. | 2013-03-22 | 262 | 0 |
| K121842 | ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C | Axis-Shield Diagnostics, Ltd. | 2012-12-12 | 170 | 0 |
| K112790 | AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON | Axis-Shield Diagnostics, Ltd. | 2012-05-07 | 224 | 0 |
| K112443 | ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) | Axis-Shield Diagnostics, Ltd. | 2011-12-19 | 117 | 0 |
| K110296 | AXIS-SHIELD ANTI-CCP | Axis-Shield Diagnostics, Ltd. | 2011-08-18 | 198 | 0 |
| K083868 | ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST) | Axis-Shield Diagnostics, Ltd. | 2009-09-25 | 270 | 1 |
| K083222 | AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, | Axis-Shield Diagnostics, Ltd. | 2009-07-31 | 270 | 1 |
| K073640 | ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS | Axis-Shield Diagnostics, Ltd. | 2008-04-24 | 120 | 0 |
| K072686 | AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C C | Axis-Shield Diagnostics, Ltd. | 2008-03-17 | 175 | 0 |
| K063347 | AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS | Axis-Shield Diagnostics, Ltd. | 2007-03-20 | 134 | 0 |
| K062467 | AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATO | Axis-Shield Diagnostics, Ltd. | 2006-11-22 | 90 | 0 |
| K041866 | ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY ( | Axis-Shield Diagnostics, Ltd. | 2004-09-29 | 82 | 0 |
| K033606 | ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE | Axis-Shield Diagnostics, Ltd. | 2004-01-30 | 74 | 0 |
| K031177 | DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M | Axis-Shield Diagnostics, Ltd. | 2003-06-19 | 66 | 0 |
| K023285 | DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA | Axis-Shield Diagnostics, Ltd. | 2002-10-09 | 23 | 1 |
| K021516 | DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP | Axis-Shield Diagnostics, Ltd. | 2002-07-23 | 74 | 1 |
| K020687 | DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300 | Axis-Shield Diagnostics, Ltd. | 2002-05-02 | 59 | 0 |
| K020349 | ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STAN | Axis-Shield Diagnostics, Ltd. | 2002-05-02 | 87 | 0 |
| K020348 | ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING | Axis-Shield Diagnostics, Ltd. | 2002-05-02 | 87 | 0 |
| K020156 | DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T | Axis-Shield Diagnostics, Ltd. | 2002-03-06 | 48 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda