Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
CDD — Predicate Candidate Screening
78 FDA 510(k) clearances under this product code; the 50 most recent screened below.
80 daysmedian FDA review time
201 days90th percentile
78clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233541 | ARCHITECT Active-B12 (Holotranscobalamin) | Axis-Shield Diagnostics, Ltd. | 2024-07-31 | 271 | 0 |
| K223289 | Access Vitamin B12 | Beckman Coulter, Inc. | 2022-12-23 | 59 | 0 |
| K190298 | DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin | Beckman Coulter Biomedical GmbH | 2019-10-04 | 235 | 2 |
| K192064 | LIAISON Vitamin B12 | DiaSorin, Inc. | 2019-10-02 | 62 | 0 |
| K172133 | ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay | Axis-Shield Diagnostics, Ltd. | 2017-10-27 | 105 | 0 |
| K161721 | Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators S | Diazyme Laboratories | 2016-09-20 | 90 | 0 |
| K160757 | ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, A | Axis-Shield Diagnostics Limited | 2016-07-26 | 130 | 0 |
| K151786 | Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet | Roche Diagnostics | 2015-09-24 | 85 | 0 |
| K140496 | Access Vitamin B12 Assay, Access Ferritin Assay, Access Fola | Beckman Coulter, Inc. | 2014-09-16 | 201 | 3 |
| K133512 | LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA | Siemens Healthcare Diagnostics | 2014-01-02 | 48 | 0 |
| K121946 | AXIS-SHIELD ACVTIVE-B12 | Axis-Shield Diagnostics, Ltd. | 2013-03-22 | 262 | 0 |
| K121994 | DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, D | Siemens Healthcare Diagnostics, Inc. | 2012-11-30 | 147 | 0 |
| K111260 | A/C ENZYMATIC VITAMIN B6 ASSAY | Anticancer, Inc. | 2012-07-26 | 448 | 0 |
| K121314 | ARCHITECT B12 | Abbott Laboratories | 2012-05-17 | 15 | 0 |
| K112443 | ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) | Axis-Shield Diagnostics, Ltd. | 2011-12-19 | 117 | 0 |
| K110579 | ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHI | Abbott Laboratories | 2011-10-06 | 219 | 0 |
| K110413 | POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNEC | Beckman Coulter, Inc. | 2011-05-11 | 86 | 1 |
| K093631 | B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL | Siemens Healthcare Diagnostics | 2010-02-12 | 80 | 0 |
| K090588 | POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNEC | Beckman Coulter, Inc. | 2009-05-27 | 84 | 0 |
| K071224 | DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDG | Dade Behring, Inc. | 2007-11-13 | 195 | 1 |
| K062467 | AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATO | Axis-Shield Diagnostics, Ltd. | 2006-11-22 | 90 | 0 |
| K060929 | IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 T | Diagnostic Products Corporation | 2006-04-28 | 23 | 0 |
| K060755 | ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK | Roche Diagnostics Corp. | 2006-04-10 | 20 | 0 |
| K051327 | ABBOTT AXSYM B12 | Abbott Laboratories | 2005-08-03 | 75 | 0 |
| K041133 | MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCE | Bayer Healthcare, LLC | 2004-07-02 | 63 | 7 |
| K030655 | HOLOTC RIA | Axis-Shield Biochemicals, Asa | 2004-01-29 | 332 | 0 |
| K013899 | VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1 | Ortho-Clinical Diagnostics | 2002-01-24 | 62 | 1 |
| K993571 | BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENT | Bayer Corp. | 1999-12-16 | 56 | 0 |
| K984321 | VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1 | Ortho-Clinical Diagnostics, Inc. | 1999-01-22 | 50 | 0 |
| K973702 | ELECSYS VITAMIN B12 ASSAY | Boehringer Mannheim Corp. | 1997-11-13 | 48 | 0 |
| K973674 | ELECSYS FOLATE | Boehringer Mannheim Corp. | 1997-11-12 | 47 | 0 |
| K971177 | IMMULITE VITAMIN B12 (LKVB1,LKVB5) | Diagnostic Products Corp. | 1997-05-16 | 46 | 1 |
| K965186 | AXSYM B12 | Abbott Laboratories | 1997-03-24 | 90 | 0 |
| K964348 | AIA-PACK B12 ASSAY | Tosoh Medics, Inc. | 1997-01-13 | 74 | 0 |
| K955561 | BUHLMANN VITAMIN B6 REA | American Laboratory Products Co., Ltd. | 1996-05-23 | 169 | 0 |
| K955436 | ACCESS VITAMIN B12 ASSAY (MODIFICATION) | Bio-Rad Laboratories, Inc. | 1996-01-24 | 114 | 1 |
| K953455 | OPUS B12 | Behring Diagnostics, Inc. | 1995-08-23 | 35 | 0 |
| K951134 | CEDIA VITAMIN B12 (NO BOIL) ASSAY | Microgenics Corp. | 1995-07-11 | 120 | 0 |
| K941235 | VISTA B12 ASSAY | Syva Co. | 1994-08-15 | 153 | 0 |
| K933142 | ACCESS VITAMIN B12 ASSAY | Bio-Rad Laboratories, Inc. | 1993-11-05 | 130 | 0 |
| K933315 | RADIAS B12 ENZYME IMMUNOASSAY | Bio-Rad | 1993-08-25 | 49 | 0 |
| K924074 | STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED | Baxter Diagnostics, Inc. | 1992-10-26 | 75 | 0 |
| K920078 | AFFINITY B12 | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-02-14 | 37 | 0 |
| K913646 | CIBA CORNING ACS T3 IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1991-10-25 | 70 | 0 |
| K910343 | CIBA CORNING ACS VITAMIN B12 IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1991-03-06 | 36 | 0 |
| K904776 | CEDIA (R) VITAMIN B12/FOLATE ASSAY | Microgenics Corp. | 1990-11-20 | 29 | 0 |
| K883722 | CIBA CORNING MAGIC LITE VITAMIN B12 IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1988-11-04 | 65 | 0 |
| K860815 | SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB) | Diagnostic Products Corp. | 1986-07-11 | 129 | 0 |
| K854945 | MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1986-02-11 | 63 | 0 |
| K853224 | PHASE II B-12/FOLATE KIT | Medical & Scientific Designs, Inc. | 1985-10-03 | 63 | 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