Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MRG · Predicate Candidate Screening
46 FDA 510(k) clearances under this product code; the 50 most recent screened below.
154 daysmedian FDA review time
290 days90th percentile
46clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232587 | MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminesc | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2024-04-12 | 231 | 0 |
| K221817 | ALFIS Vitamin D, ALFIS-3 Analyzer | Immunostics Inc., | 2023-09-22 | 457 | 0 |
| K223503 | Access 25(OH) Vitamin D Total | Beckman Coulter, Inc. | 2023-01-19 | 58 | 0 |
| K210901 | Elecsys Vitamin D total III | Roche Diagnostics | 2021-09-01 | 159 | 0 |
| K200509 | ADVIA Centaur Vitamin D Total (VitD) | Siemens Healthcare Diagnostics, Inc. | 2020-05-29 | 88 | 0 |
| K191499 | MAGLUMI 2000 25-OH Vitamin D | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2019-08-01 | 56 | 0 |
| K180577 | BioPlex 2200 25-OH Vitamin D Kit | Bio-Rad Laboratories | 2018-06-22 | 109 | 0 |
| K172992 | Diazyme EZ Vitamin D Assay | Diazyme Laboratories | 2018-01-11 | 106 | 0 |
| K162298 | LOCI Total Vitamin D Total Assay, LOCI VITD CAL | Siemens Healthcare Diagnostics | 2017-03-16 | 212 | 0 |
| K162840 | Elecsys Vitamin D total II, Vitamin D total II CalSet, Preci | Roche Diagnostics | 2017-02-08 | 120 | 0 |
| K162754 | FREND Vitamin D Test System | Nanoentek USA, Inc. | 2017-01-12 | 104 | 0 |
| K161831 | IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set | Immunodiagnostic Systems , Ltd. | 2016-11-15 | 133 | 0 |
| K153375 | ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P | Abbott Laboratories | 2016-08-12 | 263 | 0 |
| K153361 | Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Cal | Fujirebio Diagnostics,Inc. | 2016-04-15 | 147 | 0 |
| K150270 | ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Cal | Tosoh Bioscience, Inc. | 2015-10-26 | 264 | 0 |
| K142351 | 25-Hydroxy Vitamin Ds EIA | Immunodiagnostic Systems , Ltd. | 2015-08-25 | 368 | 0 |
| K141114 | BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH V | Bio-Rad Laboratories | 2015-01-09 | 254 | 0 |
| K142373 | Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno | Beckman Coulter, Inc. | 2014-12-22 | 119 | 0 |
| K140554 | IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITA | Immunodiagnostic Systems , Ltd. | 2014-12-19 | 290 | 0 |
| K142362 | Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immu | Beckman Coulter, Inc. | 2014-12-19 | 116 | 0 |
| K141463 | LIASON XL1,25 DIHYDROXYVITAMIN D; CONTROL SET, CALIBRATION V | DiaSorin, Inc. | 2014-12-10 | 190 | 0 |
| K133156 | ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY;ADVIA CENTAUR VIT | Siemens Healthcare Diagnostics, Inc. | 2014-07-24 | 280 | 0 |
| K133410 | DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTR | Diazyme Laboratories | 2014-03-14 | 127 | 0 |
| K132492 | LIAISON 25 TOTAL-D | DiaSorin, Inc. | 2013-09-05 | 27 | 0 |
| K123660 | 25-OH VITAMIN D ELISA | Euroimmun US | 2013-07-17 | 231 | 0 |
| K123364 | 25OH VITAMIN D TOTAL ELISA TEST | Diasource Immunoassays, S.A. | 2013-07-15 | 256 | 0 |
| K123983 | FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERI | Qualigen, Inc. | 2013-07-03 | 189 | 1 |
| K123253 | IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY | Immunodiagnostic Systems , Ltd. | 2013-06-18 | 244 | 0 |
| K121608 | VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGE | Ortho-Clinical Diagnostics, Inc. | 2013-02-15 | 259 | 1 |
| K123131 | ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CAL | Tosoh Bioscience, Inc. | 2013-02-08 | 127 | 0 |
| K122420 | DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITA | Diazyme Laboratories | 2012-11-28 | 111 | 0 |
| K113546 | ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRE | Roche Diagnostics | 2012-07-24 | 236 | 0 |
| K112725 | LIAISON 25 OH VITAMIN D TOTAL ASSAY | DiaSorin, Inc. | 2012-01-20 | 122 | 0 |
| K110619 | ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CA | Biokit, S.A. | 2011-11-23 | 265 | 1 |
| K110586 | ADVIA CENTAUR VITAMIN D TOTAL ASSAY | Siemens Healthcare Diagnostics, Inc. | 2011-10-14 | 227 | 5 |
| K102432 | DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME | Diazyme Laboratories | 2011-01-14 | 141 | 0 |
| K091849 | IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VIT | Immunodiagnostic Systems, Inc. | 2010-06-25 | 368 | 0 |
| K072536 | ESA BIOSCIENCES INC. VITAMIN D HPLC TEST | Esa Biosciences, Inc. | 2008-05-07 | 243 | 0 |
| K071480 | LIAISON 25 OH VITAMIN D TOTAL; ASSAY, CONTROL SET AND SPECIM | DiaSorin, Inc. | 2007-10-01 | 125 | 0 |
| K051110 | 1,25-DIHYDROXY VITAMIN D EIA | Immunodiagnostic Systems , Ltd. | 2005-07-06 | 65 | 0 |
| K042519 | GAMMA-B 1,25-DIHYDROXY VITAMIN D | Immunodiagnostic Systems , Ltd. | 2004-12-01 | 76 | 0 |
| K032844 | LIAISON 25 OH VITAMIN D | DiaSorin, Inc. | 2004-02-12 | 154 | 4 |
| K021163 | OCTEIA 25-HYDROXY VITAMIN D | Immunodiagnostic Systems , Ltd. | 2002-05-10 | 29 | 2 |
| K014030 | 1,25-DIHYDROXYVITAMIN D125I RIA | DiaSorin, Inc. | 2002-03-26 | 110 | 1 |
| K991998 | GAMMA-B 25-HYDROXY VITAMIN D RIA | Immunodiagnostic Systems , Ltd. | 1999-09-17 | 95 | 0 |
| K953567 | INCSTAR 25-HYDROXYVITMIN D 1251 RIA | Incstar Corp. | 1996-09-25 | 422 | 1 |
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