MRG · System, Test, Vitamin D
Clinical Chemistry · 21 CFR 862.1825 · Class 2
Overview
| Product Code | MRG |
|---|---|
| Device Name | System, Test, Vitamin D |
| Regulation | 21 CFR 862.1825 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A vitamin D test system is a device intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency.
Classification Rationale
Class II (special controls). Vitamin D test systems must comply with the following special controls:
Special Controls
*Classification.* Class II (special controls). Vitamin D test systems must comply with the following special controls:(1) Labeling in conformance with 21 CFR 809.10 and (2) Compliance with existing standards of the National Committee on Clinical Laboratory Standards.
Recent Cleared Devices (20 of 46)
Showing 20 most recent of 46 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K232587 | MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer | Shenzhen New Industries Biomedical Engineering Co., Ltd. | Apr 12, 2024 | SESE |
| K221817 | ALFIS Vitamin D, ALFIS-3 Analyzer | Immunostics Inc., | Sep 22, 2023 | SESE |
| K223503 | Access 25(OH) Vitamin D Total | Beckman Coulter, Inc. | Jan 19, 2023 | SESE |
| K210901 | Elecsys Vitamin D total III | Roche Diagnostics | Sep 1, 2021 | SESE |
| K200509 | ADVIA Centaur Vitamin D Total (VitD) | Siemens Healthcare Diagnostics, Inc. | May 29, 2020 | SESE |
| K191499 | MAGLUMI 2000 25-OH Vitamin D | Shenzhen New Industries Biomedical Engineering Co., Ltd. | Aug 1, 2019 | SESE |
| K180577 | BioPlex 2200 25-OH Vitamin D Kit | Bio-Rad Laboratories | Jun 22, 2018 | SESE |
| K172992 | Diazyme EZ Vitamin D Assay | Diazyme Laboratories | Jan 11, 2018 | SESE |
| K162298 | LOCI Total Vitamin D Total Assay, LOCI VITD CAL | Siemens Healthcare Diagnostics | Mar 16, 2017 | SESE |
| K162840 | Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 | Roche Diagnostics | Feb 8, 2017 | SESE |
| K162754 | FREND Vitamin D Test System | Nanoentek USA, Inc. | Jan 12, 2017 | SESE |
| K161831 | IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set | Immunodiagnostic Systems , Ltd. | Nov 15, 2016 | SESE |
| K153375 | ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls | Abbott Laboratories | Aug 12, 2016 | SESE |
| K153361 | Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators | Fujirebio Diagnostics,Inc. | Apr 15, 2016 | SESE |
| K150270 | ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set | Tosoh Bioscience, Inc. | Oct 26, 2015 | SESE |
| K142351 | 25-Hydroxy Vitamin Ds EIA | Immunodiagnostic Systems , Ltd. | Aug 25, 2015 | SESE |
| K141114 | BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D | Bio-Rad Laboratories | Jan 9, 2015 | SESE |
| K142373 | Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst | Beckman Coulter, Inc. | Dec 22, 2014 | SESE |
| K142362 | Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno. | Beckman Coulter, Inc. | Dec 19, 2014 | SESE |
| K140554 | IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET | Immunodiagnostic Systems , Ltd. | Dec 19, 2014 | SESE |
Top Applicants
- Immunodiagnostic Systems , Ltd. — 8 clearances
- DiaSorin, Inc. — 6 clearances
- Diazyme Laboratories — 4 clearances
- Siemens Healthcare Diagnostics, Inc. — 3 clearances
- Roche Diagnostics — 3 clearances
