Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1825](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1825) → MRG — System, Test, Vitamin D # MRG · System, Test, Vitamin D _Clinical Chemistry · 21 CFR 862.1825 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRG ## Overview - **Product Code:** MRG - **Device Name:** System, Test, Vitamin D - **Regulation:** [21 CFR 862.1825](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1825) - **Device Class:** 2 - **Review Panel:** [Clinical Chemistry](/submissions/CH) - **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](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRG/K232587.md) | MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer | Shenzhen New Industries Biomedical Engineering Co., Ltd. | Apr 12, 2024 | SESE | | [K221817](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRG/K221817.md) | ALFIS Vitamin D, ALFIS-3 Analyzer | Immunostics Inc., | Sep 22, 2023 | SESE | | [K223503](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRG/K223503.md) | Access 25(OH) Vitamin D Total | Beckman Coulter, Inc. | Jan 19, 2023 | SESE | | [K210901](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRG/K210901.md) | Elecsys Vitamin D total III | Roche Diagnostics | Sep 1, 2021 | SESE | | [K200509](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRG/K200509.md) | ADVIA Centaur Vitamin D Total (VitD) | Siemens Healthcare Diagnostics, Inc. | May 29, 2020 | SESE | | [K191499](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRG/K191499.md) | MAGLUMI 2000 25-OH Vitamin D | Shenzhen New Industries Biomedical Engineering Co., Ltd. | Aug 1, 2019 | SESE | | [K180577](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRG/K180577.md) | BioPlex 2200 25-OH Vitamin D Kit | Bio-Rad Laboratories | Jun 22, 2018 | SESE | | [K172992](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRG/K172992.md) | Diazyme EZ Vitamin D Assay | Diazyme Laboratories | Jan 11, 2018 | SESE | | [K162298](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRG/K162298.md) | LOCI Total Vitamin D Total Assay, LOCI VITD CAL | Siemens Healthcare Diagnostics | Mar 16, 2017 | SESE | | [K162840](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRG/K162840.md) | 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](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRG/K162754.md) | FREND Vitamin D Test System | Nanoentek USA, Inc. | Jan 12, 2017 | SESE | | [K161831](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRG/K161831.md) | IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set | Immunodiagnostic Systems , Ltd. | Nov 15, 2016 | SESE | | [K153375](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRG/K153375.md) | 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](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRG/K153361.md) | Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators | Fujirebio Diagnostics,Inc. | Apr 15, 2016 | SESE | | [K150270](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRG/K150270.md) | 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](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRG/K142351.md) | 25-Hydroxy Vitamin Ds EIA | Immunodiagnostic Systems , Ltd. | Aug 25, 2015 | SESE | | [K141114](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRG/K141114.md) | 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](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRG/K142373.md) | 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](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRG/K142362.md) | 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](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRG/K140554.md) | 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 - Beckman Coulter, Inc. — 3 clearances - Roche Diagnostics — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRG](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MRG) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com