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 862.1810](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1810) → CDD — Radioassay, Vitamin B12 # CDD · Radioassay, Vitamin B12 _Clinical Chemistry · 21 CFR 862.1810 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD ## Overview - **Product Code:** CDD - **Device Name:** Radioassay, Vitamin B12 - **Regulation:** [21 CFR 862.1810](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1810) - **Device Class:** 2 - **Review Panel:** [Clinical Chemistry](/submissions/CH) - **3rd-party reviewable:** yes ## Identification A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 78) Showing 20 most recent of 78 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K233541](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K233541.md) | ARCHITECT Active-B12 (Holotranscobalamin) | Axis-Shield Diagnostics, Ltd. | Jul 31, 2024 | SESE | | [K223289](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K223289.md) | Access Vitamin B12 | Beckman Coulter, Inc. | Dec 23, 2022 | SESE | | [K190298](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K190298.md) | DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 | Beckman Coulter Biomedical GmbH | Oct 4, 2019 | SESE | | [K192064](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K192064.md) | LIAISON Vitamin B12 | DiaSorin, Inc. | Oct 2, 2019 | SESE | | [K172133](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K172133.md) | ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay | Axis-Shield Diagnostics, Ltd. | Oct 27, 2017 | SESE | | [K161721](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K161721.md) | Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set | Diazyme Laboratories | Sep 20, 2016 | SESE | | [K160757](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K160757.md) | ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) | Axis-Shield Diagnostics Limited | Jul 26, 2016 | SESE | | [K151786](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K151786.md) | Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet | Roche Diagnostics | Sep 24, 2015 | SESE | | [K140496](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K140496.md) | Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents | Beckman Coulter, Inc. | Sep 16, 2014 | SESE | | [K133512](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K133512.md) | LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL) | Siemens Healthcare Diagnostics | Jan 2, 2014 | SESE | | [K121946](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K121946.md) | AXIS-SHIELD ACVTIVE-B12 | Axis-Shield Diagnostics, Ltd. | Mar 22, 2013 | SESE | | [K121994](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K121994.md) | DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR | Siemens Healthcare Diagnostics, Inc. | Nov 30, 2012 | SESE | | [K111260](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K111260.md) | A/C ENZYMATIC VITAMIN B6 ASSAY | Anticancer, Inc. | Jul 26, 2012 | SESE | | [K121314](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K121314.md) | ARCHITECT B12 | Abbott Laboratories | May 17, 2012 | SESE | | [K112443](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K112443.md) | ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) | Axis-Shield Diagnostics, Ltd. | Dec 19, 2011 | SESE | | [K110579](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K110579.md) | ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS | Abbott Laboratories | Oct 6, 2011 | SESE | | [K110413](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K110413.md) | POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS | Beckman Coulter, Inc. | May 11, 2011 | SESE | | [K093631](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K093631.md) | B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644 | Siemens Healthcare Diagnostics | Feb 12, 2010 | SESE | | [K090588](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K090588.md) | POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210 | Beckman Coulter, Inc. | May 27, 2009 | SESE | | [K071224](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K071224.md) | DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR | Dade Behring, Inc. | Nov 13, 2007 | SESE | ## Top Applicants - Axis-Shield Diagnostics, Ltd. — 5 clearances - Diagnostic Products Corp. — 5 clearances - Abbott Laboratories — 4 clearances - Beckman Coulter, Inc. — 4 clearances - Ciba Corning Diagnostics Corp. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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