CDD · Radioassay, Vitamin B12
Clinical Chemistry · 21 CFR 862.1810 · Class 2
Overview
| Product Code | CDD |
|---|---|
| Device Name | Radioassay, Vitamin B12 |
| Regulation | 21 CFR 862.1810 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 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 | ARCHITECT Active-B12 (Holotranscobalamin) | Axis-Shield Diagnostics, Ltd. | Jul 31, 2024 | SESE |
| K223289 | Access Vitamin B12 | Beckman Coulter, Inc. | Dec 23, 2022 | SESE |
| K190298 | 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 | LIAISON Vitamin B12 | DiaSorin, Inc. | Oct 2, 2019 | SESE |
| K172133 | ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay | Axis-Shield Diagnostics, Ltd. | Oct 27, 2017 | SESE |
| K161721 | Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set | Diazyme Laboratories | Sep 20, 2016 | SESE |
| K160757 | 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 | Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet | Roche Diagnostics | Sep 24, 2015 | SESE |
| K140496 | 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 | LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL) | Siemens Healthcare Diagnostics | Jan 2, 2014 | SESE |
| K121946 | AXIS-SHIELD ACVTIVE-B12 | Axis-Shield Diagnostics, Ltd. | Mar 22, 2013 | SESE |
| K121994 | DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR | Siemens Healthcare Diagnostics, Inc. | Nov 30, 2012 | SESE |
| K111260 | A/C ENZYMATIC VITAMIN B6 ASSAY | Anticancer, Inc. | Jul 26, 2012 | SESE |
| K121314 | ARCHITECT B12 | Abbott Laboratories | May 17, 2012 | SESE |
| K112443 | ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) | Axis-Shield Diagnostics, Ltd. | Dec 19, 2011 | SESE |
| K110579 | ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS | Abbott Laboratories | Oct 6, 2011 | SESE |
| K110413 | POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS | Beckman Coulter, Inc. | May 11, 2011 | SESE |
| K093631 | B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644 | Siemens Healthcare Diagnostics | Feb 12, 2010 | SESE |
| K090588 | POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210 | Beckman Coulter, Inc. | May 27, 2009 | SESE |
| K071224 | 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
