ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)
FDA 510(k) K160757 · Axis-Shield Diagnostics Limited
510(k) numberK160757
Submission
- Device name
- ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)
- Applicant
- Axis-Shield Diagnostics Limited
Dundee, Scotland, GB - Received
- March 18, 2016
- Decision date
- July 26, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CDD – Radioassay, Vitamin B12
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1810
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CDD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233541 | ARCHITECT Active-B12 (Holotranscobalamin)CDD · Traditional | Axis-Shield Diagnostics, Ltd. | 07/31/2024SE |
| K223289 | Access Vitamin B12CDD · Traditional | Beckman Coulter, Inc. | 12/23/2022SE |
| K190298 | DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH…CDD · Traditional | Beckman Coulter Biomedical GmbH | 10/04/2019SE |
| K192064 | LIAISON Vitamin B12CDD · Traditional | DiaSorin, Inc. | 10/02/2019SE |
| K172133 | ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayCDD · Special | Axis-Shield Diagnostics, Ltd. | 10/27/2017SE |
| K161721 | Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12…CDD · Traditional | Diazyme Laboratories | 09/20/2016SE |
| K151786 | Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSetCDD · Traditional | Roche Diagnostics | 09/24/2015SE |
| K140496 | Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access…CDD · Special | Beckman Coulter, Inc. | 09/16/2014SE |
| K133512 | Loci Vitamin B12 (VB12) Flex Reagent Cartridge, Loci Anemia Calibrator (Anem Cal)CDD · Traditional | Siemens Healthcare Diagnostics | 01/02/2014SE |
| K121946 | Axis-Shield ACVTIVE-B12CDD · Traditional | Axis-Shield Diagnostics, Ltd. | 03/22/2013SE |
More from Axis-Shield Diagnostics, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253539 | Alere NT-proBNP for Alinity iNBC · Traditional | 02/18/2026SE |
| K241176 | Alere NT-proBNP for Alinity i Reagent KitNBC · Traditional | 01/16/2025SE |
| K233541 | ARCHITECT Active-B12 (Holotranscobalamin)CDD · Traditional | 07/31/2024SE |
| K183088 | ADVIA Centaur Erythropoietin (EPO) assayGGT · Traditional | 08/02/2019SE |
| K182012 | ADVIA Centaur Calcitonin (CALCT) assayJKR · Traditional | 12/21/2018SE |
| K172133 | ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayCDD · Special | 10/27/2017SE |
| K153551 | ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality…NHX · Traditional | 08/04/2016SE |
| K121946 | Axis-Shield ACVTIVE-B12CDD · Traditional | 03/22/2013SE |
| K121842 | Architect HBA1C, Architect HBA1C, and Architect HBA1CLCP · Traditional | 12/12/2012SE |
| K112790 | Axis-Shield 3-REAGENT Homocysteine Assay for SynchronLPS · Traditional | 05/07/2012SE |
Questions and answers
When was ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) cleared by the FDA?
ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) (K160757) received a 510(k) decision of Substantially Equivalent on July 26, 2016, 130 days after the submission was received.
What is the product code of K160757?
The FDA product code is CDD – Radioassay, Vitamin B12, a Class II (moderate risk) device regulated under 21 CFR 862.1810.