ADVIA Centaur Calcitonin (CALCT) assay
FDA 510(k) K182012 · Axis-Shield Diagnostics Limited
510(k) numberK182012
Submission
- Device name
- ADVIA Centaur Calcitonin (CALCT) assay
- Applicant
- Axis-Shield Diagnostics Limited
Dundee, GB - Received
- July 27, 2018
- Decision date
- December 21, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JKR – Radioimmunoassay, Calcitonin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1140
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JKR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252431 | Elecsys CalcitoninJKR · Traditional | Roche Diagnostics GmbH | 04/24/2026SE |
| K132828 | Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3JKR · Traditional | Roche Diagnostics | 12/04/2013SE |
| K060578 | Calcitonin Immunoradiometric Assay (Irma) (Coated Tube Version)JKR · Traditional | Scantibodies Laboratory, Inc. | 08/30/2006SE |
| K023304 | Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCLJKR · Traditional | Diagnostic Products Corp. | 12/09/2002SE |
| K990073 | CalcitoninJKR · Traditional | Kmi Diagnostics, Inc. | 05/11/1999SE |
| K982491 | Sangui Biotech, Inc. Calcitonin Elisa KitJKR · Traditional | Sangui Biotech, Inc. | 09/03/1998SE |
| K964635 | Nichols Advantage Chemiluminescence Calcitonin KitJKR · Traditional | Nichols Institute Diagnostics | 05/21/1997SE |
| K961043 | Scantibodies Calcitonin Immunoradiometric Assay (Coated Bead Technology)JKR · Traditional | Scantibodies Laboratory, Inc. | 05/06/1996SE |
| K945961 | Calcitonin Immunoassay KitJKR · Traditional | Nichols Institute Diagnostics | 11/20/1995SE |
| K951708 | Elsa-HctJKR · Traditional | Cis-Us, Inc. | 09/05/1995SE |
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| K153551 | ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality…NHX · Traditional | 08/04/2016SE |
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Questions and answers
When was ADVIA Centaur Calcitonin (CALCT) assay cleared by the FDA?
ADVIA Centaur Calcitonin (CALCT) assay (K182012) received a 510(k) decision of Substantially Equivalent on December 21, 2018, 147 days after the submission was received.
What is the product code of K182012?
The FDA product code is JKR – Radioimmunoassay, Calcitonin, a Class II (moderate risk) device regulated under 21 CFR 862.1140.