Elecsys Calcitonin
FDA 510(k) K252431 · Roche Diagnostics GmbH
510(k) numberK252431
Submission
- Device name
- Elecsys Calcitonin
- Applicant
- Roche Diagnostics GmbH
Mannheim, DE - Received
- August 1, 2025
- Decision date
- April 24, 2026
- 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 |
|---|---|---|---|
| K182012 | ADVIA Centaur Calcitonin (CALCT) assayJKR · Traditional | Axis-Shield Diagnostics Limited | 12/21/2018SE |
| 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 |
More from Cis-Us, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261686 | Elecsys Phospho-Tau (217P) PlasmaSET · Traditional | 08/19/2026SE |
| K252323 | cobas pulse blood glucose monitoring systemPZI · Dual Track | 06/12/2026SE |
| K252280 | Elecsys Anti-SARS-CoV-2 SQVP · Traditional | 04/13/2026SE |
| K260049 | Elecsys Anti-HBc IgMSEI · Traditional | 04/07/2026SE |
| K260048 | Elecsys Anti-HAV IgMLOL · Traditional | 04/07/2026SE |
| K260046 | Elecsys Anti-HBc IISEI · Traditional | 04/07/2026SE |
| K260026 | Tina-quant Cardiac high sensitivity CRP IIINQD · Traditional | 04/02/2026SE |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…CEM · Traditional | 02/12/2026SE |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsCFR · Traditional | 02/12/2026SE |
| K253839 | Elecsys Anti-SARS-CoV-2QVP · Special | 12/17/2025SE |
Questions and answers
When was Elecsys Calcitonin cleared by the FDA?
Elecsys Calcitonin (K252431) received a 510(k) decision of Substantially Equivalent on April 24, 2026, 266 days after the submission was received.
What is the product code of K252431?
The FDA product code is JKR – Radioimmunoassay, Calcitonin, a Class II (moderate risk) device regulated under 21 CFR 862.1140.