Elecsys CA 15-3 II
FDA 510(k) K171605 · Roche Diagnostics
510(k) numberK171605
Submission
- Device name
- Elecsys CA 15-3 II
- Applicant
- Roche Diagnostics
Indianapolis, IN, US - Received
- June 1, 2017
- Decision date
- February 20, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MOI – System, Test, Immunological, Antigen, Tumor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6010
- Specialty
- Immunology
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|---|---|---|---|
| K240403 | Access BR MonitorMOI · Traditional | Beckman Coulter, Inc. | 05/09/2024SE |
| K233946 | Immulite® 2000 Br-MaMOI · Traditional | Siemens Healthcare Diagnostics Products, Ltd. | 03/13/2024SE |
| K192524 | Lumipulse G CA15-3MOI · Traditional | Fujirebio Diagnostics,Inc. | 09/04/2020SE |
| K193489 | ADVIA Centaur BRMOI · Traditional | Siemens Healthcare Diagnostics, Inc. | 02/13/2020SE |
| K192777 | ADVIA Centaur CA 15-3 assayMOI · Traditional | Siemens Healthcare Diagnostics, Inc. | 11/22/2019SE |
| K181492 | Elecsys CA 15-3 IIMOI · Traditional | Roche Diagnostics | 06/22/2018SE |
| K100344 | Dimension Vista Loci Ca 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7 Calibrator…MOI · Traditional | Siemens Healthcare Diagnostics | 04/18/2011SE |
| K072612 | Access Immunoassay Systems BR Monitor, and Calibrators, Model(S) 387620,AND 387647MOI · Special | Beckman Coulter, Inc. | 10/26/2007SE |
| K042732 | Architect Ca 15-3 AssayMOI · Traditional | Fujirebio Diagnostics,Inc. | 12/22/2004SE |
| K033036 | BR Monitor and BR Monitor Calibrators on the Access Immunoassay Systems, Model 387620…MOI · Traditional | Beckman Coulter, Inc. | 02/03/2004SE |
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| 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 |
| K252431 | Elecsys CalcitoninJKR · Traditional | 04/24/2026SE |
| 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 |
Questions and answers
When was Elecsys CA 15-3 II cleared by the FDA?
Elecsys CA 15-3 II (K171605) received a 510(k) decision of Substantially Equivalent on February 20, 2018, 264 days after the submission was received.
What is the product code of K171605?
The FDA product code is MOI – System, Test, Immunological, Antigen, Tumor, a Class II (moderate risk) device regulated under 21 CFR 866.6010.