Elecsys proBNP II, Elecsys proBNP II STAT
FDA 510(k) K223637 · Roche Diagnostics
510(k) numberK223637
Submission
- Device name
- Elecsys proBNP II, Elecsys proBNP II STAT
- Applicant
- Roche Diagnostics
Indianapolis, IN, US - Received
- December 5, 2022
- Decision date
- July 21, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NBC – Test, Natriuretic Peptide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1117
- Specialty
- Clinical Chemistry
Other 510(k)s with product code NBC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252169 | Access BNP IINBC · Traditional | Beckman Coulter, Inc. | 03/24/2026SE |
| K253539 | Alere NT-proBNP for Alinity iNBC · Traditional | Axis-Shield Diagnostics, Ltd. | 02/18/2026SE |
| K241176 | Alere NT-proBNP for Alinity i Reagent KitNBC · Traditional | Axis-Shield Diagnostics, Ltd. | 01/16/2025SE |
| K232164 | Access NT-proBNPNBC · Traditional | Beckman Coulter, Inc. | 04/12/2024SE |
| K220265 | ADVIA Centaur® NT-proBNPII (PBNPII)NBC · Traditional | Siemens Healthcare Diagnostics, Inc. | 09/24/2023SE |
| K210546 | Elecsys proBNP II, Elecsys proBNP II STATNBC · Traditional | Roche Diagnostics | 03/31/2022SE |
| K211199 | ST AIA-PACK BNP AssayNBC · Special | Tosoh Bioscience, Inc. | 11/08/2021SE |
| K201312 | VITROS Immunodiagnostic Products NT-proBNP II Reagent PackNBC · Traditional | Ortho Clinical Diagnostics | 10/04/2021SE |
| K192380 | ST Aia-Pack BNPNBC · Traditional | Fujirebio Diagnostics,Inc. | 08/24/2020SE |
| K092649 | Elecsys Probnp II Stat Immunoassay and Elecsys Probnp II Calset, Models 05390109-160…NBC · Special | Roche Diagnostics Corp. | 02/04/2010SE |
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Questions and answers
When was Elecsys proBNP II, Elecsys proBNP II STAT cleared by the FDA?
Elecsys proBNP II, Elecsys proBNP II STAT (K223637) received a 510(k) decision of Substantially Equivalent on July 21, 2023, 228 days after the submission was received.
What is the product code of K223637?
The FDA product code is NBC – Test, Natriuretic Peptide, a Class II (moderate risk) device regulated under 21 CFR 862.1117.