I-Stat B-Type Natriuretic Peptide (BNP)
FDA 510(k) K053597 · I-Stat Corporation
510(k) numberK053597
Submission
- Device name
- I-Stat B-Type Natriuretic Peptide (BNP)
- Applicant
- I-Stat Corporation
East Windsor, NJ, US - Received
- December 23, 2005
- Decision date
- July 21, 2006
- 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
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|---|---|---|---|
| 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 |
| K223637 | Elecsys proBNP II, Elecsys proBNP II STATNBC · Traditional | Roche Diagnostics | 07/21/2023SE |
| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K053110 | Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge…JGS · Special | 01/13/2006SE |
| K051433 | I-Stat Creatine Kinase MB (Ck-Mb)MYT · Traditional | 12/15/2005SE |
| K031873 | I-Stat Cardiac Markers Control Level 1, 2, and 3; Cardiac Markers Calibration…JJX · Traditional | 10/07/2003SE |
| K023582 | I-Stat Kaolin Act TestJBP · Traditional | 09/08/2003SE |
| K031739 | I-Stat Cardiac Troponin (Ctni) TestMMI · Traditional | 09/02/2003SE |
| K020355 | I-Stat Prothrombin Time TestGJS · Traditional | 05/14/2002SE |
| K012478 | Modification to: I-Stat Portable Clinical AnalyzerCHL · Special | 08/20/2001SE |
| K011478 | I-Stat SystemKHP · Traditional | 07/02/2001SE |
| K001387 | I-Stat Portable Clinical Analyzer, Model 300CGA · Traditional | 10/05/2000SE |
| K001154 | I-Stat Model 200 Portable Clinical AnalyzerJGS · Special | 04/18/2000SE |
Questions and answers
When was I-Stat B-Type Natriuretic Peptide (BNP) cleared by the FDA?
I-Stat B-Type Natriuretic Peptide (BNP) (K053597) received a 510(k) decision of Substantially Equivalent on July 21, 2006, 210 days after the submission was received.
What is the product code of K053597?
The FDA product code is NBC – Test, Natriuretic Peptide, a Class II (moderate risk) device regulated under 21 CFR 862.1117.