VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack
FDA 510(k) K201312 · Ortho Clinical Diagnostics
510(k) numberK201312
Submission
- Device name
- VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack
- Applicant
- Ortho Clinical Diagnostics
Rochester, NY, US - Received
- May 18, 2020
- Decision date
- October 4, 2021
- 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
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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 |
| 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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| 510(k) | Device | Decision |
|---|---|---|
| K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent PackMMI · Traditional | 10/29/2025SE |
| K241534 | VITROS Immunodiagnostic Products Syphilis Reagent PackLIP · Traditional | 08/28/2024SE |
| K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackDHA · Traditional | 05/08/2024SE |
| K221197 | VITROS Immunodiagnostic Products Intact PTH II Reagent PackCEW · Traditional | 09/05/2023SE |
| K231517 | VITROS Immunodiagnostic Products CEA Reagent PackDHX · Traditional | 08/23/2023SE |
| K231525 | VITROS Immunodiagnostic Products CA 19-9TM Reagent PackNIG · Traditional | 08/09/2023SE |
| K221355 | VITROS Immuodiagnostic Products CA 125 II Reagent PackLTK · Traditional | 12/12/2022SE |
| K213626 | Vitros AfpLOJ · Traditional | 06/15/2022SE |
| K212648 | VITROS Immunodiagnostic Products CK-MB Reagent PackJHX · Traditional | 01/28/2022SE |
| K210858 | VITROS Chemistry Products PHBR SlidesDLZ · Traditional | 08/13/2021SE |
Questions and answers
When was VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack cleared by the FDA?
VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack (K201312) received a 510(k) decision of Substantially Equivalent on October 4, 2021, 504 days after the submission was received.
What is the product code of K201312?
The FDA product code is NBC – Test, Natriuretic Peptide, a Class II (moderate risk) device regulated under 21 CFR 862.1117.