CardioPhase® hsCRP
FDA 510(k) K212559 · Siemens Healthcare Diagnostics Products GmbH
510(k) numberK212559
Submission
- Device name
- CardioPhase® hsCRP
- Applicant
- Siemens Healthcare Diagnostics Products GmbH
Marburg, DE - Received
- August 13, 2021
- Decision date
- December 16, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NQD – Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5270
- Specialty
- Immunology
In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments.
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|---|---|---|---|
| K260026 | Tina-quant Cardiac high sensitivity CRP IIINQD · Traditional | Roche Diagnostics | 04/02/2026SE |
| K233242 | Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)NQD · Traditional | Siemens Healthcare Diagnostics, Inc. | 01/18/2024SE |
| K173833 | CRP VarioNQD · Traditional | SENTINEL CH. SpA | 09/27/2018SE |
| K081294 | Advia Chemistry Cardiophase High Sensitivity C-Reactive Protein (Hscrp), CalibratorsNQD · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/29/2008SE |
| K071002 | Immage Immunochemistry Systems High Sensitivity Cardiac C-Reactive Protein (CCRP) ReagentNQD · Traditional | Beckman Coulter, Inc. | 06/21/2007SE |
| K070626 | Synchron Systems High Sensitivity Cardiac C-Reactive Protein (CRPH) ReagentNQD · Traditional | Beckman Coulter, Inc. | 05/04/2007SE |
| K071017 | Immulite 2500 High Sensitivity C-Reactive Protein, Models L5KCRP (200 Tests), L5KCRP…NQD · Special | Siemens Medical Solutions Diagnostics | 05/02/2007SE |
| K062924 | Stratus CS Acute Care Cardiophase Hscrp TestpakNQD · Traditional | Dade Behring, Inc. | 12/26/2006SE |
| K063057 | Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRPNQD · Abbreviated | Diagnostic Products Corporation | 12/22/2006SE |
| K061802 | Dimension Vista Cardiophase Hscrp Flex Reagent Cartridge, Protein 2 Calibrator, Hscrp…NQD · Traditional | Dade Behring, Inc. | 09/11/2006SE |
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Questions and answers
When was CardioPhase® hsCRP cleared by the FDA?
CardioPhase® hsCRP (K212559) received a 510(k) decision of Substantially Equivalent on December 16, 2022, 490 days after the submission was received.
What is the product code of K212559?
The FDA product code is NQD – Cardiac C-Reactive Protein, Antigen, Antiserum, And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5270.