CRP Vario
FDA 510(k) K173833 · SENTINEL CH. SpA
510(k) numberK173833
Submission
- Device name
- CRP Vario
- Applicant
- SENTINEL CH. SpA
Milano, IT - Received
- December 18, 2017
- Decision date
- September 27, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K212559 | CardioPhase® hsCRPNQD · Special | Siemens Healthcare Diagnostics Products GmbH | 12/16/2022SE |
| 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 |
More from Dade Behring, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K242585 | Cystatin CNDY · Traditional | 05/16/2025SE |
| K211058 | Lp(a) UltraDFC · Traditional | 12/22/2022SE |
| K193001 | Albumin BCPCJW · Traditional | 12/19/2019SE |
| K192118 | CRP VarioDCK · Special | 11/08/2019SE |
| K141728 | Ace CalibratorJIT · Abbreviated | 07/28/2014SE |
| K102706 | CKMB Udr AssayJHS · Traditional | 08/19/2011SE |
| K083602 | Kappa Light ChainsDFH · Traditional | 09/03/2009SE |
| K083601 | Lambda Light ChainsDEH · Traditional | 06/22/2009SE |
| K081533 | Sentinel Plasmaproteins Cal 3XJIX · Traditional | 06/25/2008SE |
| K073634 | Multigent Creatinine (Enzymatic) AssayJFY · Traditional | 06/19/2008SE |
Questions and answers
When was CRP Vario cleared by the FDA?
CRP Vario (K173833) received a 510(k) decision of Substantially Equivalent on September 27, 2018, 283 days after the submission was received.
What is the product code of K173833?
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.