Synchron Systems C-Reactive Protein (C-RP) Reagent; Synchron Systems CX C-RP Calibrator
510(k) K021572
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK021572 | Date19 Jul 2002 | StatusActive |
| European Union | CE/IVDD EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- DCN
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5270
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Synchron Systems C-Reactive Protein (C-RP) Reagent and Synchron Systems CX C-RP Calibrator are in vitro diagnostic devices designed for the quantitative measurement of C-reactive protein in human serum or plasma. C-reactive protein is a biomarker used to detect inflammation, infection, or tissue injury, and these reagents enable precise clinical assessment in laboratory settings.
These devices are intended for use with the Synchron Systems chemistry analyzer, supplied as sterile, single-use reagents and calibrators. The reagents and calibrator are classified as Class II devices under FDA regulations (510(k) clearance) and comply with the In Vitro Diagnostic Device Directive (IVDD). Storage and handling follow manufacturer guidelines to maintain accuracy and reliability, ensuring proper diagnostic performance in clinical immunology applications.
Other devices from Beckman Coulter, Inc.
Questions
AI-generated answers, 18 Sep 2026
What clinical applications does the Synchron Systems C-Reactive Protein (C-RP) Reagent support in a lab setting?
The Synchron Systems C-Reactive Protein (C-RP) Reagent is designed for the quantitative measurement of C-reactive protein in human serum or plasma. Clinically, this biomarker helps detect inflammation, infection, or tissue injury, enabling precise diagnostic assessments in laboratory settings. It is specifically intended for use with the Synchron Systems chemistry analyzer to support clinical immunology applications.
Are the Synchron Systems C-RP Reagent and CX C-RP Calibrator single-use or reusable, and how should they be stored?
Both the Synchron Systems C-Reactive Protein (C-RP) Reagent and the Synchron Systems CX C-RP Calibrator are supplied as sterile, single-use items. To maintain accuracy and reliability, they must be stored and handled according to the manufacturer’s guidelines, which ensure proper diagnostic performance.
What analyzer is required to use the Synchron Systems C-Reactive Protein (C-RP) Reagent, and is it compatible with other systems?
The Synchron Systems C-Reactive Protein (C-RP) Reagent is explicitly designed for use with the Synchron Systems chemistry analyzer. It is not intended for use with other systems, as compatibility and performance are validated only for this specific analyzer.
What regulatory pathways have the Synchron Systems C-Reactive Protein (C-RP) Reagent and CX C-RP Calibrator undergone?
The device has received FDA 510(k) clearance and complies with the In Vitro Diagnostic Device Directive (IVDD). It is classified as a Class II device under FDA regulations, with a substantially equivalent determination by the Immunology (IM) Advisory Committee. The product was filed under the DCN product code and reviewed by the same committee.