CardioPhase® hsCRP

K212559 · Siemens Healthcare Diagnostics Products GmbH · NQD · Dec 16, 2022 · Immunology

Device Facts

• Record ID: K212559
• Device Name: CardioPhase® hsCRP
• Applicant: Siemens Healthcare Diagnostics Products GmbH
• Product Code: NQD · Immunology
• Decision Date: Dec 16, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Indications for Use

The CardioPhase® hsCRP assay is an in vitro diagnostic test for the quantitative determination of C-reactive protein (CRP) in human serum and plasma on Siemens Healthcare Diagnostics automated analyzers. Measurement of C-reactive protein is used for the detection and evaluation of infection, tissue injury, inflammatory disorders, and associated diseases. The CardioPhase® hsCRP assay is intended for use as an aid in the identification and management of inflammatory diseases and other conditions and as an aid in the assessment of risk of cardiovascular disease.

Device Story

CardioPhase® hsCRP is an in-vitro diagnostic reagent for quantitative CRP measurement via particle-enhanced immunonephelometry. Input: human serum, heparin plasma, or EDTA plasma. Principle: polystyrene particles coated with mouse monoclonal anti-CRP antibodies aggregate upon binding to CRP in the sample; aggregates scatter light; scattered light intensity is proportional to CRP concentration. Used on Siemens BN II and BN ProSpec® systems in clinical laboratories. Output: quantitative CRP concentration (mg/L). Healthcare providers use results as an independent risk marker for cardiovascular disease and prognosis for recurrent events in coronary syndromes. Benefits: aids in risk stratification and patient motivation for lifestyle improvements.

Clinical Evidence

Bench testing only. Verification and validation activities were performed based on risk analysis to confirm the impact of standardization to ERM-DA474 and the modified measuring range.

Technological Characteristics

In vitro diagnostic reagent; particle-enhanced immunonephelometry. Composition: polystyrene particles coated with mouse monoclonal antibodies. Energy source: light beam (nephelometry). Connectivity: used on BN II and BN ProSpec systems. Standardization: traceable to ERM-DA474/IFCC. Dimensions/form factor: liquid reagent suspension.

Indications for Use

Indicated for quantitative determination of CRP in human serum, heparin plasma, and EDTA plasma to detect/evaluate infection, tissue injury, and inflammatory disorders. Used as an independent risk marker for future cardiovascular disease and as a prognostic marker for recurrent events in patients with stable coronary disease or acute coronary syndromes. Contraindicated for patients with active infection, systemic inflammatory processes, or trauma until conditions abate.

Regulatory Classification

Identification

A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

Predicate Devices

• N High Sensitivity CRP (K033908)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K212559

B Applicant

Siemens Healthcare Diagnostics Products GmbH

C Proprietary and Established Names

CardioPhase® hsCRP

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NQD | Class II | 21 CFR 866.5270 - C-Reactive Protein Immunological Test System | IM - Immunology |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own Class II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of Siemens Healthcare Diagnostics Products GmbH's previously cleared device, N High Sensitivity CRP (K033908) which has been renamed to CardioPhase® hsCRP since it was cleared.
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. The changes were:

a. The Certified Reference Material ERM-DA470 was replaced with ERM-DA474 and the device was standardized to ERM-DA474.

b. The CRP1 workflow for the assay’s measuring range was changed from 3.1-200 mg/L to 3.1-100 mg/L.

4. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device.

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