CRP Vario

K192118 · SENTINEL CH. SpA · DCK · Nov 8, 2019 · Immunology

Device Facts

• Record ID: K192118
• Device Name: CRP Vario
• Applicant: SENTINEL CH. SpA
• Product Code: DCK · Immunology
• Decision Date: Nov 8, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Indications for Use

The CRP Vario assay [CRPVa] is for in vitro diagnostic use in the quantitative immunoturbidimetric determination of C-reactive protein in human serum and plasma (sodium and lithium heparin) using the ARCHITECT c Systems. Measurement of C-reactive protein is useful in the detection and evaluation of infection, tissue injury and inflammatory disorders. CRP Calibrators (including CRP Calibrator Set, CRP Calibrator HS and CRP Calibrator WR) are intended to be used for the calibration of the CRP Vario for the quantitative determination of C-reactive protein in human serum or plasma samples.

Device Story

The CRP Vario is an in vitro diagnostic assay for quantitative C-reactive protein (CRP) measurement in human serum and plasma. It utilizes an immunoturbidimetric principle where rabbit anti-CRP polyclonal antibodies adsorbed on latex particles react with CRP in the sample, causing turbidity proportional to CRP concentration. The assay is performed on ARCHITECT c Systems. Healthcare providers use the resulting quantitative values to detect and evaluate infection, tissue injury, and inflammatory disorders. The device is used in clinical laboratory settings by trained laboratory personnel. The primary modification in this submission is the traceability of the assay from CRM 470 to ERM-DA472/IFCC, alongside the removal of EDTA as an acceptable anticoagulant and updated specimen storage stability (1 year at -20°C).

Clinical Evidence

Bench testing only; no clinical data provided. Verification and validation activities were performed based on risk analysis to confirm the impact of the traceability modification.

Technological Characteristics

Immunoturbidimetric assay. Reagents: Glycine buffer (pH 7.0) and rabbit anti-CRP polyclonal antibodies on latex particles. Standardized to ERM-DA472/IFCC. Compatible with ARCHITECT c Systems. Specimen types: Serum, lithium heparin plasma, sodium heparin plasma. Storage: 1 year at -20°C.

Indications for Use

Indicated for quantitative immunoturbidimetric determination of C-reactive protein in human serum and plasma (sodium and lithium heparin) to aid in detection and evaluation of infection, tissue injury, and inflammatory disorders.

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

• CRP Vario (K050836)

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

K192118

B Applicant

Sentinel CH, Spa

C Proprietary and Established Names

CRP Vario

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| DCK | 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 the SUBMITTER'S previously cleared device is CRP Vario (K050836).
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.
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.

This change was for the assay traceability from standard material CRM-470 to ERM-DA472/IFCC.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. 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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