RCRP Flex reagent cartridge

K221119 · Siemens Healthcare Diagnostics, Inc. · DCN · Mar 17, 2023 · Immunology

Device Facts

• Record ID: K221119
• Device Name: RCRP Flex reagent cartridge
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: DCN · Immunology
• Decision Date: Mar 17, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Indications for Use

The C-Reactive Protein Extended Range (RCRP) method used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of CRP in human serum and plasma (lithium heparin). Measurement of C-Reactive Protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.

Device Story

RCRP Flex reagent cartridge; in vitro diagnostic device for quantitative C-reactive protein (CRP) measurement in human serum/plasma. Used in clinical laboratory settings by trained personnel. Modification involves updated traceability of calibrators to ERM-DA474/IFCC standard reference material. Fundamental scientific technology remains unchanged from previously cleared device. Output used by clinicians to assess inflammation and disease states.

Clinical Evidence

No clinical data provided. Substantial equivalence established via design control activities, risk analysis, and verification/validation of modified calibrator traceability.

Technological Characteristics

Particle-enhanced turbidimetric immunoassay (PETIA). Reagents are prepackaged in cartridges for use on automated Dimension clinical chemistry systems. Standardization is traceable to ERM-DA474/IFCC reference material. Analytical measurement range: 5.0–250.0 mg/L. Complies with CLSI standards EP09c-ED3, EP17-A2, EP06-ED2, EP07-ED3, EP28-A3c, EP05-A3, and EP15-A3.

Indications for Use

Indicated for use as a C-Reactive Protein Immunological Test System for the quantitative determination of C-reactive protein in human serum and plasma.

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

• RCRP Flex reagent cartridge assay (K003419)

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

K221119

B Applicant

Siemens Healthcare Diagnostics Inc.

C Proprietary and Established Names

RCRP Flex reagent cartridge

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| DCN | 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. (For a preamendments device, a statement to this effect has been provided.)
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 demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for updated traceability of the calibrators to the most current standard reference material, ERMDA474/ IFCC.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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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 (or their preamendment) device.

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