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 Description

The RCRP method is based on a particle enhanced turbidimetric immunoassay (PETIA) technique. Synthetic particles coated with antibody to C-Reactive Protein (AbPR) aggregate in the presence of C-Reactive Protein in the sample. The increase in turbidity which accompanies aggregation is proportional to the C-Reactive Protein concentration.

AI/ML Overview

This document describes the RCRP Flex® reagent cartridge, an in vitro diagnostic test for the quantitative determination of C-Reactive Protein (CRP) in human serum and plasma. The submission is a special 510(k) for a modified device, primarily due to an update in traceability from IFCC CRM 470 to ERM-DA474/IFCC reference material and a change in the analytical measurement range (AMR).

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and observed performance are provided for the method comparison studies.

Attribute	Acceptance Criteria	Reported Device Performance (Modified RCRP vs. Predicate RCRP)	Pass/Fail	Reported Device Performance (RCRP Dimension RXL vs. N High Sensitivity CRP)	Pass/Fail
Slope	$1.00 \pm 0.1$	0.99	Pass	0.95	Pass
y-intercept	$0.0 \pm 2.0$ mg/L	-0.5 mg/L	Pass	-1.6 mg/L	Pass
Correlation Coefficient (r)	$\geq 0.9600$	1.000	Pass	0.997	Pass

Detection Capability (LoB, LoD, LoQ)

Specimen Type	Detection Capability	Acceptance Criteria	Result (mg/L / mg/dL)
Serum and Lithium Heparin Plasma	LoB	≤ LoD	0.6 mg/L (0.06 mg/dL)
	LoD	≤ LoQ	1.0 mg/L (0.10 mg/dL)
	LoQ	≤ 5.0 mg/L	5.0 mg/L (0.50 mg/dL)

Interference

Endogenous Substance Tested	Endogenous Substance Concentration	Analyte Concentration	Acceptance Criteria (Bias)	Bias (%)
Hemoglobin (hemolysate)	[500 mg/dL] 5.0 g/L	[11.6 mg/L] 1.16 mg/dL	Bias exceeding 10% is interference	0%
Bilirubin (Unconjugated)	[40 mg/dL] 684 µmol/L	[11.7 mg/L] 1.17 mg/dL	Bias exceeding 10% is interference	2%
Lipemia (Intralipid)	[250 mg/dL] 2.5 g/L	[11.8 mg/L] 1.18 mg/dL	Bias exceeding 10% is interference	-9%
Lipemia (Triglyceride Fraction)	[750 mg/dL] 7.5 g/L	[11.1 mg/L] 1.11 mg/dL	Bias exceeding 10% is interference	-7%

2. Sample Sample Size Used for the Test Set and Data Provenance

Method Comparison – Modified RCRP assay vs Predicate RCRP assay:
- Sample Size: 132 individual human native serum samples.
- Data Provenance: Samples were obtained from "specimen vendors". The country of origin is not specified, nor is whether the data is retrospective or prospective.
Method Comparison - RCRP assay on Dimension RXL system vs N High Sensitivity CRP on the BN™ System:
- Sample Size: 171 for the overall comparison (5.3 to 241.3 mg/L) and 39 for the narrower range (5.3 to 20.2 mg/L).
- Data Provenance: This study involved "re-analyzed historical IFU data." The original provenance (country, retrospective/prospective) of this historical data is not specified.
Linearity Testing: Not specified, but generally involves a set of diluted samples or spiked matrix covering the analytical measurement range.
Detection Capability (LoB, LoD, LoQ): Not specified.
Precision:
- Sample Size: 6 serum samples, analyzed with N=10 replicates each day for 5 days (total of 50 replicates per sample level).
Specimen Equivalency:
- Sample Size: 73 samples.
- Data Provenance: Not specified, but likely from specimen vendors similar to the method comparison.
Interference:
- Sample Size: Not explicitly stated, but typically involves a control sample and test samples (with interferent) for assessment of bias.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This document describes an in vitro diagnostic (IVD) test, specifically an immunoassay for C-Reactive Protein. The "ground truth" for such devices is typically established through a reference method or known concentrations of certified reference materials, not through expert consensus or interpretation in the same way an imaging AI might.

No human experts (e.g., radiologists) were used to establish ground truth for this type of device. The assessment is based on measured concentrations against established reference standards.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth for an IVD device like this is based on quantitative measurements and reference materials, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an in vitro diagnostic assay, not an AI-powered image analysis or diagnostic assist device that would involve human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This device is a standalone algorithm/reagent system designed for automated quantitative measurement on a clinical chemistry system. Its performance is evaluated intrinsically through various analytical studies (method comparison, linearity, precision, detection capability, interference) without human-in-the-loop performance influencing the measurement itself. The results are then interpreted by clinicians.

7. The Type of Ground Truth Used

The ground truth for this device is based on:

Reference Materials: For standardization, the device is traceable to ERM-DA474/IFCC reference material (and previously IFCC CRM 470). These are internationally recognized certified reference materials for CRP.
Comparative Methods: The performance is benchmarked against a predicate RCRP assay and the N High Sensitivity CRP on the BN™ System. These are established laboratory methods.
Clinical Laboratory Standards (CLSI): The studies follow guidelines from CLSI, which define how to robustly evaluate analytical performance parameters like precision, linearity, and detection limits.

8. The Sample Size for the Training Set

This document does not describe a machine learning or AI model that requires a distinct "training set" in the conventional sense. The device is a chemical reagent and assay system. Its "training" or development would involve extensive experimentation and optimization during the R&D phase to ensure reagent stability, reaction kinetics, and signal transduction are robust and accurate. This is not typically quantified as a "training set size" like in AI/ML contexts.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is not an AI/ML device with a defined training set and ground truth in that context. The "ground truth" for the development of such an assay would be through rigorous chemical and biological characterization, using known concentrations of analytes, reference materials, and established analytical chemistry principles.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

March 17, 2023

Siemens Healthcare Diagnostics Inc. Ian Thompson Regulatory Affairs Professional 511 Benedict Avenue Tarrytown, New York 10591

Re: K221119

Trade/Device Name: RCRP Flex reagent cartridge Regulation Number: 21 CFR 866.5270 Regulation Name: C-Reactive Protein Immunological Test System Regulatory Class: Class II Product Code: DCN Dated: January 20, 2023 Received: January 23, 2023

Dear Ian Thompson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ying Mao -S

Ying Mao, Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221119

Device Name RCRP Flex® reagent cartridge

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92 and the Safe Medical Device Act of 1990.

The assigned 510(k) Number is: K221119

1. Date Prepared

January 20, 2023

2. Applicant Information

Contact:	Ian ThompsonRegulatory Affairs Professional
Address:	511 Benedict AvenueTarrytown, NY 10591-5097

Email: ian_thompson@siemens-healthineers.com

3. Regulatory Information

Dimension RCRP Flex® reagent cartridge assay

Trade Name:	RCRP Flex® reagent cartridge
Common Name:	System, Test, C-Reactive Protein
Classification Name:	C-reactive protein immunological test system
FDA Classification:	Class II
Review Panel:	Immunology
Product Code:	DCN
Regulation Number:	21 CFR 866.5270

Predicate Device Information 4.

Predicate Device Name: RCRP Flex® reagent cartridge assay

510(k) Number: K003419

5. Intended Use / Indications For Use

Special Conditions for Use Statement(s): For Prescription Use Only.

6. Device Description

The RCRP method is based on a particle enhanced turbidimetric immunoassay (PETIA) technique.

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Synthetic particles coated with antibody to C-Reactive Protein (AbPR) aggregate in the presence of C-Reactive Protein in the sample. The increase in turbidity which accompanies aggregation is proportional to the C-Reactive Protein concentration.

Purpose of Submission 7.

The purpose of this submission is a special 510(k) premarket notification for a modified device: RCRP Flex® reagent cartridge assay. This device was modified by updating the traceability from the IFCC CRM 470 reference material to the ERM-DA474/IFCC reference material.

A Special 510(k) Premarket Notification is the requested pathway because of the following:

The change is to the manufacturer's own legally marketed device. .
There is no change to the intended use or indications for use. .
There is no change in the fundamental scientific technology.
There is no change to the principle of operation. ●
There is no change to the formulation.
. There is no change to the instrument parameters related to sample volume, reagent volume, mix speed, wavelengths, or read times.

8. Comparison of Candidate Device and Predicate Device

The table below describes the similarities and difference between the modified RCRP Flex reagent cartridge assay (Candidate Device) and RCRP Flex reagent cartridge assay (Predicate Device cleared under K003419). The Candidate Device and Predicate Device employ the same prepackaged reagents for use on an automated test system. The Intended Use / Indications for Use, assay principle, and reagent formulations are the same.

The Instructions for Use (IFU)/Package Insert for the Dimension Revised C-Reactive Protein Calibrator (RCRP CAL) was updated for this change.

Feature	Candidate Device	Predicate Device
	RCRP Flex reagent cartridge	RCRP Flex reagent cartridge
Intended Use	The C-Reactive Protein ExtendedRange (RCRP) method used on theDimension® clinical chemistry system isan in vitro diagnostic test intended forthe quantitative determination of CRPin human serum and plasma (lithiumheparin).	Same
Indications for Use	Measurement of C-Reactive Protein isuseful for the detection and evaluationof infection, tissue injury, inflammatorydisorders and associated diseases.	Same

The method comparison study between the Candidate Device and the Predicate Device demonstrated acceptable correlation.

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Feature	Candidate Device	Predicate Device
	RCRP Flex reagent cartridge	RCRP Flex reagent cartridge
Sample Type	serum and plasma (lithium heparin)	Same
Units of Measure	mg/L	Same
AnalyticalMeasurement Range	5.0 - 250.0 mg/L	0.5 - 250.0 mg/L
Expected Values	< 5.0 mg/L	3 mg/L
Assay Principle	Particle enhanced turbidimetricimmunoassay (PETIA)	Same
Standardization	ERM-DA474/IFCC	IFCC CRM 470
Calibrator Levels	Five levels	Same
Calibrator	Dimension Revised C-Reactive ProteinCalibrator	Same

Standard/Guidance Document References 9.

The following recognized standards from Clinical Laboratory Standards Institute (CLSI) were used as a basis of the study procedures described in this submission:

Evaluation Measurement Procedure Comparison and Bias Estimation Using Patient Samples (CLSI EP09c-ED3).

Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline-Second Edition (EP17-A2).

Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline (CLSI EP06-ED2).

Interference Testing in Clinical Chemistry: Approved Guidelines (CLSI EP07-ED3). Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory (CLSI EP28-A3c).

Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline-Third Edition (CLSI EP05-A3).

User Verification of Precision and Estimation of Bias; Approved Guideline-Third Edition (CLSI EP15-A3).

Summary of Design Control Activities 10.

A risk analysis was performed to evaluate the risks associated with the modification.

10.1 Risk Analysis

Risk analysis was conducted according to ISO 14971:2012 standard, Medical Devices -Application of Risk Management to Medical Devices, to assess the impact of the modification.

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510(k) Summary

This risk analysis supports that the modification did not introduce any new risk to the performance of the modified RCRP Flex reagent cartridge assay.

Verification Activities 10.2

Based on the risks analysis, verification testing was performed for updating the traceability from the IFCC CRM 470 reference material to the ERM-DA474/IFCC reference material. Method comparison, linearity, functional sensitivity/LoQ, and additional studies were conducted.

Method Comparison – Modified RCRP assay vs Predicate RCRP assay

Method comparison study was conducted in accordance with CLSI EP09-A3. Individual human native serum samples were tested on the Dimension RXL system. The serum samples were obtained from specimen vendors. The modified RCRP Flex reagent cartridge assay was calibrated with calibrator traceable to ERM-DA474/IFCC reference material. The predicate RCRP Flex reagent cartridge assay was calibrated with the calibrator traceable to IFCC CRM 470 reference material. A single replicate was processed for each sample on calibration conditions. Eighteen (18) out of 132 samples tested were within the range of 7.5 and 12.5 mg/L (14% of total samples). The slope, y-intercept, and correlation coefficient (r) results were generated using Deming regression. The correlation between the modified assay and the predicate assay are summarized below in Table 1 and Table 2.

Table 1. Method Comparison Results Summary
Modified Method (y)	Predicate Method (x)	Regression Equation	Sample Interval	Na	rb
RCRP with CalibratorTraceable to ERM-DA474/IFCC ReferenceMaterial	RCRP with CalibratorTraceable to IFCCCRM 470 ReferenceMaterial	$y = 0.99x - 0.5 mg/L$	5.0 to 247.6 mg/L	132	1.000

a Number of samples tested.

b Correlation coefficient.

Table 2. Method Comparison Requirements and Results Summary
Attribute	AcceptanceCriteria	Observed	Pass/Fail
Slope	$1.00 \pm 0.1$	0.99	Pass
y-intercept	$0.0 \pm 2.0$ mg/L	-0.5 mg/L	Pass
Correlation Coefficient (r)	$\geq 0.9600$	1.000	Pass

Method Comparison - RCRP assay on Dimension RXL system vs N High Sensitivity CRP on the BN™ System

For the change in the analytical measurement range (AMR) from [0.5 - 250.0 mg/L] 0.05 -25.00 mg/dL to [5.0 - 250.0 mg/L] 0.50 - 25.00 mg/dL, the historical IFU data was re-analyzed and the IFU was updated with the summary of the results for the method comparison of the candidate RCRP assay on Dimension RXL clinical chemistry system versus the predicate N High Sensitivity CRP on the BN™ System.

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The correlation between the candidate and the predicate are summarized below in Table 3 and Table 4.

Table 3. Method Comparison Re-Analyzed Results Summary
Candidate Method (y)	Predicate Method (x)	Regression Equation	Sample Interval	Na	rb
RCRP Dimension RXLclinical chemistry system	N High SensitivityCRP on the BNTM System	$y = 0.95x - 1.6$ mg/L	5.3 to 241.3 mg/L	171	0.997
		$y = 0.86x - 0.2$ mg/L	5.3 to 20.2 mg/L	39	0.986

Table 4. Method Comparison Requirements and Re-Analyzed Results Summary
Attribute	AcceptanceCriteria	Observed	Pass/Fail
Slope	$1.00 \pm 0.10$	0.95	Pass
y-intercept	$0.0 \pm 2.0$ mg/L	-1.6 mg/L	Pass
Correlation Coefficient (r)	$\geq 0.9600$	0.997	Pass

Linearity

Linearity study was conducted in accordance with CLSI EP06-ED2.

The modified RCRP Flex reagent cartridge assay is linear for the analytical measurement range of 5.0 - 250.0 mg/L.

Detection Capability

Verification of the existing Analytical Sensitivity and Functional Sensitivity in the Instructions for Use (IFU/Pacakage Insert) was replaced with conducting Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ) studies.

The Limit of Blank (LoB) corresponds to the highest measurement result that is likely to be observed for a blank sample. The assay is designed to have an LoB ≤ Limit of Detection (LoD).

The LoD corresponds to the lowest concentration of CRP that can be detected with a probability of 95%. The assay is designed to have an LoD ≤ the LoQ.

The LoQ corresponds to the lowest concentration of CRP in a sample at which the withinlaboratory precision is ≤ 20% CV. The assay is designed to have an LoQ ≤ [5.0 mg/L] 0.50 ma/dL.

Detection capability was determined in accordance with CLSI Document EP17-A2.

The results support the following claims:

Specimen Type	Detection Capability	Result
Serum andLithium Heparin Plasma	LoB	0.6 mg/L (0.06 mg/dL)
	LoD	1.0 mg/L (0.10 mg/dL)
	LoQ	5.0 mg/L (0.50 mg/dL)

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Precision

Precision was verified in accordance with CLSI Document EP05-A3. Samples at each level were analyzed N=10 replicates each day for 5 days. The following results were obtained:

SpecimenType	Na	Mean		Repeatability (Within-run)		CVc	Within-Lab (Total)		CV
		mg/L	mg/dL	mg/L	mg/dL	(%)	mg/L	mg/dL	(%)
Serum 1	50	6.8	0.68	0.08	0.008	1.2	0.12	0.012	1.8
Serum 2	50	9.1	0.91	0.07	0.007	0.8	0.17	0.017	1.9
Serum 3	50	37.7	3.77	0.32	0.032	0.8	0.42	0.042	1.1
Serum 4	50	108.4	10.84	1.07	0.107	1.0	1.59	0.159	1.5
Serum 5	50	208.3	20.83	3.37	0.337	1.6	4.76	0.476	2.3
Serum 6	50	233.4	23.34	3.95	0.395	1.7	6.15	0.615	2.6

a Number of replicates tested.

b Standard deviation.

C Coefficient of variation.

Specimen Equivalency

Specimen equivalency was verified using the Deming regression model in accordance with CLSI EP09C-ED3. The following results were obtained:

Specimen (y)	ReferenceSpecimen(x)	Regression Equation	Sample Interval	Na	rb
Lithium heparin plasma	Serum	y = 0.99x + 0.1 mg/L	5.2 to 243.2	73	1.00

a Number of samples tested.

b Correlation Coefficient.

Interference

For the change in the analytical measurement range (AMR) from [0.5 - 250.0 mg/L] 0.05 -25.00 mg/dL to [5.0 - 250.0 mg/L] 0.50 - 25.00 mg/dL, the hemolysis, icterus, and lipemia (HIL) interference study was repeated using sample with CRP analyte level within the new range.

The modified assay was evaluated for interference from hemolysis, icterus and lipemia according to EP07-ED3. Bias defined as the difference between the control sample (does not contain interferent) and the test sample (contains the interferent), is shown in the table below. Bias exceeding 10% is considered "interference".

EndogenousSubstance Tested	EndogenousSubstanceConcentration	Analyte Concentration	Bias(%)
Hemoglobin(hemolysate)	[500 mg/dL] 5.0 g/L	[11.6 mg/L] 1.16 mg/dL	0%

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EndogenousSubstance Tested	EndogenousSubstanceConcentration	Analyte Concentration	Bias(%)
Bilirubin(Unconjugated)	[40 mg/dL] 684 µmol/L	[11.7 mg/L] 1.17 mg/dL	2%
Lipemia (Intralipid)	[250 mg/dL] 2.5 g/L	[11.8 mg/L] 1.18 mg/dL	-9%
Lipemia(Triglyceride Fraction)	[750 mg/dL] 7.5 g/L	[11.1 mg/L] 1.11 mg/dL	-7%

Expected Values

The reference interval was verified in accordance with CLSI EP28-A3c.

The reference interval was verified as < 5.0 mg/L.

Comments on Substantial Equivalency 11.

The modified RCRP Flex reagent cartridge assay and the predicate RCRP Flex reagent cartridge assay are identical in composition, labeling and packaging. Verification testing results demonstrate equivalent performance.

12. Conclusion

Results from the risk analysis and design control activities with comparative testing support that the modified RCRP Flex reagent cartridge assay is substantially equivalent to the predicate RCRP Flex reagent cartridge assay (K003419).

Regulation Number and Section

§ 866.5270 C-reactive protein immunological test system.

(a)
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.(b)
Classification. Class II (performance standards).