The Revised C-Reactive Protein (RCRP) Flex™ reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to quantitatively measure Creactive protein in human serum and plasma. Measurements of C-reactive protein are used in the evaluation of the amount of injury to body tissues.

Device Description

The RCRP method is based on a particle enhanced turbidmetric immunoassay (PETIA) technique. Latex particles coated with antibody to C-Reactive Protein 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. The concentration is determined by means of a mathematical function.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Implicit)	Reported Device Performance
Quantitative equivalence to predicate device (N Latex CRP mono assay):	Correlation coefficient: 0.998
- High correlation coefficient (R-value close to 1)	Slope: 0.95
- Slope close to 1	Intercept: -0.13 mg/L [-1.3 mg/L]
Qualitative equivalence to predicate device (N Latex CRP mono assay):
- Ability to measure C-Reactive Protein in human serum and plasma.	Same sample types (serum and plasma) as the predicate device.
- Intended Use aligned with the predicate device (implied, as substantial equivalence is claimed based on this comparison study).	Intended Use: "quantitatively measure C-Reactive Protein in human serum and plasma." This aligns with the C-Reactive Protein Test System classification, implying similar intended use to the predicate.
- Robustness of measurement through a recognized immunoassay technique.	Utilizes a "particle enhanced turbidimetric immunoassay (PETIA) technique," which is a recognized method for such measurements, though different from the predicate's "particle agglutination immunonephelometry." The performance demonstrates this technique is equivalent for the stated purpose.
Safety and Effectiveness: (General regulatory requirement, not specific numerical criteria given for this device in the document snippet)	The FDA's 510(k) clearance explicitly states: "We have determined the device is substantially equivalent... You may, therefore, market the device, subject to the general controls provisions of the Act." This implies the device meets the general requirements for safety and effectiveness for its intended use through substantial equivalence.

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

Sample Size: 221 clinical patient samples.
Data Provenance: Retrospective, as indicated by "clinical patient samples." The country of origin is not specified in the provided text.

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

The document does not provide information regarding experts establishing ground truth for the test set. The study compares the performance of the new device against a legally marketed predicate device (N Latex CRP mono assay), assuming the predicate device's measurements constitute the "ground truth" or reference for establishing equivalence.

4. Adjudication Method for the Test Set

No adjudication method is described. The study is a direct comparison between two measurement devices rather than an interpretation of results by multiple human readers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size

No MRMC comparative effectiveness study was done. This study focuses on device performance equivalence, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was done. The RCRP Flex™ reagent cartridge is a fully automated in-vitro diagnostic device. The performance data (correlation, slope, intercept) demonstrate its standalone analytical performance compared to the predicate device, without human intervention in the measurement process itself.

7. Type of Ground Truth Used

The "ground truth" for this study was established using the measurements from the predicate device, the N Latex CRP mono assay (K962523). The study aims to show that the new device's measurements are substantially equivalent to those of a previously cleared device.

8. Sample Size for the Training Set

The document does not specify a training set sample size. This type of immunoassay device (particle enhanced turbidimetric immunoassay) typically relies on chemical and biological principles for its operation and calibration curves, rather than machine learning models that require distinct training sets. Calibration would be performed during manufacturing and potentially by users, but the "training set" concept as used in AI/ML is not applicable here.

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

Not applicable, as there's no mention of a traditional "training set" in the context of an AI/ML algorithm. The calibration of the device (if applicable) would typically be established using reference materials with known concentrations of C-Reactive Protein, but this is not detailed in the provided summary.

Summary

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K990825-

4/10/99

DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714

DADE BEHRING

Summary of Safety and Effectiveness Information

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Submitter's Name:	Lorraine Piestrak
	Dade Behring Inc.
	P.O. Box 6101
	Newark, DE 19714-6101
Date of Preparation:	March 11, 1999
Name of Product:	Revised C-Reactive Protein (RCRP) Flex™ reagent cartridge
FDA Classification Name:	C-Reactive Protein Test System
Predicate Device:	N Latex CRP mono assay (K962523)

Device Description: The RCRP method is based on a particle enhanced turbidmetric immunoassay (PETIA) technique. Latex particles coated with antibody to C-Reactive Protein 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. The concentration is determined by means of a mathematical function.

Intended Use: The RCRP Flex™ reagent cartridge is used in the Dimension® clinical chemistry system to quantitatively measure C-Reactive Protein in human serum and plasma.

Comparison to Predicate Device:

Item	RCRP Flex™ reagent cartridge	N Latex CRP mono
Sample Type	serum and plasma	serum and plasma
Technology	particle enhancedturbidimetric immunoassay(PETIA)	particle agglutinationimmunonephelometry
Antibody	goat polyclonal	mouse monoclonal
Detection	Aggregation (turbidimetric)measurement	Agglutinationmeasurement

Comments on Substantial Equivalence:

Split sample comparison between the RCRP Flex™ reagent cartridge on the Dimension® clinical chemistry system and the N Latex CRP mono assay gave a correlation coefficient of 0.998, slope of 0.95, and an intercept of -0.13 mg/L [-1.3mg/L] when tested with 221 clinical patient samples.

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DADE BEHRING

Conclusion: The RCRP Flex™ reagent cartridge is substantially equivalent in principle and performance to the N Latex CRP mono assay based on the split sample comparison discussed above.

Lorraine Pastrack

Lorraine Piestrak Quality Assurance and Compliance Manager March 11, 1999

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three curved lines representing its wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

APR 1 6 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lorraine Piestrak Quality Assurance and Compliance Manager Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714-6101

K990825 Re:

Trade Name: Revised C-Reactive Protein (RCRP) Flex™ Reagent Cartridge Regulatory Class: II Product Code: DCN Dated: March 11, 1999 Received: March 12, 1999

Dear Ms. Piestrak:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use Statement

Device Name: Revised C-Reactive Protein (RCRP) Flex™ reagent cartridge

Indications for Use:

Lorraine Pastore

Lorraine Piestrak Quality Assurance and Compliance Manager

March 11, 1999

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

(División Sign-Off)
Division of Clinical Laboratory Devices 119988825
510(k) Number

Prescription Use سل (Per 21 CFR 801.109)

Over-the-counter Use

(Optional format 1-2-96)

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).