Dimension Vista™ CRP Flex® reagent cartridge: The CRP method is an in vitro diagnostic test for the quantitative measurement of C-reactive protein (CRP) in human serum and heparinized plasma by means of particle enhanced immunonephelometry on the Dimension Vista™ System. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, are observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, and inflammatory disorders.

Dimension Vista™ Protein 2 Calibrator: Protein 2 Calibrator is an in vitro diagnostic product for the calibration of the C-reactive protein (CRP) method on the Dimension Vista ™ System.

Dimension Vista™ Protein 2 Control L and H: Protein 2 Control L and H are for use as assayed intralaboratory quality controls for the assessment of precision and analytical bias in determination of C-reactive protein (CRP) on the Dimension Vista™ System.

Device Description

Dimension Vista™ CRP Flex® reagent cartridge: Polystyrene particles coated with monoclonal antibodies specific to human CRP are aggregated when mixed with samples containing CRP. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

Dimension Vista™ Protein 2 Calibrator: Protein 2 Calibrator is a liquid human serum based product containing C-reactive protein (CRP).

Dimension Vista™ Protein 2 Control L and H: Protein 2 Control L and H are liquid human serum based products containing C-reactive protein (CRP).

AI/ML Overview

The provided text describes the 510(k) summary for the Dimension Vista™ CRP Flex® reagent cartridge, Dimension Vista™ Protein 2 Calibrator, and Dimension Vista™ Protein 2 Control L and H. It details the device's performance characteristics through a method comparison study.

Here's an analysis of the acceptance criteria and study as requested, based on the provided input:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for the method comparison study in a formalized table. However, the performance is reported through regression analysis, a common method to assess agreement between two assays. The key performance indicator provided is the correlation coefficient. While no specific threshold is given as an "acceptance criterion" within the text, correlation coefficients close to 1 are generally indicative of good agreement.

Performance Metric	Acceptance Criteria (Implied / Interpreted)	Reported Device Performance
Correlation Coefficient (r)	Close to 1.0 (indicating strong agreement)	0.997
Slope	Close to 1 (indicating proportional agreement)	0.985
Intercept	Close to 0 (indicating no systematic bias)	-0.353
Sample Range	Adequately covers the intended measurement range	3.36 to 182.76 mg/L

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

Sample Size: 140 serum and plasma samples were used in the method comparison study.
Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state if the study was retrospective or prospective. Given that samples with concentrations ranging from 3.36 to 182.76 mg/L were evaluated, it is likely that existing clinical samples were used, which would suggest a retrospective or observational nature of sample collection for this comparison study.

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

This information is not provided in the document. The "ground truth" in this context is the reference measurement from the predicate device (Dade Behring CardioPhase® hsCRP assay on the BN ProSpec® System). The document describes a comparison between two methods of analytical measurement. It does not involve expert interpretation of results to establish a "ground truth" for diagnostic purposes in the way a clinical study with radiologists or other specialists might.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human readers or experts interpret results and disagreements need to be resolved. This study is a direct analytical method comparison between two in vitro diagnostic assays.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a MRMC comparative effectiveness study was not done. This study focuses on the analytical performance comparison between a new in vitro diagnostic (IVD) assay and a predicate IVD assay, not on the impact of the assay on human reader performance or diagnostic effectiveness by human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, the study is essentially a standalone (algorithm only) performance assessment. The Dimension Vista™ CRP assay is an automated in vitro diagnostic test. The method comparison described assesses the device's ability to quantitatively measure CRP levels independently and compares these measurements to those obtained from a predicate device. There is no human interpretation "in the loop" for the measurement itself, only for the subsequent clinical use of the results.

7. The Type of Ground Truth Used:

The "ground truth" in this analytical comparison study is the measurements obtained from the legally marketed predicate device, the Dade Behring CardioPhase® hsCRP assay run on the BN ProSpec® System. This is considered the reference method for comparison.

8. The Sample Size for the Training Set:

The document does not provide information about a separate "training set" for the Dimension Vista™ CRP assay. IVD devices like this are typically developed and validated using a variety of studies (e.g., linearity, precision, interference, method comparison). While development data would have been used during the assay's creation, the provided text describes a specific "method comparison study" which serves as part of the validation/test phase for regulatory submission.

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

As no specific "training set" is described for this regulatory submission (which focuses on validation), information on how its ground truth was established is not provided. If an internal training set was used during product development, its ground truth would likely have been established using reference methods similar to how the predicate device served as the "ground truth" for this method comparison.

Summary

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SEP - 6 2006

510(k) Summary for Dimension Vista™ CRP Flex® reagent cartridge Dimension Vista™ Protein 2 Calibrator Dimension Vista™ Protein 2 Control L and H

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.

The assigned 510(k) number is: KO60825

1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:
  Manufacturer:

Dade Behring Marburg GmbH Emil-von-Behring Str. 76 D-35001 Marburg, Germany

Contact Information: Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714-6101 Attn: Kathleen Dray-Lyons Tel: 781-826-4551

Preparation date: August 24, 2006

1. Dimension Vista™ C-reactive protein Flex® reagent cartridge (CRP) Device Name: Dimension Vista™ Protein 2 Calibrator Dimension Vista™ Protein 2 Control L Dimension Vista™ Protein 2 Control H
  Classification: Class II; Class II: Class I Product Code: DCK; JIX, JJY Panel: Immunology (82) and Clinical Chemistry (75)

Fax: 781-826-2497

ldentification of the Legally Marketed Device: 3.

Dade Behring CardioPhase® hsCRP - K033908 Dade Behring N Rheumatology Standard SL - K964527 Dade Behring N/T Rheumatology Control SL - K962373

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4. Device Description:

Dimension Vista™ CRP Flex® reagent cartridge

Polystyrene particles coated with monoclonal antibodies specific to human CRP are aggregated when mixed with samples containing CRP. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

Dimension Vista™ Protein 2 Calibrator

Protein 2 Calibrator is a liquid human serum based product containing C-reactive protein (CRP).

Dimension Vista™ Protein 2 Control L and H

Protein 2 Control L and H are liquid human serum based products containing C-reactive protein (CRP).

5. Device Intended Use:

Dimension Vista™ CRP Flex® reagent cartridge:

The CRP method is an in vitro diagnostic test for the quantitative measurement of Creactive protein (CRP) in human serum and heparinized plasma by means of particle enhanced immunonephelometry on the Dimension Vista™ System. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, are observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, and inflammatory disorders.

Dimension Vista™ Protein 2 Calibrator:

Protein 2 Calibrator is an in vitro diagnostic product for the calibration of the C-reactive protein (CRP) method on the Dimension Vista ™ System.

Dimension Vista™ Protein 2 Control L and H:

Protein 2 Control L and H are for use as assayed intralaboratory quality controls for the assessment of precision and analytical bias in determination of C-reactive protein (CRP) on the Dimension Vista™ System.

6. Medical device to which equivalence is claimed and comparison information:

The Dimension Vista™ CRP Flex reagent cartridge, Dimension Vista™ Protein 2 Calibrator and Dimension Vista™ Protein 2 Control L and H are substantially equivalent to the Dade Behring CardioPhase® hsCRP assay (K033908) assay, N Rheumatology Standard SL (K964527) and N/T Rheumatology Control SL (K962373), respectively. The Dirension
Vista™ CRP assay, like the Dade Behring CardiPhase® hsCRP assay is an in vitro diagnostic reagent for the quantitative measurement of C-reactive protein (CRP) in human serum and plasma by means of particle enhanced immunonephelometry.

7. Device Performance Characteristics:

The Dimension Vista™ CRP assay was compared to the Dade Behring CardioPhase®
hsCRP assay on the BN ProSpec® System by evaluating serum and plasma samples with concentrations ranging from 3.36 to 182.76 mg/L. Regression analysis of these results yielded the following equation:

Method Comparison Study

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Dimension Vista™ CRP	140	0.985	-0.353	Coefficient0.997
----------------------	-----	-------	--------	----------------------

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circle around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kathleen Dray-Lyons Regulatory Affairs and Compliance Manager Dade Behring, Inc. P.O. Box 6101 Newark, DE 19714

SEP - 6 2006

Re: K061825

Trade/Device Name: Dimension Vista™ CRP Flex® reagent cartridge Dimension Vista™ Protein 2 Calibrator Dimension Vista™ Control L Dimension Vista™ Control H

Regulation Number: 21 CFR 866.5270

Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCN, JIX, JJY Dated: June 27, 2006 Received: June 28, 2006

Dear Ms. Dray-Lyons:

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. 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Guts

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

Dimension Vista™ CRP Flex® reagent cartridge Device Name: Dimension Vista™ Protein 2 Calibrator Dimension Vista™ Protein 2 Control L Dimension Vista™ Protein 2 Control H

Indications for Use:

Dimension Vista™ CRP Flex® reagent cartridge:

The CRP method is an in vitro diagnostic test for the quantitative measurement of C-reactive protein (CRP) in human serum and heparinized plasma by means of particle enhanced immunonephelometry on the Dimension Vista™ System. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, are observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, and inflammatory disorders.

Dimension Vista™ Protein 2 Calibrator:

Protein 2 Calibrator is an in vitro diagnostic product for the calibration of the C-reactive protein (CRP) method on the Dimension Vista 10 System.

Dimension Vista™ Protein 2 Control L and Dimension Vista™ Protein 2 Control H:

Prescription Use × (Per 21 CFR 801 Subpart D) Over-The-Counter-Use (21 CFR 801)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benson

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Avision Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K06/825

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).