Dimension Vista™ RF Flex® reagent cartridge: The RF method is an in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human serum and lithium heparin plasma on the Dimension Vista™ System. Measurements of RF are used as an aid in the diagnosis of rheumatoid arthritis.

Dimension Vista™ Protein 2 Calibrator: PROT2 CAL is an in vitro diagnostic product for the calibration of the C-reactive protein (CRP), high sensitivity CRP (hsCRP) and Rheumatoid Factors (RF) methods on the Dimension Vista™ System.

Dimension Vista™ Protein 2 Controls L and H: PROT2 CON L and H are assayed intralaboratory quality controls for the assessment of precision and analytical bias in the determination of C-reactive protein (CRP) and Rheumatoid Factors (RF) on the Dimension Vista™ System.

Device Description

Dimension Vista™ RF Flex® reagent cartridge: Polystyrene particles coated with an immunocomplex consisting of human immunoglobulin and anti-human IgG from sheep are aggregated when mixed with samples containing RF. 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: PROT2 CAL is a liquid, human serum based product containing C-reactive protein and Rheumatoid Factors.

Dimension Vista™ Protein 2 Control L and H: PROT2 CON L and H are liquid, multi-analyte, human serum based products containing C-reactive protein and Rheumatoid Factors.

AI/ML Overview

Here's an analysis of the provided text regarding the Dimension Vista™ RF Flex® reagent cartridge and its associated calibrator and controls:

Acceptance Criteria and Device Performance

The acceptance criteria for the Dimension Vista™ RF assay are implied by its comparison to a legally marketed predicate device (ROCHE Tina-Quant RF II assay). The study aims to demonstrate substantial equivalence, meaning the new device performs similarly to the established one.

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Dimension Vista™ RF)
Method Comparison (Correlation)	Implied to be strong agreement with the predicate device (ROCHE Tina-Quant RF II assay). While specific R-squared thresholds are not explicitly stated, regulatory bodies typically look for an R-squared value close to 1 (e.g., >0.95 or 0.97) for quantitative assays to demonstrate substantial equivalence, along with acceptable slope and intercept values close to 1 and 0 respectively for proportional and constant bias.	The document states: "Regression analysis of these results yielded the following equation: Antercept of the Slope Slope Intercept ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------and the maintent of the many of the country and the been andand the support of the first to the status and the many ofand the first and the country of the first and the basicing the coun-political Mac and Children and other contract and announce and more. "This to Molly 40.000 100 11:10 Personal Provider and proving are and andand the province and securities and the property of the province andwith a wounder commended to the country of the managea strength of the station would be any cases and cases of the promote Company of the country of the program and the program and the program and.
Intended Use Equivalence	Quantitative determination of rheumatoid factors (RF) in human serum and lithium heparin plasma as an aid in the diagnosis of rheumatoid arthritis.	The Dimension Vista™ RF Flex® reagent cartridge has the same intended use: "in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human serum and lithium heparin plasma on the Dimension Vista™ System. Measurements of RF are used as an aid in the diagnosis of rheumatoid arthritis."

Study Details:

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: The document states that the Dimension Vista™ RF assay was compared to the ROCHE Tina-Quant RF II assay "by evaluating serum samples with concentrations ranging from 10 to 520 IU/ML." The exact number of samples (N) is not explicitly stated in the provided text.
Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective in nature, as it involves comparing the new device against existing serum samples previously analyzed by the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This type of in vitro diagnostic device (IVDD) study (quantitative measurement of a biomarker) typically does not rely on human experts to establish "ground truth" for individual sample values. Instead, the "ground truth" for the test samples is established by the predicate device's measurement. The study measures the agreement between the new device and the predicate.
Therefore, no experts were used to establish ground truth in the traditional sense (e.g., radiologists interpreting images). The "ground truth" is analytical, derived from the established method.

4. Adjudication method for the test set:

None. Adjudication is typically used in clinical studies where expert disagreement on a diagnosis or finding needs to be resolved. For a quantitative IVDD comparison, the predicate device's result is taken as the reference.

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:

No. This is not an MRMC study. MRMC studies are relevant for imaging diagnostics or other subjective interpretations where human readers are involved. This is a study comparing the analytical performance of two automated diagnostic assays.

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

Yes, this is essentially a standalone performance study. The Dimension Vista™ RF assay is an automated diagnostic assay. Its performance is evaluated directly through its measurements on patient samples, without human intervention in the result generation or interpretation for the purpose of this comparison study. The comparison is between two automated systems.

7. The type of ground truth used:

The ground truth for the samples used in the method comparison study was established by the predicate device, the ROCHE Tina-Quant RF II assay. This means the values obtained from the predicate device were considered the reference against which the Dimension Vista™ RF assay's results were compared.

8. The sample size for the training set:

The document does not provide information on a specific "training set" sample size. As an analytical assay, the development may involve internal optimization and calibration processes, but a distinct "training set" in the context of machine learning or AI development is not detailed here. The focus for regulatory submission is on the validation against the predicate and performance characteristics.

9. How the ground truth for the training set was established:

Since a "training set" is not explicitly mentioned or detailed in the provided text in the context of device development or performance, this information is not available. For analytical assays, internal development processes would typically involve using known concentration standards and reference materials to calibrate and optimize the assay's performance.

Summary

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OCT - 4 2006

510(k) Summary for Dimension Vista™ RF Flex® reagent cartridge Dimension Vista™ Protein 2 Calibrator Dimension Vista™ Protein 2 Control L Dimension Vista™ Protein 2 Control 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: Ko 62035

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 Dade Behring Inc. Contact Information: P.O. Box 6101 Newark, Delaware 19714-6101 Attn: Kathleen Dray-Lyons Tel: 781-826-4551 Fax: 781-826-2497 Preparation date: September 11, 2006 2. Device Name: Dimension Vista™ Rheumatoid Factors Flex® reagent cartridge (RF) 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: DHR: JIX: JJY Panel: Immunology (82) and Clinical Chemistry (75)

3. ldentification of the Legally Marketed Device:

ROCHE Tina-Quant RF II assay - K032535 N Rheumatology Standard SL - K964527 N/T Rheumatology Control SL - K962373

4. Device Description:

Dimension Vista™ RF Flex® reagent cartridge

Polystyrene particles coated with an immunocomplex consisting of human immunoglobulin and anti-human IgG from sheep are aggregated when mixed with samples containing RF. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the

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respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

Dimension Vista™ Protein 2 Calibrator

PROT2 CAL is a liquid, human serum based product containing C-reactive protein and Rheumatoid Factors.

Dimension Vista™ Protein 2 Control L and H

PROT2 CON L and H are liquid, multi-analyte, human serum based products containing C-reactive protein and Rheumatoid Factors.

5. Device Intended Use:

Dimension Vista™ RF Flex® reagent cartridge:

The RF method is an in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human serum and lithium heparin plasma on the Dimension Vista™ System. Measurements of RF are used as an aid in the diagnosis of rheumatoid arthritis.

Dimension Vista™ Protein 2 Calibrator:

PROT2 CAL is an in vitro diagnostic product for the calibration of the C-reactive protein (CRP), high sensitivity CRP (hsCRP) and Rheumatoid Factors (RF) methods on the Dimension Vista™ System.

Dimension Vista™ Protein 2 Controls L and H:

PROT2 CON L and H are assayed intralaboratory quality controls for the assessment of precision and analytical bias in the determination of C-reactive protein (CRP) and Rheumatoid Factors (RF) on the Dimension Vista™ System.

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

The Dimension Vista™ RF Flex® reagent cartridge, Dimension Vista™ Protein 2 Calibrator and Dimension Vista™ Protein 2 Controls L and H are substantially equivalent to the ROCHE Tina-Quant RF II assay (K032535), N Rheumatology Standard SL (K964527) and N/T Rheumatology Control SL (K962373), respectively. The Dimension Vista™ RF assay, like the ROCHE Tina-Quant RF II assay is an in vitro diagnostic test for the quantitative determination of Rheumatoid Factors in human serum and heparinized plasma.

Device Performance Characteristics: 7.

The Dimension Vista™ RF assay was compared to the ROCHE Tina-Quant RF II on the Hitachi 917 Analyzer by evaluating serum samples with concentrations ranging from 10 to 520 IU/ML. Regression analysis of these results yielded the following equation:

Antercept of the Slope Slope Intercept ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------and the maintent of the many of the country and the been andand the support of the first to the status and the many ofand the first and the country of the first and the basicing the coun-political Mac and Children and other contract and announce and more. "This to Molly 40.000 100 11:10 Personal Provider and proving are and andand the province and securities and the property of the province andwith a wounder commended to the country of the managea strength of the station would be any cases and cases of the promote	Company of the country of the program and the program and the program and.	.Ben and the first the career and state and the count	Market Medical Comments of Children Comments of Children Company of Childrenand and the production of the country of the country of the continued andand the state and a program and consideredthe summer of the first to the state and the successful and the may be any andthe Research and the contraction of the status and the many ofA	Company of the country of the country of the county of the county of the county ofControllers of the control control control control and the status and theCorrelatioThe first of the first of the first of the first of the first of the first of the first of the first of the first of the first andCARRE DE RECENT OF CARAL CONSULT OF CONSULTION OFA SPECIELLEсенерге советские повенности податистери

Method Comparison Study

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a wavy line.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT - 4 2006

Dade Behring. Inc. c/o Ms. Kathleen Dray-Lyons Regulatory Affairs and Compliance Manager Glasgow Site P.O. Box 6101 Newark. DE 19714

Re: K062035

Trade/Device Name: Dimension Vista™ Rheumatoid Factors Flex® reagent cartridge Dimension Vista™ Protein 2 Calibrator Dimension Vista™ Protein 2 Control L., Dimension Vista™ Protein 2 Control H Regulation Number: 21 CFR 866.5775 Regulation Name: Rheumatoid Factor Immunological Test System Regulatorv Class: Class II Product Code: DHR, JIX, JJY Dated: July 13, 2006 Received: July 19, 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 Mav 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 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 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); good manufacturing practice requirements as set forth in the quality

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systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Robert Becker

Robert L. Becker, Jr., M.D., Ph,D Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications Statement

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

Indications for Use:

Dimension Vista™ RF Flex® reagent cartridge:

The RF method is an in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human serum and lithium heparin plasma on the Dimension Vista ™ System. Measurements of RF are used as an aid in the Dinemistori
adhritis arthritis.

Dimension Vista™ Protein 2 Calibrator:

PROT2 CAL is an in vitro diagnostic product for the calibration of the C-reactive protein (CRP), high sensitivity CRP (hsCRP) and Rheumatord Factors (RF) methods on the Dimension Vista™ System.

Dimension Vista™ Protein 2 Controls L and H:

Prescription Use X (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)

Marisa Chan
Division Sign-Off

Page 1 of

Office of In Vitro Digana Device Evaluation and Safety

510(k) K062035

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.