Dimension Vista® IgA Flex® Reagent Cartridge: The IgA method is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin A in human serum and heparinized plasma by means of nephelometry on the Dimension Vista System. Measurements of IgA aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Dimension Vista® IGM Flex® reagent cartridge: The IgM method is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin M in human serum and heparinized plasma by means of nephelometry on the Dimension Vista" System. Measurements of IgM aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Device Description

Dimension Vista® IGA Flex® reagent cartridge: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the respective protein in the sample. The result is evaluated by comparison with a calibrator of known concentration.

Dimension Vista® IGM Flex® reagent cartridge: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes 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.

AI/ML Overview

The provided document describes the 510(k) summary for the Dimension Vista® IGA and IGM Flex® reagent cartridges. These devices are in vitro diagnostic tests for the quantitative measurement of Immunoglobulin A and Immunoglobulin M in human serum and heparinized plasma. The study presented here is a method comparison study to demonstrate substantial equivalence to previously marketed devices, rather than establishing direct acceptance criteria for a new clinical outcome.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The study aims to demonstrate substantial equivalence to predicate devices. The acceptance criteria for method comparison studies typically involve statistical measures such as slope, intercept, and correlation coefficient, demonstrating a strong agreement between the new device and the predicate. While explicit numerical acceptance criteria (e.g., "slope must be between X and Y") are not directly stated as "acceptance criteria" in this summary, the reported regression analysis results serve as the performance data to support equivalence.

Metric	Acceptance Criteria (Implied for Substantial Equivalence via Regression Analysis)	Dimension Vista® IGA Performance	Dimension Vista® IGM Performance
Slope (95% CI)	Close to 1.000 for strong agreement	1.000 (1.000, 1.000)	1.023 (0.967, 1.122)
Intercept (95% CI)	Close to 0.000 for strong agreement	0.000 (0.000, 0.000)	0.004 (-0.004, 0.008)
Correlation Coefficient (r)	Close to 1.000 for strong agreement	0.992	0.989
Correlation Coefficient (r²)	Close to 1.000 for strong agreement	0.983	0.979

Interpretation of Performance:

For the IgA assay, the slope of 1.000, intercept of 0.000, and very high correlation coefficients (r=0.992, r²=0.983) indicate excellent agreement with the predicate device (N Antiserum to Human IgA on the BN ProSpec® System) within the tested low-end range.
For the IgM assay, the slope of 1.023 (95% CI includes 1.000), intercept of 0.004 (95% CI includes 0.000), and high correlation coefficients (r=0.989, r²=0.979) also demonstrate strong agreement with the predicate device (N Antiserum to Human IgM on the BN ProSpec® System) within the tested low-end range.

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

Dimension Vista® IGA: 28 serum samples.
Dimension Vista® IGM: 26 serum samples.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "serum samples."

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

This study is a method comparison against a predicate device, not a diagnostic accuracy study where human experts establish ground truth. The "ground truth" in this context is the measurement obtained from the legally marketed predicate device (Siemens N Antisera to Human IgA and IgM on the BN ProSpec® System). Therefore, no human experts were used to establish ground truth for the test set in the traditional sense of clinical decision-making.

4. Adjudication Method for the Test Set

Not applicable. This was a method comparison study between a new device and a predicate device, not a study involving human readers or adjudicated outcomes.

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

No, an MRMC comparative effectiveness study was not done. This study is an in vitro diagnostic device comparison, not an evaluation of human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this study represents a "standalone" performance evaluation in that it assesses the analytical performance of the new device (Dimension Vista® IGA/IGM assays) independent of human interpretation or intervention beyond the standard laboratory procedures for running the tests. The performance is compared directly against another automated assay (the predicate device). However, it's important to differentiate this from "standalone AI algorithm performance" in the context of image analysis, for example. Here, "standalone" refers to the device's analytical performance on its own.

7. The Type of Ground Truth Used

The ground truth for this method comparison study was established by the measurements obtained from the legally marketed predicate devices:

Siemens N Antisera to Human IgA on the BN ProSpec® System.
Siemens N Antisera to Human IgM on the BN ProSpec® System.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or algorithm development. This is a traditional IVD device comparison study, not an AI/ML-driven device.

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

Not applicable, as there is no mention of a training set for an AI/ML algorithm in this context.

Summary

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510(k) Summary for Dimension Vista® IGA Assay Dimension Vista® IGM Assay

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.

090594

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

Manufacturer:	Siemens Healthcare Product GmbH
	Emil von Behring Str. 76
	Marburg, 35041 Germany

Contact Information: Siemens Healthcare Diagnostics P.O. Box 6101 Newark, Delaware 19714-6101 Attn: Kathleen Dray-Lyons Tel: 781-826-4551 Fax: 781-826-2497
Preparation date: April 9, 2009

The assigned 510(k) number is:

Dimension Vista® IGA Flex® reagent cartridge 2. Device Name: Dimension Vista® IGM Flex® reagent cartridge

Classification:	Class II; Class II
Product Code:	CFN
Panel:	Immunology (82)

3. Identification of the Legally Marketed Device:

Siemens N Antisera to Human IgA (K042735) Siemens N Antisera to Human IgM (K042735)

Device Description: 4.

Dimension Vista® IGA Flex® reagent cartridge

Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the respective protein in the sample. The result is evaluated by comparison with a calibrator of known concentration.

Dimension Vista® IGM Flex® reagent cartridge

Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample.

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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.

ﮩ ﭘ

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ട. Device Intended Use:

Dimension Vista® IgA Flex® Reagent Cartridge:

The IgA method is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin A in human serum and heparinized plasma by means of nephelometry on the Dimension Vista System. Measurements of IgA aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Dimension Vista® IGM Flex® reagent cartridge:

The IgM method is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin M in human serum and heparinized plasma by means of nephelometry on the Dimension Vista" System. Measurements of IgM aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

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

The Dimension Vista® IGA reagent cartridge and Dimension Vista "IGM reagent cartridge and are substantially equivalent to the Siemens N Antisera to Human IgA assay (K042735) and Siemens N Antisera to Human IgM (K042735) respectively. The Dimension Vistar IGA and IGM assays, like the N Antisera to Human IgA and IgM assays are an in vitro diagnostic reagents for the quantitative measurement of Immunoglobulin A and Immunoglobulin M in human serum and plasma.

7. Device Performance Characteristics:

In support of the extended range, the Dimension Vista® IgA assay was compared to N Antiserum to Human IqA on the BN ProSpec® System by evaluating 28 serum samples at the extended low end of the assay range with concentrations ranging from 0.062 to 0.246 g/L. Regression analysis of these results yielded the following equations:

	n	Slope(95%CI)	Intercept(95%CI)	CorrelationCoefficientr	CorrelationCoefficientr2
Dimension Vista®IgA	28	1.000(1.000, 1.000)	0.000(0.000, 0.000)	0.992	0.983

Method Comparison Study

In support extended range, the Dimension Vista® IgM assay was compared to N Antiserum to Human IgM on the BN ProSpec® System by evaluating 26 serum samples at the extended low end of the measuring range with concentrations ranging from 0.052 to 0.200 g/L. Regression analysis of these results yielded the following equations:

	n	Slope(95%CI)	Intercept(95%CI)	CorrelationCoefficientr	CorrelationCoefficientr2
Dimension Vista®IgM	26	1.023(0.967, 1.122)	0.004(-0.004, 0.008)	0.989	0.979

Method Comparison Study

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Siemens Healthcare Diagnostics c/o Ms Kathleen Ann Dray-Lyons Manager, Regulatory Affairs 500 GBC Drive P.O.Box 6101 Newark, DE 19714-6101

APR 2 9 2009

Re: K090594

Trade/Device Name: Dimension Vista® IGA Flex® reagent cartridge Dimension Vista® IGM Flex® reagent cartridge Regulation Number: 21 CFR §866.5510 Regulation Name: Immunoglobulins A, G, M, D and E Immunological Test System Regulatory Class: Class II Product Code: CFN Dated: March 03, 2009 Received: March 05, 2009

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); medical device reporting (reporting of

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Page 2 - Ms Kathleen Ann Dray-Lyons

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 vours.

ia m.chan

Maria M. Chan, 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 for Use

510(k) Number (if known):

Dimension Vista® IGM Flex® reagent cartridge Device Name:

Indications For Use:

Dimension Vista® IGM Flex® reagent cartridge:

The IgM method is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin M in human serum and heparinized plasma by means of nephelometry on the Dimension Vista® System. Measurements of IgM aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Prescription Use × (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter-Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation

Page 1 of

Manai M Chan

Division Sign-Off

Office of In Vitro Diagnostic ce Evaluation and Safety

510(k) K090594

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Indications for Use

510(k) Number (if known):

Dimension Vista® IGA Flex® reagent cartridge Device Name:

Indications For Use:

Dimension Vista® IgA Flex® Reagent Cartridge:

The IgA method is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin A in human serum and heparinized plasma by means of nephelometry on the Dimension Vista® System. Measurements of IgA aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Prescription Use X . (Per 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Maria M. Chan

Division Sign-Off

Office of In Vitro Dlagnostic Device Evaluation and Safety

s10(k) K090594

Regulation Number and Section

§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.

(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).