The IGG1 method is an in vitro diagnostic test for the quantitative measurement of immunodobulin G subclass 1 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista® System. Measurements of immunoglobulin G subclass 1 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findings.

The IGG2 method is an in vitro diagnostic test for the quantitative measurement of immunodobulin G subclass 2 in human serum. heparinized plasma and EDTA plasma on the Dimension Vista" System. Measurements of immunoglobulin G subclass 2 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findings.

The IGG3 method is an in vitro diagnostic test for the quantitative measurement of immunodobulin G subclass 3 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System. Measurements of immunoglobulin G subclass 3 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findings.

The IGG4 method is an in vitro diagnostic test for the quantitative measurement of immunodobulin G subclass 4 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista" System. Measurements of immunoglobulin G subclass 4 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findinas.

Device Description

Dimension Vista® IGG 1-2 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 standard of known concentration.

Dimension Vista® IGG 3-4 Flex® reagent cartridge: Antibodies as well as polystyrene particles coated with antibodies specific to human IGG3 or IGG4 are aggregated when mixed with samples containing IGG3 or IGG4. 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dimension Vista® IGG Subclass assays:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as 'acceptance criteria' in the document. Instead, the study aims to demonstrate substantial equivalence to legally marketed predicate devices through method comparison. The performance is reported as the results of the regression analysis comparing the new device to the predicate device.

Test	Performance Metric	Acceptance Criteria (Implied for Substantial Equivalence via Method Comparison)	Reported Device Performance
Dimension Vista® IGG1	Slope	Close to 1.00	1.002
	Intercept (g/L)	Close to 0	-0.165
	Correlation Coefficient	Close to 1.00	0.994
Dimension Vista® IGG2	Not explicitly detailed in provided text, but implied to be similar to IGG1 against its specific predicate.		1.002 (from the "Method Comparison Study" table, though it's confusingly placed and listed with IGG1's n of 129, indicating it might be a general header for the IGG assays rather than specific data for IGG2 at that point.) Self-correction: The "Method Comparison Study" table has 'Dimension Vista® IGG1' and 'Dimension Vista® IGG2' but the 'n' for IGG2 is missing, and 'Slope', 'Intercept', and 'Correlation Coefficient' data are also not present for IGG2 in that specific table segment for the Siemens N Antisera comparison. The document states "The Dimension Vista® IGG 1 and 2 assays were compared to N Antiserum to Human IgG Subclasses 1 and 2 on the BN ProSpec® System." The table provided only shows data for IGG1 for this comparison. Therefore, I cannot extract IGG2 performance from the provided text for this comparison.
Dimension Vista® IGG3	Slope	Close to 1.00	1.047
	Intercept (g/L)	Close to 0	-0.002
	Correlation Coefficient	Close to 1.00	0.993
Dimension Vista® IGG4	Slope	Close to 1.00	1.020
	Intercept (g/L)	Close to 0	-0.009
	Correlation Coefficient	Close to 1.00	0.996

Note on IGG2 data: The provided text has a gap in reporting the specific method comparison results (Slope, Intercept, Correlation Coefficient) for Dimension Vista® IGG2. While it states it was compared, the table only shows IGG1's results against the N Antiserum.

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

Dimension Vista® IGG1: The test set used a sample size (n) of 129 (human serum/plasma samples, as described in the device's intended use).
Dimension Vista® IGG3: The test set used a sample size (n) of 142 (human serum/plasma samples).
Dimension Vista® IGG4: The test set used a sample size (n) of 150 (human serum/plasma samples).
Data Provenance: The document does not specify the country of origin of the data. It does not explicitly state if the data was retrospective or prospective, although method comparison studies usually involve prospectively collected samples or a mixed approach of existing and newly collected samples for spanning the measuring range.

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

This type of information is generally not applicable to in vitro diagnostic (IVD) devices like the one described. The "ground truth" in this context is the measurement obtained from the legally marketed predicate device (Siemens N Antisera to Human IgG Subclasses 1 and 2, and Siemens N Latex IgG3 and 4 assays run on the BN ProSpec® System). These are established diagnostic assays, and their results are treated as the reference for comparison, not requiring expert consensus for individual sample values.

4. Adjudication Method for the Test Set

Not applicable. For IVD devices comparing to a predicate, the predicate device's result is the reference point, not an adjudicated "ground truth" derived from human experts.

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 imaging device or AI-assisted diagnostic tool that involves human readers/interpreters in the decision-making process. The device performs quantitative measurements directly.

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

Yes, a standalone performance study was done. The method comparison described (new device vs. predicate device) assesses the performance of the Dimension Vista® IGG Subclass assays as standalone devices. The results are quantitative measurements, not dependent on human interpretation of the assay's output for diagnosis, though clinicians interpret the quantitative results in conjunction with other findings.

7. The Type of Ground Truth Used

The "ground truth" for the method comparison studies was the results obtained from the legally marketed predicate devices:

Siemens N Antisera to Human IgG Subclasses 1 and 2 (for IGG1 and IGG2)
Siemens N Latex IgG3 and 4 (for IGG3 and IGG4)

These predicate devices were run on the BN ProSpec® System.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" or its sample size. For an IVD device submission, the focus is typically on verification and validation studies (like method comparison) using clinical samples, rather than a separate "training set" in the context of machine learning algorithms. The development and internal optimization of the assay might involve various samples, but these are generally considered part of the development phase leading up to the formal validation studies.

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

As no training set is explicitly mentioned or detailed in the document in the context of algorithm development, this question is not applicable. The performance characteristics are evaluated against established predicate methods.

Summary

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OCT 21 2009

510(k) Summary for Dimension Vista® IGG Subclass 1 Assav Dimension Vista® IGG Subclass 2 Assay Dimension Vista® IGG Subclass 3 Assay Dimension Vista® IGG Subclass 4 Assav

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: _______________________________________________________________________________________________________________________________________________

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

Manufacturer:	Siemens Healthcare Product GmbHEmil von Behring Str. 76Marburg, 35041 Germany
---------------	---------------------------------------------------------------------------------------

Siemens Healthcare Diagnostics 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 9, 2009

Dimension Vista® IGG1 Flex® reagent cartridge 2. Device Name: Dimension Vista® IGG2 Flex® reagent cartridge Dimension Vista® IGG3 Flex® reagent cartridge Dimension Vista® IGG4 Flex® reagent cartridge
IGG (Gamma Chain Specific),Class II Classification: Product Code: DFZ Immunology (82) Panel:

Identification of the Legally Marketed Device: 3.

Siemens N Antisera to Human IgG subclasses 1 and 2 Siemens N Latex IqG Subclasses 3 and 4

4. Device Description:

Dimension Vista® IGG 1-2 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 standard of known concentration.

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Dimension Vista® IGG 3-4 Flex® reagent cartridge

Antibodies as well as polystyrene particles coated with antibodies specific to human IGG3 or IGG4 are aggregated when mixed with samples containing IGG3 or IGG4. 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.

5. Device Intended Use:

Dimension Vista® IGG1 Flex® Reagent Cartridge:

The IGG1 method is an in vitro diagnostic test for the quantitative measurement of immunodobulin G subclass 1 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System. Measurements of immunoglobulin G subclass 1 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findings.

Dimension Vista® IGG2 Flex® reagent cartridge:

Dimension Vista® IGG3 Flex® reagent cartridge:

Dimension Vista® IGG4 Flex® reagent cartridge:

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

The Dimension Vista® (GG1, 2, 3 and 4 reagent cartridges are substantially equivalent to the Siemens N Antisera to Human IqG Subclasses 1 and 2 assay and Siemens N Latex IgG3 and 4 respectively. The Dimension Vista® IGG1, 2, 3 and 4 assays, like the N Antisera to Human IgG Subclasses 1 and 2 and N Latex IGG 3 and 4 assays are an in vitro diagnostic reagents for the quantitative measurement of immunoglobulin G subclass 1-4 in human serum and plasma.

7. Device Performance Characteristics:

The Dimension Vista® IGG 1 and 2 assays were compared to N Antiserum to Human IgG Subclasses 1 and 2 on the BN ProSpec® System. Regression analysis of these results yielded the following equations:

Method Comparison Study
n	Slope	Interceptg/L	CorrelationCoefficient
Dimension Vista® IGG1	129	1.002	-0.165	0.994

Method Comnarison Study

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The Dimension Vista® IGG 3 and 4 assays were compared to N N Latex IgG3 and IgG4 on the BN ProSpec® System. Regression analysis of these results yielded the following equations:

n	Slope	Interceptg/L	CorrelationCoefficient
Dimension Vista® IGG3	142	1.047	-0.002	0.993
Dimension Vista® IGG4	150	1.020	-0.009	0.996

Method Comparison Study

: 上一篇:

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

OCT 2 1 2009

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

Re: K092283

Trade/Device Name: Dimension Vista® IgG Subclass 1 Flex® reagent cartridge Dimension Vista® IgG Subclass 2 Flex® reagent cartridge Dimension Vista® IgG Subclass 3 Flex® reagent cartridge Dimension Vista® IgG Subclass 4 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: DFZ Dated: July 27, 2009 Received: July 29, 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 class II (Special Controls), 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.

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Page 2 - Ms. Kathleen Ann Dray-Lyons

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entifled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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510(k)Number: K092283

Device Name: Dimension Vista® Immunoglobulin G Subclass 1 Flex® reagent cartridge

The IgG1 method is an in vitro diagnostic test for the quantitative Indications for Use: measurement of immunoglobulin G subclass 1 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista® System. Measurements of immunoglobulin G subclass I aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findings.

Prescription use X AND/OR

Over-the-counter use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of in vitro Diagnostic devices (OIVD)

Reena Philip

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safeh

51910 K092283

Page 1 of 4

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510(k)Number: K092283

Device Name: Dimension Vista® Immunoglobulin G Subclass 2 Flex® reagent cartridge

The IgG2 method is an in vitro diagnostic test for the quantitative Indications for Use :measurement of immunoglobulin G subclass 2 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista® System. Measurements of immunoglobulin G subclass 2 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findings.

Prescription use X

AND/OR

Over-the-counter use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of in vitro Diagnostic devices (OIVD)

Reena Philip

ASSEL Barres

Office of In Vitro Diagnostic Device Evaluation and Safely

092283

Page 2 of 4

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510(k)Number: K092283

Device Name: Dimension Vista® Immunoglobulin G Subclass 3 Flex® reagent cartridge

The IgG3 method is an in vitro diagnostic test for the quantitative Indications for Use: measurement of immunoglobulin G subclass 3 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista® System. Measurements of immunoglobulin G subclass 3 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findings.

Prescription use X

AND/OR

Over-the-counter use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of in vitro Diagnostic devices (OIVD)

Page 3 of 4

Reena Philip

Office of in Vitro Diagnostic Device Evaluation and Sufam

092283

{8}------------------------------------------------

510(k)Number: K092283

Device Name: Dimension Vista® Immunoglobulin G Subclass 4 Flex® reagent cartridge

The IgG4 method is an in vitro diagnostic test for the quantitative Indications for Use: measurement of immunoglobulin G subclass 4 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista® System. Measurements of immunoglobulin G subclass 4 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findings.

Prescription use X AND/OR

Over-the-counter use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of in vitro Diagnostic devices (OIVD)

Page 4 of 4

Reena Philip

Office of In Vino Dictions Device Evaluation and 1 tim

092283

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).