DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG

K092283 · Siemens Healthcare Diagnostics · DFZ · Oct 21, 2009 · Immunology

Device Facts

• Record ID: K092283
• Device Name: DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG
• Applicant: Siemens Healthcare Diagnostics
• Product Code: DFZ · Immunology
• Decision Date: Oct 21, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

Reagent cartridges for Dimension Vista System; measure IgG subclasses (1-4) in human serum/plasma. Principle: immunochemical reaction forming immune complexes; IgG1/2 use direct nephelometry; IgG3/4 use particle-enhanced nephelometry. Scattered light intensity proportional to protein concentration. Used in clinical laboratories; operated by trained personnel. Output: quantitative concentration values. Results assist clinicians in diagnosing plasma cell antibody forming abnormalities. Benefits: automated, rapid quantitative assessment of IgG subclasses compared to manual methods.

Clinical Evidence

Bench testing only. Performance validated via precision (CLSI EP5-A2), linearity (EP6-A), and method comparison (EP9-A2) against predicate devices using 129-150 patient samples. Correlation coefficients (r2) ranged from 0.934 to 0.988. Interference testing (EP7-A2) confirmed bias <10% for common endogenous/exogenous substances. Reference intervals validated per CLSI C28-A2.

Technological Characteristics

Nephelometric assay; IgG1/2 use sheep polyclonal antisera; IgG3/4 use polystyrene particles coated with sheep polyclonal antisera. Reagents are liquid, ready-to-use in plastic cartridges. Energy source: light scattering measurement. Connectivity: integrated with Dimension Vista System. Software: automated processing on host system.

Indications for Use

Indicated for quantitative measurement of IgG subclasses 1, 2, 3, and 4 in human serum, heparinized plasma, and EDTA plasma to aid in the diagnosis of plasma cell antibody-forming abnormalities.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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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 GmbH<br>Emil von Behring Str. 76<br>Marburg, 35041 Germany |
|---------------|---------------------------------------------------------------------------------------|
|---------------|---------------------------------------------------------------------------------------|

Siemens Healthcare Diagnostics Contact Information: P.O. Box 6101 Newark, Delaware 19714-6101 Attn: Kathleen Dray-Lyons Tel: [phone] Fax: [phone]

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:

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.

## Dimension Vista® IGG3 Flex® reagent cartridge:

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.

## Dimension Vista® IGG4 Flex® reagent cartridge:

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.

#### 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 | Intercept<br>g/L | Correlation<br>Coefficient | |
| 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 | Intercept<br>g/L | Correlation<br>Coefficient | |
|-----------------------|-------|------------------|----------------------------|-------|
| Dimension Vista® IGG3 | 142 | 1.047 | -0.002 | 0.993 |
| Dimension Vista® IGG4 | 150 | 1.020 | -0.009 | 0.996 |

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### Method Comparison Study

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: 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 [phone] or [phone] 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

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### 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