DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID

K090594 · Siemens Healthcare Diagnostics · CFN · Apr 29, 2009 · Immunology

Device Facts

• Record ID: K090594
• Device Name: DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID
• Applicant: Siemens Healthcare Diagnostics
• Product Code: CFN · Immunology
• Decision Date: Apr 29, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

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. 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 Story

Dimension Vista IGA and IGM Flex reagent cartridges are in vitro diagnostic assays for use on the Dimension Vista System. Input: human serum or heparinized plasma samples. Principle: immunochemical reaction between proteins in sample and specific antibodies forms immune complexes; complexes scatter light beam. Output: intensity of scattered light, proportional to protein concentration, evaluated against known calibrator/standard. Used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing abnormal protein metabolism and immune system function. Benefits: provides quantitative data for clinical decision-making regarding patient immune status.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2 (n=80). Linearity evaluated per CLSI EP06-A. Limit of Quantitation (LoQ) determined per CLSI EP17-A (0.063 g/L for IgA; 0.053 g/L for IgM). Method comparison performed against predicate on BN ProSpec® System (n=28 for IgA, n=26 for IgM) showing high correlation (r=0.992 for IgA, r=0.989 for IgM).

Technological Characteristics

Reagents: rabbit polyclonal antiserum, phosphate buffer, polyethylene glycol. Methodology: nephelometry. Instrument: Dimension Vista® Integrated System. Standardization: traceable to IFCC/BCR/CAP CRM 470. Reportable range: 0.063–7.50 g/L (IgA); 0.053–6.40 g/L (IgM).

Indications for Use

Indicated for quantitative measurement of Immunoglobulin A (IgA) and Immunoglobulin M (IgM) in human serum and heparinized plasma to aid in diagnosis of abnormal protein metabolism and immune deficiency. For prescription use.

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

Reference Devices

• Dimension Vista Integrated System® (k051087)
• k061338
• k061845

Submission Summary (Full Text)

{0}------------------------------------------------

## 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: [phone] Fax: [phone]
Preparation date: April 9, 2009

The assigned 510(k) number is:

1.

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.

{1}------------------------------------------------

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

:

{2}------------------------------------------------

#### 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<br>(95%CI) | Intercept<br>(95%CI) | Correlation<br>Coefficient<br>r | Correlation<br>Coefficient<br>r2 |
|-------------------------|----|-------------------------|-------------------------|---------------------------------|----------------------------------|
| Dimension Vista®<br>IgA | 28 | 1.000<br>(1.000, 1.000) | 0.000<br>(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<br>(95%CI) | Intercept<br>(95%CI) | Correlation<br>Coefficient<br>r | Correlation<br>Coefficient<br>r2 |
|-------------------------|----|-------------------------|--------------------------|---------------------------------|----------------------------------|
| Dimension Vista®<br>IgM | 26 | 1.023<br>(0.967, 1.122) | 0.004<br>(-0.004, 0.008) | 0.989 | 0.979 |

### Method Comparison Study

{3}------------------------------------------------

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

{4}------------------------------------------------

### 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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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

{5}------------------------------------------------

# 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

{6}------------------------------------------------

# 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