DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR

K073561 · Dade Behring, Inc. · CFN · Feb 26, 2008 · Immunology

Device Facts

• Record ID: K073561
• Device Name: DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR
• Applicant: Dade Behring, Inc.
• Product Code: CFN · Immunology
• Decision Date: Feb 26, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

The IGG method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin G in human serum, heparinized plasma and cerebrospinal fluid (CSF) on the Dimension Vista® System. Measurements of IgG aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Device Story

Dimension Vista System IGG Flex reagent cartridge performs in vitro quantitative measurement of immunoglobulin G (IgG) in human serum, heparinized plasma, and CSF. Device utilizes immunochemical reaction where proteins in body fluids form immune complexes with specific antibodies; complexes scatter light beam passed through sample. Intensity of scattered light is proportional to protein concentration; result evaluated by comparison with known standard. Used in clinical laboratory settings by trained personnel. Output provides quantitative IgG concentration to assist clinicians in diagnosing abnormal protein metabolism and immune system function. System includes Protein 1 Calibrator and Protein 3 Control for calibration and quality control assessment of precision and analytical bias.

Clinical Evidence

Bench testing only. Studies demonstrated correlation and equivalent performance between the modified Dimension Vista IGG assay and the predicate N Antisera to Human IGG for the CSF sample matrix.

Technological Characteristics

Nephelometric assay; rabbit polyclonal antisera; liquid reagent cartridges; lyophilized controls. Calibrator traceable to ERM® DA 470. Measuring range: 1.4–40.0 g/L (serum/plasma), 4.4–123 mg/L (CSF). Connectivity: Dimension Vista® Analyzer (k051087).

Indications for Use

Indicated for quantitative measurement of immunoglobulin G in human serum, heparinized plasma, and cerebrospinal fluid (CSF) to aid in the diagnosis of abnormal protein metabolism and immune deficiency.

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

• N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) (k042735)
• Dimension Vista® System Immunoglobulin G Flex® reagent cartridge (k051087)
• Dimension Vista® System Protein 1 Calibrator (k071980)
• Dimension Vista® System Protein 3 Control (k072435)

Submission Summary (Full Text)

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K073561

### 510 (k) Summary

This summary of 5109k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

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

FEB 26 2002

Manufacturer: Dade Behring Marburg GmbH Emil-von-Behring Str. 76 35041 Marburg, Germany

Contact Information: Helen M. Lee Dade Behring Inc. P.O. Box 6101 Newark, DE 19714-6101 302.631.8706 302.631.6299 (fax)

Date of Preparation: November 28, 2007

#### Name of Products: 2.

Dimension Vista® System IGG Flex® reagent cartridge Dimension Vista® System Protein 1 Calibrator Dimension Vista® System Protein 3 Control

### 3. Identification of the Legally marketed Device:

N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) k042735 Dimension Vista® System Immunoglobulin G Flex® reagent cartridge Dimension Vista® System Protein 1 Calibrator (k071980) Dimension Vista® System Protein 3 Control (k072435)

### 4. Device Descriptions:

Dimension Vista® System Immunoglobulin G 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.

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Dimension Vista® System Protein 1 Calibrator PROT1 CAL is a multi-analyte, liquid human serum based product containing:

| α₁-Acid Glycoprotein | Immunoglobulin G |
|----------------------|------------------------------|
| α₁-Antitrypsin | Immunoglobulin G Subclass 1 |
| β₂-Microglobulin | Immunoglobulin G Subclass 2 |
| C3 Complement | Immunoglobulin G Subclass 3 |
| C4 Complement | Immunoglobulin G Subclass 4 |
| Ceruloplasmin | Immunoglobulin M |
| Haptoglobin | Prealbumin |
| Hemopexin | Retinol Binding Protein |
| Homocysteine | soluble Transferrin Receptor |
| Immunoglobulin A | Transferrin |
| Immunoglobulin E | |

Dimension Vista® System Protein 3 Control PROT3 CON is a multi-analyte, lyophilized, polygeline and rabbit albumin based product containing:

a -Microglobulin Immunoglobulin G Albumin

#### Device Intended Uses: 5.

Dimension Vista Immunoglobulin G Flex reagent cartridge

The IGG method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin G in human serum, heparinized plasma and cerebrospinal fluid (CSF) on the Dimension Vista System. Measurements of IgG aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

### Dimension Vista® System Protein 1 Calibrator

PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista System for:

a -Acid Glycoprotein (A1AG) Immunoglobulin G (IGG) [serum/plasma] and Immunoglobulin G (IGG-C) [cerebrospinal fluid] a -Antitrypsin (A1AT) Immunoglobulin G Subclass 1 (IGG1) B_-Microglobulin (B2MIC) Immunoglobulin G Subclass 2 (IGG2) C3 Complement (C3) Immunoglobulin G Subclass 3 (IGG3) C4 Complement (C4) Immunoglobulin G Subclass 4 (IGG4)

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Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoqlobulin E (IGE) Immunoqlobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)

### Dimension Vista® System Protein 3 Control

PROT3 CON is an assayed quality control for the assessment of precision and analytical bias on the Dimension Vista System in quantitative determination of:

a -Microglobulin (A1MIC) Immunoglobulin G (IGG-C)* Microalbumin (MALB) specialty Albumin (sALB) *

* For cerebrospinal fluid (CSF)

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

The N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) was determined to be substantially equivalent in 510(k) Premarket Notification k042735 and is the predicate for adding the CSF sample matrix to the Dimension Vista® IGG assay.

The current Dimension Vista® IGG Flex® reagent cartridge was originally determined to be substantially equivalent in 510(k) Premarket Notification k051087. The subsequent assay modifications are described in this submission. The changes include: adjustment of the measuring range: reagent stability (both on board and open well), as well as other minor changes to the IFU. The operating principle and reagent composition have not changed. For your convenience, the sections with changes have been underlined in the Draft Instructions for Use included in this submission.

Dimension Vista® Protein 1 Calibrator, modified to include IGG-C (IGG in CSF), is substantially equivalent in intended use to the current Dimension Vista® Protein 1 Calibrator (k071980). The modified Dimension Vista® Protein 1 Calibrator, like the current product, is intended to be used for the calibration of human protein assays on the Dimension Vista® System.

Dimension Vista® System Protein 3 Control modified to include IGG-C (IGG in CSF), is substantially equivalent in Intended Use to the current Dimension Vista® System Protein 3 Control (K072435). The modified Dimension Vista® System Protein 3 Control like the current product is intended to be used as an assayed intralaboratory quality control on the Dimension Vista® System.

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### 7. Conclusion:

The studies included in this submission demonstrate correlation to and equivalent performance between the predicate N Antisera to Human IGG for CSF sample matrix.

The modified Dimension Vista® System IGG assay, modified Dimension Vista® System Protein 1 The modified Dimension Vista® System Protein 3 Control are substantially equivalent to Callbrator and modified Dimender Vista Crossed upon the demonstrated correlation and the information above.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular pattern.

FEB 26 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dade Behring, Inc. c/o Ms. Helen M. Lee Regulatory Affairs and Compliance Manager P.O. Box 6101, MS514 Newark, DE 19714-6101

Re: k073561

Trade/Device Name: Dimension Vista® System Immunoglobulin G Flex® Reagent Cartridge Dimension Vista® System Protein 1 Calibrator Dimension Vista® System Protein 3 Control Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, E immunological test system Regulatory Class: Class II Product Code: CFN, JIX, JJY Dated: February 18, 2008 Received: February 19, 2008

Dear Ms. Lee:

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 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

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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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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 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. 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,

Robert H. Bockel

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 for Use Statement

# 510(k) Number (if known): 长۵ 735 /

### Device Name:

Dimension Vista® System Immunoglobulin G Flex® Reagent cartridge

### Indications for Use:

The IGG method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin G in human serum, heparinized plasma and cerebrospinal fluid (CSF) on the Dimension Vista® System. Measurements of IgG 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) 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)

Mana In Chan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

53002 K073561

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## Indications for Use Statement

# 510(k) Number (if known):

Device Name:

Dimension Vista® System Protein 1 Calibrator

#### Indications for Use:

PROT 1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista System for:

a1-Acid Glycoprotein (A1AG)

a1-Antitrypsin (A1AT) B2-Microglobulin (B2MIC) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoglobulin E (IGE)

Immunoglobulin G (IGG) [serum/plasma] and Immunoglobulin G (IGG-C) [cerebrospinal fluid] Immunoglobulin G Subclass 1 (IGG1) Immunoglobulin G Subclass 2 (IGG2) Immunoglobulin G Subclass 3 (IGG3) Immunoglobulin G Subclass 4 (IGG4) Immunoglobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)

Prescription Use (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)

ia m Chan

DIVISION: SIGN-OFF

Office of in Vitro Diagnostic Device Evaluation and Safety

- a Ko73561

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### Indications for Use Statement

Ko73561 510(k) Number (if known):

Device Name:

Dimension Vista® System Protein 3 Control

Indications for Use:

PROT3 CON is an assayed, low level intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the determination of a1-Microglobulin (A1MIC), specialty Albumin (sALB)*, Immunoglobulin G (IGG -C)* and Microalbumin (MALB).

* For Cerebrospinal fluid (CSF)

Prescription Use _ × (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)

Mana m Chan

Division Sign-Off

് Office of In Vitro Diagnostic Device Evaluation and Safety

5130 K073541