DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH

K063425 · Dade Behring, Inc. · DGC · Feb 15, 2007 · Immunology

Device Facts

• Record ID: K063425
• Device Name: DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH
• Applicant: Dade Behring, Inc.
• Product Code: DGC · Immunology
• Decision Date: Feb 15, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Dimension Vista™ IGE Flex® reagent cartridge: The IGE method is an in vitro diagnostic test for the quantitative determination of Immunoglobulin E in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of IGE aid in the diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings. Dimension Vista™ Protein 1 Calibrator: PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 complement (C3), C4 complement (C4), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin (PREALB) methods on the Dimension Vista® System. Dimension Vista™ Protein 1 Controls L, M and H: PROT1 CON L, M, and H are assayed intra-laboratory quality controls for assessment of precision and analytical bias in the determination of C3 complement (C3), C4 complement (C4), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin (PREALB) methods on the Dimension Vista® System.

Device Story

The Dimension Vista IGE Flex reagent cartridge is an in vitro diagnostic assay for the Dimension Vista System. It utilizes an immunochemical reaction where proteins in human serum or plasma samples form immune complexes with specific antibodies. These complexes scatter light; the intensity of scattered light is proportional to the protein concentration. The system evaluates results by comparing them against a known standard (Protein 1 Calibrator). Protein 1 Controls (L, M, H) are used to assess precision and analytical bias. The device is intended for use in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing IgE-mediated allergic disorders.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2 (repeatability ≤3.5%, within-lab ≤7.0%). Linearity confirmed across 18-1150 IU/mL range (R=0.996). Method comparison against predicate (n=120) showed high correlation (r=0.999, slope 1.041). Interference testing (CLSI EP7-A2) showed <9% bias for common endogenous substances. No clinical diagnostic sensitivity/specificity studies performed.

Technological Characteristics

Immunonephelometric assay using polystyrene particles coated with mouse monoclonal anti-human IgE. Reagents include phosphate buffer, polyethylene glycol, and sorbitan monolaureate. System: Dimension Vista® automated analyzer. Traceability: 2nd IRP 75/502. Reportable range: 18-1150 IU/mL. Analytical sensitivity: 0.953 IU/mL. Limit of detection: 3.6 IU/mL.

Indications for Use

Indicated for the quantitative determination of Immunoglobulin E (IgE) in human serum, heparinized plasma, or EDTA plasma to aid in the diagnosis of IgE-mediated allergic disorders in conjunction with other clinical findings. Applicable to all patient populations (neonates, infants, children, and adults).

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

• Dade Behring N Latex IgE mono assay (k991787)
• Dade Behring N Protein Standard SL (k012470)
• Dade Behring N/T Protein Control SL (k012468)

Submission Summary (Full Text)

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Dade Behring Inc. Dimension Vista™ IGE 510(k) Notification

# 510(k) Summary for Dimension Vista" Dimension Vista™ Protein 1 Control L, M and H

FEB 1 5 2007

000104

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: K063425

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

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

- Contact Information: Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714-6101 Attn: Kathleen Dray-Lyons Tel: [phone] Fax: [phone]
Preparation date: November 9, 2006

- Dimension Vista" IGE Flex® reagent cartridge
Dimension Vista" Protein 1 Calibral or
Dimension Vista " Protein 1 Controllor
Dimension Vista " Protein 1 Control II M
Dimension 2. Device Name:
Classification: Class II; Class II; Class I Product Code: DGC; JIX; JJY Panel: Immunology (82) and Clinical Chemistry (75)

#### ldentification of the Legally Marketed Device: 3.

Dade Behring N Latex IgE mono- K991787 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468

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Dade Behring Inc. Dimension Vista™ IGE 510(k) Notification

#### 4. Device Description:

### Dimension Vista" IGE 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.

### Dimension Vista " Protein 1 Calibrator

Protein 1 Calibrator is a multi-analyte, liquid, human serum based product containing C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).

### Dimension Vista" Protein 1 Control L. M and H

Protein 1 Control L, M and H are multi-analyte, liquid, human serum based products containing C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).

#### 5. Device Intended Use:

### Dimension Vista™ IGE Flex® reagent cartridge:

The IGE method is an in vitro diagnostic test for the quantitative determination of Immunoglobulin E in human serum, heparinized plasma or EDTA plasma on the Dimension Vista System. Measurements of IGE aid in the diagnosis of the liated allergic disorders in conjunction with other clinical findings.

### Dimension Vista™ Protein 1 Calibrator:

PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 complement (C3), C4 complement (C4), Immunoglobulin A (IGA), Immunoglobulin E (IGE), immunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin (PREALB) methods on the Dimension Vista® System.

### Dimension Vista™ Protein 1 Control L, M and H:

PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) on the Dimension Vistas System.

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

The Dimension Vista™ IGE assay, like the Dade Behring N Latex IgE mono assay is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin E in human serum and plasma.

#### 7. Device Performance Characteristics:

The Dimension Vista ™ IGE assay was compared to the Dade Behring N Latex IgE mono assay on the BN ProSpec® System by eveluating serum and plasma samples with concentrations ranging from 18.2 IU/mL to 1126.5 IU/mL. Regression analysis of these results yielded the following equation.

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| 1 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 1<br>Method Comparison Study | | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|-------|-----------|-------|
| | | | Intercept | |
| N Latex IgE mono on the<br>BN ProSpec® | 120 | 1.041 | 0.151 | 0 999 |

# Table 3

#### 8. Conclusion:

These studies demonstrate correlation and equivalent performance between the Dade
Behring N Latex IgE mono assay and the Dimension Vista " IGE assay.

.

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Image /page/3/Picture/1 description: The image shows a circular seal or logo. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle or bird-like figure with flowing lines, possibly representing movement or flight.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dade Behring Inc. c/o Ms. Kathleen Dray-Lyons Regulatory Affairs and Compliance Manager Glasgow Site P.O. Box 6101 Newark, DE 19714-6101

FEB 1 5 2007

Re: k063425

Trade/Device Name: Dimension Vista™ IgE Flex reagent cartridge Dimension Vista™ Protein 1 Calibrator Dimension Vista™ Protein 1 Control L Dimension Vista™ Protein 1 Control M Dimension Vista™ Protein 1 Control H

Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulin A, G, M, D and E Immunological Test System Regulatory Class: Class II Product Code: DGC, JIX, JJY Dated: January 10, 2007 Received: January 11, 2007

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 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

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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 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). 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 yours,

Robert H. Becker Jr.

Robert L. Becker, Jr., M.D., PH. 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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Dimension Vista™ IGF

## Indications Statement

K063425

Device Name:

Dimension Vista™ IGE Flex® reagent cartridge Dimension Vista _ IGE Flex reagent ca
Dimension Vista _ Protein 1 Calibral L.
Dimension Vista _ Protein 1 Calibral L.
Dimension Vista _ Protein 1 Control M.
Dimension Vista Dimension Vista

Indications for Use:

# Dimension Vista™ IGE Flex® reagent cartridge:

The IGE method is an in vitro diagnostic test for the quantitative determination of Immunoglobulin E in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of IGE aid in the diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings.

### Dimension Vista™ Protein 1 Calibrator

PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin (PREALB) methods on the Dimension Vista® System.

# Dimension Vista™ Protein 1 Control L. M and H

PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM), and prealbumin (PREALB) on the Dimension Vista® System.

Prescription Use X (Per 21 CFR 801 Subpart D) Over-The-Counter-Use_ (21 CFR 801)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)_________ Ko 63425

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