DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH

K063655 · Dade Behring, Inc. · CHN · Feb 15, 2007 · Immunology

Device Facts

• Record ID: K063655
• Device Name: DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH
• Applicant: Dade Behring, Inc.
• Product Code: CHN · Immunology
• Decision Date: Feb 15, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5210
• Device Class: Class 2

Intended Use

The CER method is an in vitro diagnostic test for the quantitative determination of Ceruloplasmin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista System. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders. PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin (PREALB) methods on the Dimension Vista® System. 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), ceruloplasmin (CER), immunoglobulin A (IGA), immunoglobulin G (IGG), Immunoglobulin M (IGM) and prealbumin (PREALB) on the Dimension Vista® System.

Device Story

The Dimension Vista CER Flex reagent cartridge is an in vitro diagnostic assay for quantitative ceruloplasmin measurement in human serum/plasma. It utilizes an immunochemical reaction where proteins in the sample form immune complexes with specific antibodies; these complexes scatter light. The intensity of scattered light is proportional to protein concentration. The system evaluates results by comparing them against a known standard. The device is used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing copper metabolism disorders. The system includes associated liquid, human serum-based calibrators and assayed quality controls to ensure analytical precision and bias assessment.

Clinical Evidence

Bench testing only. Precision study (20 days, duplicate analysis) showed within-lab CVs ranging from 1.78% to 5.22%. Linearity confirmed across 0.07 to 3.40 g/L range (slope 1.018, r=1.000). Method comparison against predicate (n=130) yielded slope 1.009, intercept 0.008, r=0.994. Interference testing confirmed no significant bias (±10%) for common endogenous substances, RF up to 685 IU/mL, and total protein up to 127 g/L. Matrix comparison (serum vs. plasma) showed high agreement (r ≥ 0.998).

Technological Characteristics

Reagent cartridge contains reaction buffer (phosphate buffer, polyethylene) and rabbit antiserum to human ceruloplasmin. Quantitative nephelometric sensing principle. Energy source: system-integrated light source for scattering. Dimensions/form factor: multi-well reagent cartridge. Connectivity: system-specific (Dimension Vista®). Sterilization: not specified. Software: automated system-controlled analysis.

Indications for Use

Indicated for the quantitative determination of ceruloplasmin in human serum, heparinized plasma, or EDTA plasma to aid in the diagnosis of copper metabolism disorders. For prescription use only.

Regulatory Classification

Identification

A ceruloplasmin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ceruloplasmin (copper-transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

Predicate Devices

• Dade Behring N Antisera to Human Ceruloplasmin (k053074)
• 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™ CER 510(k) Notification

FEB 1 5 2007

# 510(k) Summary for Dimension Vista" CER Flex reagent cartridge Dimension Vista™ Protein 1 Calibrator Dimension Vista" Protein 1 Control L, M and H

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: 1003655

- Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. 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: December 7, 2006

- Dimension Vista" CER Flex® reagent cartridge
Dimension Vista™ Protein 1 Calibrator 2. Device Name: Dimension Vista" Protein 1 Control L Dimension Vista" Protein 1 Control M
Dimension Vista" Protein 1 Control M
Classification: Class II; Class II; Class I Product Code: DDB; JIX; JJY Panel: Immunology (82) and Clinical Chemistry (75)

#### 3. Identification of the Legally Marketed Devices:

Dade Behring N Antisera to Human Ceruloplasmin~ K053074 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468

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

#### 4. Device Descriptions:

## Dimension Vista™ CER 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, ceruloplasmin (CER), immunoglobulin A (IGA), 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, ceruloplasmin (CER), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).

#### 5. Device Intended Uses:

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

The CER method is an in vitro diagnostic test for the quantitative determination of ceruloplasmin in human serum, heparinized plasma on the Dimension Vista System. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.

## Dimension Vista™ Protein 1 Calibrator:

PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Immunoglobulin A (IGA), 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), ceruloplasmin (CER), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) on the Dimension Vista "System.

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

The Dimension Vista" CER assay, like Dade Behring N Antisera to Human Ceruloplasmin is an in vitro diagnostic test for the quantitative measurement of Ceruloplasmin in human serum and plasma.

#### 7. Device Performance Characteristics:

The Dimension Vista" CER assay was compared to the Dade Behring N Antisera to Human Ceruloplasmin assay on the BN ProSpec System by evaluating serum and plasma samples with concentrations ranging from 0.09 g/L to 2.20 g/L. Regression analysis of these results yielded the following equation.

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| Comparative Method | n | Slope | Intercept<br>g/L | Correlation<br>Coefficient |
|-----------------------------------------------------|-----|-------|------------------|----------------------------|
| N Antisera to Human<br>Ceruloplasmin on BN ProSpec® | 130 | 1.009 | 0.008 | 0.994 |

### Method Comparison Study

#### 8. Conclusion:

These studies demonstrate correlation and equivalent performance between the Dade
Behring N Antisera to Human Ceruloplasmin assay and the Dimension Vista" CER assay

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular fashion around the eagle. The text is in all capital letters and is relatively small compared to the eagle symbol. The logo is black and white.

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: k063655

Trade/Device Name: Dimension Vista™ Ceruloplasmin 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 866.5210 Regulation Name: Ceruloplasmin Immunological Test System Regulatory Class: Class II Product Code: CHN, JIX, JJY Dated: December 7, 2006 Received: December 8, 2006

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 sset 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 Z. Beebech

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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Dimension Vista™ CEF

# Indications Statement

K063655

Device Name:

Dimension Vista™ CER Flex® reagent cartridge " Protein 1 Calibrator Dimension Vista" Protein 1 Calibrator Dimension Vista™ Protein 1 Control M Dimension Vista™ Protein 1 Control H

### Indications for Use:

# Dimension Vista™ CER Flex® reagent cartridge:

The CER method is an in vitro diagnostic test for the quantitative determination of Ceruloplasmin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista System. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.

## Dimension Vista™ Protein 1 Calibrator

PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Immunoglobulin A (IGA), 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), ceruloplasmin (CER), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) on the Dimension Vista® System.

Prescription Use × (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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