DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH

K061852 · Dade Behring, Inc. · CZW · Sep 22, 2006 · Immunology

Device Facts

• Record ID: K061852
• Device Name: DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH
• Applicant: Dade Behring, Inc.
• Product Code: CZW · Immunology
• Decision Date: Sep 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5240
• Device Class: Class 2

Intended Use

Dimension Vista™ C3 Flex® reagent cartridge: The C3 method is an in vitro diagnostic test for the quantitative measurement of complement C3 in human serum and heparinized plasma on the Dimension Vista™ System. Measurements of C3 are used as an aid in the diagnosis of immunologic disorders associated with complement C3 protein. Dimension Vista™ C4 Flex® reagent cartridge: The C4 method is an in vitro diagnostic test for the quantitative measurement of complement C4 in human serum and heparinized plasma on the Dimension Vista™ System. Measurements of C4 are used as an aid in the diagnosis of immunologic disorders associated with complement C4 protein. Dimension Vista™ Protein 1 Calibrator: Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), and Immunoglobulin M (IGM) on the Dimension Vista™ System. Dimension Vista™ Protein 1 Control L, Dimension Vista™ Protein 1 Control M and Dimension Vista™ Protein 1 Control H: Protein 1 Control L/M/H are for use as an assayed intralaboratory quality controls for the assessment of precision and analytical bias in determination of C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM) methods on the Dimension Vista™ System.

Device Story

Dimension Vista™ C3/C4 Flex® reagent cartridges are in vitro diagnostic reagents for use on the Dimension Vista™ System. System utilizes immunochemical reaction where proteins in human serum/plasma form immune complexes with specific antibodies; complexes scatter light beam passed through sample. Scattered light intensity is proportional to protein concentration. Results evaluated against known calibrator. System intended for clinical laboratory use. Calibrator and controls (L/M/H) are liquid human serum-based products used to calibrate assays and assess precision/analytical bias. Device aids clinicians in diagnosing immunologic disorders by providing quantitative protein measurements.

Clinical Evidence

No clinical data. Performance established via bench testing: precision (CLSI EP5-A2), linearity, analytical sensitivity, and interference studies. Method comparison performed against BN ProSpec system using 116 samples for C3 and 126 samples for C4, showing strong correlation (Passing-Bablock regression).

Technological Characteristics

Immunonephelometric assay; 840nm light source. Reagents: rabbit polyclonal antibodies. Cartridges: 12-well format with barcode identification. Calibrators/Controls: human serum-based. Connectivity: integrated with Dimension Vista System. Standards: CLSI EP5-A2, EP9-A2, EP7-A2; Traceability to CRM 470.

Indications for Use

Indicated for use as an aid in the diagnosis of immunologic disorders associated with complement C3 and C4 proteins in serum and heparinized plasma samples.

Regulatory Classification

Identification

A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

Predicate Devices

• Dade Behring N Antisera to Human Complement Factors (C3c, C4) (k050665)

Submission Summary (Full Text)

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# 510(k) Summary for Dimension Vista™ C3 Flex® reagent cartridge Dimension Vista™ C4 Flex® reagent cartridge Dimension Vista™ Protein 1 Calibrator Dimension Vista™ Protein 1 Control L/M/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.

061852 The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

- 1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:
- Manufacturer: Dade Behring Marburg GmbH Emil-von-Behring Str. 76 D-35001 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: June 29. 2006

- 2. Device Name: Dimension Vista™ C3 Complement Flex® reagent cartridge (C3) Dimension Vista™ C4 Complement Flex® reagent cartridge (C4) Dimension Vista™ Protein 1 Calibrator Dimension Vista™ Protein 1 Control L Dimension Vista™ Protein 1 Control M Dimension Vista™ Protein 1 Control H

| Classification: | Class II; Class II; Class II; Class I |
|-----------------|---------------------------------------------|
| Product Code: | CZW; DBI; JIX; JJY |
| Panel: | Immunology (82) and Clinical Chemistry (75) |

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

050665 Dade Behring N Antisera to Human Complement Factors (C3c, C4) JJ99999 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468

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#### 4. Device Description:

### Dimension Vista™ C3 and C4 Flex® reagent cartridges

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 calibrator 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, Immunoglobulin G and lmmunoqlobulin M (IGM).

# Dimension Vista™ Protein 1 Controls L/M/H

Protein 1 Controls L/M/H are multi-analyte, liquid human serum based products containing C3 Complement, C4 Complement, Immunoglobulin A, Immunoglobulin G and lmmunoglobulin M (IGM).

#### 5. Device Intended Use:

# Dimension Vista™ C3 Flex® Reagent Cartridge:

The C3 method is an in vitro diagnostic test for the quantitative measurement of complement C3 in human serum and heparinized plasma on the Dimension Vista™ System. Measurements of C3 are used as an aid in the diagnosis of immunologic disorders associated with complement C3 protein.

# Dimension Vista™ C4 Flex® Reagent Cartridge:

The C4 method is an in vitro diagnostic test for the quantitative measurement of complement C4 in human serum and heparinized plasma on the Dimension Vista™ System. Measurements of C4 are used as an aid in the diagnosis of immunologic disorders associated with complement C4 protein.

### Dimension Vista™ Protein 1 Calibrator:

Protein 1 Calibrator is an in vitro diagnostic product for the calibration of C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM) methods on the Dimension Vista " System.

# Dimension Vista™ Protein 1 Control L/M/H:

Protein 1 Controls L/M/H are for use as an assayed intralaboratory quality controls for the assessment of precision and analytical bias in determination of C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM) on the Dimension Vista™ System.

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

The Dimension Vista™ C3 and C4 Flex reagent cartridge. Dimension Vista™ Protein 1 Calibrator (K051087) and Dimension Vista™ Protein 1 Control L/M/H (K051087) are substantially equivalent to the Dade Behring N Antisera to Human Complement Factors (C3c, C4) assays (K050665), N Protein Standard SL (K012470) and N/T Protein Control SL (K012468), respectively. The Dimension Vista™ C3 and C4 assays, like the N Antisera to Human Complement Factors (C3c, C4) assays are in vitro diagnostic reagents

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# SEP 2 2 2006

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

Re:´k061852´´´´ ´ ´ ´ ´ ´

Trade/Device Name: Dimension Vista™ C3 Flex® reagent cartridge Dimension Vista™ C4 Flex® reagent cartridge Dimension Vista™ Protein 1 Calibrator Dimension Vista™ Protein 1 Control L, Dimension Vista™ Protein 1 Control M and Dimension Vista™ Protein 1 Control H Regulation Number: 21 CFR 866.5240 Regulation Name: Complement Components Immunological Test System Regulatory Class: Class II Product Code: CZW, DBI, JIX, JJY Dated: June 29, 2006

Dear Ms. Dray-Lyons:

Received: June 30, 2006

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);

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labeling (21 CFR Part 801); 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.

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 Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 R. Becker

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 Statement

Device Name: Dimension Vista™ C3 Flex® reagent cartridge Dimension Vista™ C4 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

# Indications for Use:

Dimension Vista™ C3 Flex® reagent cartridge:

The C3 method is an in vitro diagnostic test for the quantitative measurement of complement C3 in human serum and heparinized plasma on the Dimension Vista™ System. Measurements of C3 are used as an aid in the diagnosis of immunologic disorders associated with complement C3 protein.

## Dimension Vista™ C4 Flex® reagent cartridge:

The C4 method is an in vitro diagnostic test for the quantitative measurement of complement C4 in human serum and heparinized plasma on the Dimension Vista™ System. Measurements of C4 are used as an aid in the diagnosis of immunologic disorders associated with complement C4 protein.

### Dimension Vista™ Protein 1 Calibrator:

Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), and Immunoglobulin M (IGM) on the Dimension Vista™ System.

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

Protein 1 Control L/M/H are for use as an assayed intralaboratory quality controls for the assessment of precision and analytical bias in determination of C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM) methods 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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Office of in Vitro Dlagnostic Device Evaluation and Safety

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