DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH

K063610 · Dade Behring, Inc. · DEM · Jan 11, 2007 · Immunology

Device Facts

• Record ID: K063610
• Device Name: DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
• Applicant: Dade Behring, Inc.
• Product Code: DEM · Immunology
• Decision Date: Jan 11, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5130
• Device Class: Class 2

Intended Use

Dimension Vista™ A1AT Flex® reagent cartridge: The A1AT method is an in vitro diagnostic test for the quantitative determination of a - antitrypsin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of a-antitrypsin aid in the diagnosis of cirrhosis of the liver and pulmonary emphysema. Dimension Vista™ Protein 1 Calibrator: PROT1 CAL is an in vitro diagnostic product for the calibration of the a1antitrypsin (A1AT), C3 Complement (C3), C4 Complement (C4), 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 α1-antitrypsin (A1AT), C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), and prealbumin (PREALB) on the Dimension Vista® System.

Device Story

The Dimension Vista A1AT Flex reagent cartridge is an in vitro diagnostic test used on the Dimension Vista System. It measures alpha-1-antitrypsin (A1AT) concentrations in human serum or plasma samples. The device operates via an immunochemical reaction where proteins in the sample form immune complexes with specific antibodies; these complexes scatter light passed through the sample. The intensity of scattered light is proportional to the protein concentration, which is then evaluated against a known standard. The system includes a multi-analyte calibrator and assayed quality controls (L, M, H) to ensure precision and analytical bias assessment. The device is intended for use in clinical laboratory settings by trained personnel. Results assist healthcare providers in diagnosing liver cirrhosis and pulmonary emphysema.

Clinical Evidence

No clinical studies performed. Evidence consists of analytical bench testing: precision (within-lab CV 2.28-3.80%), linearity (0.17-5.20 g/L reportable range), and method comparison against predicate (n=139, slope 1.000, r=0.996). Interference testing performed per CLSI EP7-A.

Technological Characteristics

Immunonephelometry assay. Reagents: rabbit polyclonal antiserum to human A1AT, phosphate buffer, polyethylene glycol. Form factor: liquid reagent cartridge. Connectivity: integrated with Dimension VISTA system. Standardization: traceable to ERM-DA470. Storage: 2-8°C.

Indications for Use

Indicated for quantitative determination of alpha-1-antitrypsin in human serum, heparinized plasma, or EDTA plasma to aid in the diagnosis of adult cirrhosis of the liver and pulmonary emphysema.

Regulatory Classification

Identification

An alpha-1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema.

Predicate Devices

• Dade Behring N Antisera to Human α1-antitrypsin assay (k053072)
• N Protein Standard SL (k012470)
• N/T Protein Control SL (k012468)

Submission Summary (Full Text)

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# 510(k) Summary for Dimension Vista" A1AT Flex® reagent cartridge
Dimension Vista™ Protein 1 Control L, M and H

JAN 1 1 2007

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: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

| 1. | Manufacturer's Name, Address, Telephone, and Contact Person, Date of<br>Preparation: | |
|----|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Manufacturer: | Dade Behring Marburg GmbH<br>Emil-von-Behring Str. 76<br>35041 Marburg, Germany |
| | Contact Information: | Dade Behring Inc.<br>P.O. Box 6101<br>Newark, Delaware 19714-6101<br>Attn: Kathleen Dray-Lyons<br>Tel: [phone]<br>Fax: [phone] |
| | Preparation date: | December 20, 2006 |
| 2. | Device Name: | Dimension Vista™ A1AT Flex® reagent cartridge<br>Dimension Vista™ Protein 1 Calibrator<br>Dimension Vista™ Protein 1 Control L<br>Dimension Vista™ Protein 1 Control M<br>Dimension Vista™ Protein 1 Control H |
| | Classification:<br>Product Code:<br>Panel: | Class II; Class II; Class I<br>DEM; JIX; JJY<br>Immunology (82) and Clinical Chemistry (75) |

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

Dade Behring N Antisera to Human α1-Antitrypsin– Κ053072 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468

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#### Device Descriptions: 4.

### Dimension Vista" A1AT 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 a1antitrypsin (A1AT). C3 complement, C4 complement, 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, liguid, human serum based products containing a1-antitrypsin (A1AT), C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).

#### Device Intended Uses: 5.

### Dimension Vista™ A1AT Flex® reagent cartridge:

The A1AT method is an in vitro diagnostic test for the quantitative determination of aantitrypsin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista System. Measurements of q-antitrypsin aid in the diagnosis of cirrhosis of the liver and pulmonary emphysema.

### Dimension Vista™ Protein 1 Calibrator:

PROT1 CAL is an in vitro diagnostic product for the calibration of the a - antitrypsin (A1AT), C3 complement (C3), C4 complement (C4), Immunoglobulin A (IGA), lmmunoglobulin 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 a1-antitrypsin (A1AT), C3 Complement (C3), C4 Complement (C4), 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" A1AT assay, like Dade Behring N Antisera to Human a1-Antitrypsin is an in vitro diagnostic test for the quantitative measurement of a1-antitrypsin in human serum and plasma.

#### 7. Device Performance Characteristics:

The Dimension Vista™ A1AT assay was compared to the Dade Behring N Antisera to Human a1-antitrypsin assay on the BN ProSpec® System by evaluating serum and plasma samples with concentrations ranging from 0.23 g/L to 4.71 g/L. Regression analysis of these results yielded the following equation.

CUNF II-NTIAL

0000020

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### Method Comparison Study

| Comparative Method | n | Slope | Intercept<br>g/L | Correlation<br>Coefficient |
|------------------------------------------------------|-----|-------|------------------|----------------------------|
| N Antisera to Human<br>α₁-Antitrypsin BN<br>ProSpec® | 139 | 1.000 | 0.070 | 0.996 |

#### 8. Conclusion:

These studies demonstrate correlation and equivalent performance between the Dade
Behring N Antisera to Human α-Antitrypsin assay and the Dimension Vista" A1AT assay.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dade Behring, Inc. JAN 1 1 2007 c/o Ms. Kathleen Dray-Lyons Manager, Regulatory Affairs and Compliance Glasgow Site P.O. Box 6101 Newark, DE 19714

Re: k063610

Trade/Device Name: Dimension Vista™ A1AT 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 866.5130

Regulation Name: Alpha-1-Antitrypsin Immunological Test System Regulatory Class: Class II Product Code: DEM, JIX, JJY Dated: December 1, 2006 Received: December 4, 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 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 vour 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,

ia Chan for
Dr. Robert 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

· K063610

Dimension Vista" A1AT Flex® reagent cartridge
Dimension Vista" Protein 1 Calibrator
Dimension Vista" Protein 1 Calibrator
Dimension Vista" Protein 1 Control Mar
Dimension Vis Device Name:

### Indications for Use:

# Dimension Vista™ A1AT Flex® reagent cartridge:

The A1AT method is an in vitro diagnostic test for the quantitative determination of a - antitrypsin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of a-antitrypsin aid in the diagnosis of cirrhosis of the liver and pulmonary emphysema.

## Dimension Vista™ Protein 1 Calibrator

PROT1 CAL is an in vitro diagnostic product for the calibration of the a1antitrypsin (A1AT), C3 Complement (C3), C4 Complement (C4), 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 α1-antitrypsin (A1AT), C3 Complement (C3), C4 Complement (C4), 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)

m chan

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Office of In Vitro Diagnostic

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510(k) K063610

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