DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY

K061338 · Dade Behring, Inc. · CFN · Jul 6, 2006 · Immunology

Device Facts

• Record ID: K061338
• Device Name: DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY
• Applicant: Dade Behring, Inc.
• Product Code: CFN · Immunology
• Decision Date: Jul 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

Dimension Vista™ IGA Flex® reagent cartridge: The IgA method is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin A in human serum and heparinized plasma on the Dimension Vista™ System. Measurements of IgA aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. Dimension Vista™ Protein 1 Calibrator: The PROT1 CAL is an in vitro diagnostic product for the calibration of Immunoglobulin A (IGA) and Immunoglobulin G (IGG) methods on the Dimension Vista™ System. Dimension Vista™ Protein 1 Control L/M/H: For use as an assayed intralaboratory quality control for assessment of precision and analytical bias in the determination of Immunoglobulin A (IGA) and Immunoglobulin G (IGG) on the Dimension Vista™ System.

Device Story

The Dimension VISTA™ IgA assay is an in vitro diagnostic test for quantitative measurement of immunoglobulin A in human serum and plasma. The device utilizes nephelometry; proteins in the sample form immune complexes with rabbit polyclonal antibodies, scattering a light beam. The intensity of scattered light is proportional to IgA concentration. The system compares the result against a standard of known concentration. The device is used in clinical laboratory settings on the Dimension VISTA™ system. Healthcare providers use the quantitative output to assess protein metabolism and immune function, aiding in the diagnosis of related clinical conditions. The system includes reagent cartridges, calibrators, and quality controls sold separately.

Clinical Evidence

Bench testing only. Performance evaluated via precision studies (CLSI EP5-A2), linearity (0.21–9.32 g/L), and interference testing (CLSI EP7-A). Method comparison against the predicate using 100 samples (50 serum, 50 plasma) showed high correlation (r=0.998, slope 1.022). No clinical data provided.

Technological Characteristics

Nephelometric assay using rabbit polyclonal anti-human IgA antibodies. Reagents include reaction buffer with phosphate and polyethylene glycol. Reportable range 0.25–7.5 g/L. Traceable to IFCC/BCR/CAP CRM 470. Storage 2-8°C. Designed for use on the Dimension VISTA™ automated system.

Indications for Use

Indicated for quantitative measurement of immunoglobulin A in human serum and plasma to aid in the diagnosis of abnormal protein metabolism and immune deficiency. Intended for prescription use only.

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 Antisera to Human IgA (K042735)
• 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™ IGA Assay

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: _ < 06 / 33 8

- Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. Preparation:
- Dade Behring Inc. Manufacturer: P.O. Box 6101 Newark, Delaware 19714-6101 Contact Information: Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714-6101 Attn: Kathleen Dray-Lyons Tel: [phone] Fax: [phone] June 22, 2006 Preparation date: Dimension Vista™ IGA Flex® reagent cartridge Device Name: Dimension Vista™ Protein 1 Calibrator Dimension Vista™ Protein 1 Control L Dimension Vista™ Protein 1 Control M Dimension Vista™ Protein 1 Control H ﺍﻟﻤﺮﺍﺟﻊ

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

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

Dade Behring N Antisera to Human IgA (K042735) Dade Behring N Protein Standard SL (K012470) Dade Behring N/T Protein Control SL (K012468)

#### 4. Device Description:

2.

### Dimension Vista™ IGA 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 calibrator of known concentration.

000021

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### Dimension Vista™ Protein 1 Calibrator

Protein 1 Calibrator is a liquid, human serum based product containing Immunoglobulin A and Immunoqlobulin G.

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

Protein Controls L, M and H are multi-analyte, liquid human serum based product containing Immunoglobulin A and Immunoglobulin G.

#### 5. Device Intended Use:

#### Dimension Vista™ IgA Flex® Reagent Cartridge:

The IgA method is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin A in human serum and heparinized plasma on the Dimension Vista™ System. Measurements of IgA aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

### Dimension Vista™ Protein 1 Calibrator:

The PROT1 CAL is an in vitro diagnostic product for the calibration of Immunoglobulin A (IGA) and Immunoglobulin G (IGG) methods on the Dimension Vista™ System.

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

For use as an assayed intralaboratory quality control for assessment of precision and analytical bias in the determination of Immunoglobulin A (IGA) and Immunoglobulin G (IGG) on the Dimension Vista™ System.

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

The Dimension Vista™ IGA 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 IgA assay (K042735), N Protein Standard SL (K012470) and N/T Protein Control SL (K012468) respectively. The Dimension Vista™ IGA assay, like the N Antisera to Human IgA assay is an in vitro diagnostic reagent for the quantitative measurement of Immunoglobulin A in human serum and plasma.

#### 7. Device Performance Characteristics:

The Dimension Vista™ IgA assay was compared to N Antiserum to Human IgA on the BN ProSpec System by evaluating 50 serum and 50 plasma samples with concentrations ranging from 0.276 to 6.864 g/L. Regression analysis of these results yielded the following equations:

### Method Comparison Study

| Dimension Vista™ | 100 | 1.022 | -0.036 | 0.998 |
|------------------|-----|-------|--------|-------|
| | | | | |

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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 and Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted as a stylized design with flowing lines. The logo also includes the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL - 6 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: k061338

Trade/Device Name: Dimension VISTA™ IgA Flex Reagent Cartridge Assay Dimension VISTA™ Protein 1 Calibrator Dimension VISTATM Protein 1 Control L, Control M and Control H Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, E Immunological Test System Regulatory Class: Class II Product Code: CFN, JJY, JIX Dated: May 12, 2006 Received: May 15, 2006

Dear Ms. Dray-Lyons:

We have reviewed your Scction 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 Cosmelic 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. T'o 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 levice an be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA mey 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 requirements on the Acconnents 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

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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 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™ IGA Flex® reagent cartridge

Indications for Use: 1-061338

Dimension Vista™ IGA Flex® reagent cartridge:

The IgA method is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin A in human serum and heparinized plasma on the Dimension Vista™ System. Measurements of IgA aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

## Dimension Vista™ Protein 1 Calibrator:

PROT1 CAL is an in vitro diagnostic product for the calibration of Immunoglobulin A (IGA) and Immunoglobulin G (IGG) methods on the Dimension Vista™ System.

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

For use as an assayed intralaboratory quality control for assessment of precision and analytical bias in the determination of Immunoglobulin A (IGA) and Immunoglobulin G (IGG) on the Dimension Vista™ System.

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)

Inara Chan
Motion Sign Off

**vision Sign-Off**

Thee of In Vitra Diagnostic evice Evaluation and a afety

**510(k)** K061338

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