DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH

K063272 · Dade Behring, Inc. · JZG · Jan 26, 2007 · Immunology

Device Facts

• Record ID: K063272
• Device Name: DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH
• Applicant: Dade Behring, Inc.
• Product Code: JZG · Immunology
• Decision Date: Jan 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5630
• Device Class: Class 2

Intended Use

Dimension Vista™ B2MIC Flex® reagent cartridge: The B2MIC method is an in vitro diagnostic test for the quantitative determination of β2-microglobulin in human serum, or heparinized or EDTA plasma on the Dimension Vista® System. Measurements of ß2-microglobulin aid in the diagnosis of renal dysfunction. Dimension Vista™ Protein 1 Calibrator: PROT1 CAL is an in vitro diagnostic product for the calibration of the ßmicroglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), lmmunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin / Transthyretin (PREALB) methods on the Dimension Vista® System. Dimension Vista™ Protein 1 Control M and H: PROT1 CON M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of ß2microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin / transthyretin (PREALB) on the Dimension Vista® System.

Device Story

Device uses immunonephelometry to quantify human β2-Microglobulin in serum or plasma samples. Input: patient serum/plasma sample mixed with polystyrene particles coated with mouse monoclonal anti-β2-Microglobulin antibodies. Principle: antibody-coated particles aggregate upon binding to β2-Microglobulin; light scattering intensity is measured, which is proportional to protein concentration. Output: quantitative β2-Microglobulin concentration. Used in clinical laboratory settings on the Dimension Vista® System; operated by laboratory technicians. Results aid clinicians in diagnosing renal dysfunction. System includes reagent cartridges, multi-analyte calibrators, and quality controls.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2 (intra-assay CV 1.97-3.01%; inter-assay CV 2.94-4.08%). Linearity confirmed 0.66–37.42 mg/L. Interference testing per CLSI EP7-A2 showed no significant interference from common substances. Method comparison (n=143) against predicate showed high correlation (r=0.998, slope 0.942). No clinical data required.

Technological Characteristics

Immunoturbidimetric assay using polystyrene particles coated with anti-human β2-microglobulin antibodies. Measures light scatter intensity proportional to protein concentration. System-based automated analysis. Reagents include liquid human serum-based calibrators and controls.

Indications for Use

Indicated for quantitative determination of β2-microglobulin in human serum, heparinized plasma, or EDTA plasma to aid in the diagnosis of renal dysfunction.

Regulatory Classification

Identification

A beta-2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques beta-2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement of beta-2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.

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 Latex β₂-Microglobulin assay (k002731)
• Dade Behring N Protein Standard SL (k012470)
• Dade Behring N/T Protein Controls SL (k012468)

Submission Summary (Full Text)

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# 510(k) Summary for Dimension Vista" B2MIC Flex® reagent cartridge
Dimension Vista™ Protein 1 Control M and H

JAN 2 6 7007

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: K063272

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

| Manufacturer: | Dade Behring Marburg GmbH |
|---------------|---------------------------|
| | Emil-von-Behring Str. 76 |
| | 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: October 27, 2006
- Dimension Vista" B2MJC Flex® reagent cartridge
Dimension Vista" Protein 1 Calibrator
Dimension Vista" Protein 1 Control M
Dimension Vista" Protein 1 Control M 2. Device Name:

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

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

Dade Behring N Latex β2-Microglobulin - K002731 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468

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Dade Behring Inçi Dimension Vista B2MIC 510(k) Notification

#### 4. Device Description:

## Dimension Vista™ B2MIC Flex® reagent cartridge

Polystyrene particles coated with specific antibodies to human β2-microglobulin are aggregated when mixed with samples containing human ß2-microglobulin. These aggregates 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 β2microalobulin C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), and prealbumin / transthyretin (PREALB).

## Dimension Vista" Protein 1 Control M and H

Protein 1 Control M and H are multi-analyte, liquid, human serum based products containing ß2-microglobulin C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), and prealbumin / transthyretin (PREALB).

#### 5. Device Intended Use:

## Dimension Vista " B2MIC Flex® reagent cartridge:

Dintenofon Tiota - Danno Piox - loagnostic test for the quantitative determination of ß2microglobulin in human serum, or heparinized or EDTA plasma on the Dimension Vista System. Measuresments of ß2-microglobulin aid in the diagnosis of renal dysfunction.

## Dimension Vista™ Protein 1 Calibrator:

PROT1 CAL is an in vitro diagnostic product for the calibration of the ß2-microglobulin (B2MIC), C3 complement (C3), C4 complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin / Transthyretin (PREALB) methods on the Dimension Vista® System.

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

PROT1 CON M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of β2-microglobulin (Β2ΜΙΟ), C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin / transthyretin (PREALB) on the Dimension Vista® System.

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

The Dimension Vista" B2MC Flex® reagent cartridge, Dimension Vista " Protein 1 Calibrator
and Dimension Vista" Protein 1 Control M and H are substantially equivalent to the D Behring N Latex (32-Microglobulin assay (K002731), N Protein Standard SL (K012470), and N/T Protein Control SL (K012468), respectively.

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#### Device Performance Characteristics: 7.

The Dimension Vista" B2MlC assay was compared to the Dade Behring N Latex β>
Microglobulin assay on the BN ProSpec" System by evaluating serum and plaaksin Microgiobalin assay on the Bronney from 0.81 to 21.94 mg/L. Regression analysis of these results yielded the following equation:

### Method Comparison Study

| Comparative Method | n | Slope | Intercept | Correlation Coefficient |
|---------------------------------------------------|-----|-------|-----------|-------------------------|
| N Latex β₂-Microglobulin<br>on BN ProSpec® System | 143 | 0.942 | -0.029 | 0.998 |

#### 8. Conclusion:

These studies demonstrate correlation and equivalent performançe between the Dade
Behring N Latex β--Microglobulin assay and the Dimension Vista " B2MIC assay.

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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 depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The bird is facing to the right. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

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

JAN 26 2007

# Re: k063272

Trade/Device Name: Dimension Vista™ B2MIC Flex® reagent cartridge Dimension Vista™ Protein 1 Calibrator Dimension Vista™ Protein 1 Control M Dimension Vista™ Protein 1 Control H Regulation Number: 21 CFR 866.5630 Regulation Name: Beta-2-Microglobulin Immunological Test System Regulatory Class: Class II Product Code: JZG, JIX, JJY Dated: December 20, 2006 Received: December 26, 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

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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" (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.

Ret. J. Keating, Jr.

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

K063272

Device Name:

Dimension Vista" B2MIC Flex® reagent cartridge
Dimension Vista" Protein 1 Calibrator Dimension Vista" Protein 1 Control M
Dimension Vista" Protein 1 Control M
Dimension Vista" Protein 1 Control H

# Indications for Use:

# Dimension Vista™ B2MIC Flex® reagent cartridge:

The B2MIC method is an in vitro diagnostic test for the quantitative determination of β2-microglobulin in human serum, or heparinized or EDTA plasma on the Dimension Vista® System. Measurements of ß2-microglobulin aid in the diagnosis of renal dysfunction.

# Dimension Vista™ Protein 1 Calibrator

PROT1 CAL is an in vitro diagnostic product for the calibration of the ßmicroglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), lmmunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin / Transthyretin (PREALB) methods on the Dimension Vista® System.

# Dimension Vista™ Protein 1 Control M and H

PROT1 CON M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of ß2microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin / transthyretin (PREALB) on the Dimension Vista® System.

Prescription Use X (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)

mana m cham

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063272

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