DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H

K063322 · Dade Behring, Inc. · DDG · Jan 24, 2007 · Immunology

Device Facts

• Record ID: K063322
• Device Name: DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H
• Applicant: Dade Behring, Inc.
• Product Code: DDG · Immunology
• Decision Date: Jan 24, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5880
• Device Class: Class 2

Intended Use

Transferrin Flex® reagent cartridge: The TRF method is an in vitro diagnostic test for the quantitative determination of transferrin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista™ System. Measurements of transferrin aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia. Protein 1 Calibrator: PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 complement (C3), C4 complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), Prealbumin (PREALB) and Transferrin (TRF) methods on the Dimension Vista™ System. Protein 1 Controls L, M and H: PROT 1 CON L, M, and H are assayed intra-laboratory quality controls for assessment of precision and analytical bias in the determination of C3 complement (C3), C4 complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), Prealbumin (PREALB) and Transferrin (TRF) methods on the Dimension Vista™ System.

Device Story

Dimension Vista™ Transferrin Flex® reagent cartridge uses immunonephelometry to quantify transferrin in human serum or plasma samples. Input: patient sample mixed with rabbit polyclonal antiserum to human transferrin; immune complexes form, scattering light. Output: intensity of scattered light, proportional to transferrin concentration. Used in clinical laboratory settings on Dimension Vista™ System; operated by laboratory technicians. Results assist clinicians in diagnosing malnutrition, inflammation, infection, and iron deficiency anemia. System includes liquid, ready-to-use Protein 1 Calibrator and Protein 1 Controls (L, M, H) for calibration and quality control assessment of precision and bias.

Clinical Evidence

No clinical studies provided. Bench testing only. Precision testing (CLSI EP5-A2) showed repeatability <3.3% and within-lab imprecision <3.5%. Linearity confirmed (0.28-6.95 g/L, r=0.999). Method comparison against predicate (n=180) yielded slope 1.087, r=0.992. Interference testing showed minimal bias (<8-10%) for common endogenous/exogenous substances. Matrix comparison (serum vs. plasma) showed no significant bias.

Technological Characteristics

Immunonephelometric assay using rabbit polyclonal antiserum. Liquid, ready-to-use reagent cartridge. Measuring range 0.35 to 5.6 g/L. Traceable to ERM-DA470. Requires Dimension Vista™ System. Standards referenced: CLSI EP5-A2 (precision), EP9-A2 (method comparison), EP7-A2 (interference).

Indications for Use

Indicated for quantitative determination of transferrin in human serum, heparinized plasma, or EDTA plasma to aid in diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia. Used on the Dimension Vista System.

Regulatory Classification

Identification

A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

Predicate Devices

• Dade Behring N Antisera to Human Transferrin assay (k053075)
• N Protein Standard SL (k012470)
• N/T Protein Control SL (k012468)

Submission Summary (Full Text)

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## JAN 2 4 2007

# 510(k) Summary for Dimension Vista" TRF Flex® reagent cartridge
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: 10(13322

- 1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of 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 20, 2006

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

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

Dade Behring N Antisera to Human Transferrin- K053075 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468

Image /page/0/Picture/12 description: The image contains the word "CONFIDENTIAL" in all capital letters. The text is written in a simple, sans-serif font. The letters are evenly spaced and the word is centered in the image.

Corner 1

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#### Device Description: 4.

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

### 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, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), prealbumin (PREALB) and transferrin.

#### 5. Device Intended Use:

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

The TRF method is an in vitro diagnostic test for the quantitative determination of transferrin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista System. Measurements of transferrin aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia.

### Dimension Vista™ Protein 1 Calibrator:

PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 complement (C3), C4 complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), Prealbumin (PREALB) and Transferrin (TRF) 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), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), prealbumin (PREALB) and transferrin (TRF) on the Dimension Vista "System.

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

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

CONFIDENTIAL

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#### Device Performance Characteristics: 7.

The Dimension Vista" TRF assay was compared to the Dade Behring N Antisera to Human
Transferrin assay on the BN ProSpec" System and plasma samples vielded the Transferrin assay on the BN ProSpec "System by evaluating of these results yielded the following equation:

### Method Comparison Study

| Comparative Method | n | Slope | Intercept | Correlation<br>Coefficient |
|-------------------------------------------------------|-----|-------|-----------|----------------------------|
| N Antisera to Human Transferrin<br>on the BN ProSpec® | 180 | 1.087 | 0.060 | 0.992 |

#### Conclusion: 8.

These studies demonstrate correlation and equivalent performance between the Dade These studies demonstrate conelation and equivalent portomanse on the provincies of the assay.
Behring N Antisera to Human Transferrin assay and the Dimension Vista "TRF assa

CONFIDENTIAL

00012

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus.

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 2 4 2007

Re: k063322

Trade/Device Name: Dimension Vista™ TRF 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 866.5880 Regulation Name: Transferrin Immunological Test System Regulatory Class: Class II Product Code: DDG, 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

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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 as set forth in the quality systems (OS) 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,

Robert A. Bocteel

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

510(k) number: K063322

Dimension Vista™ TRF Flex® reagent cartridge Device Name: Dimension Vista - TRF Flex® reagent of
Dimension Vista - Protein 1 Calibration 1 Calibrary
Dimension Vista - Protein 1 Colibrol L
Dimension Vista - Protein 1 Control L
Dimens " 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™ TRF Flex® reagent cartridge:

The TRF method is an in vitro diagnostic test for the quantitative determination of transferrin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of transferrin aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia.

## Dimension Vista " Protein 1 Calibrator

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

Prescription Use × (Per 21 CFR 801 Subpart D)

Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801)

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