DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN

K063508 · Dade Behring, Inc. · JIX · Jan 23, 2007 · Clinical Chemistry

Device Facts

• Record ID: K063508
• Device Name: DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN
• Applicant: Dade Behring, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Jan 23, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Dimension Vista™ Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the α1-acid glycoprotein (A1AG), C3 complement (C3), C4 complement (C4), haptoglobin (HAPT), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin (PREALB) methods on the Dimension Vista® System. The Dimension Vista™ Protein 1 Control L, M, and H are for use as assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of α1-acid glycoprotein (A1AG), C3 complement (C3), C4 complement (C4), haptoglobin (HAPT), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin (PREALB) methods on the Dimension Vista® System. The Dimension Vista™ Protein 2 Calibrator is an in vitro diagnostic product for the calibration of the antistreptolysin O (ASL), C-reactive protein (CRP), CardioPhase® high sensitivity CRP (hsCRP) and Rheumatoid Factors (RF) methods on the Dimension Vista® System. The Dimension Vista™ Protein 2 Control L and H are for use as assayed intralaboratory quality controls for the assessment of precision and analytical bias in the determination of antistreptolysin O (ASL), C-reactive protein (CRP) and Rheumatoid Factor (RF) on the Dimension Vista® System. The Dimension Vista™ Protein 3 Calibrator is an in vitro diagnostic product for the calibration of the α1-microglobulin (A1MIC) and microalbumin (MALB) methods on the Dimension Vista® System. The Dimension Vista™ Protein 3 Control is for use as assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of α1-microglobulin (A1MIC) and microalbumin (MALB) on the Dimension Vista® System.

Device Story

Dimension Vista™ Protein 1, 2, and 3 Calibrators and Controls are liquid or lyophilized human serum/urine-based products used to calibrate and monitor the performance of specific protein assays on the Dade Behring Dimension Vista® System. Calibrators establish the relationship between instrument signal and analyte concentration; controls serve as independent samples to verify assay precision and bias. These products are used in clinical laboratory settings by trained laboratory personnel. The healthcare provider uses the resulting quality control data to validate the accuracy of patient test results before reporting. The benefit is ensuring the reliability and consistency of diagnostic protein measurements, which supports accurate clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only. Stability studies conducted over 24 months at +2 to +8°C, including stress testing at +37°C and open-vial stability. Value assignment performed using reference curves across multiple runs, vials, and replicates on nephelometric instruments.

Technological Characteristics

Multi-analyte products; Protein 1/2 are liquid human serum-based; Protein 3 is lyophilized polygeline-based with human source proteins. Designed for use on the Dimension Vista System. No specific materials or software algorithms described for the calibrators/controls themselves.

Indications for Use

Indicated for use as in vitro diagnostic calibrators and assayed intralaboratory quality controls for the Dimension Vista® System to assess precision and analytical bias for specific protein analytes (A1AG, C3, C4, HAPT, IGA, IGG, IGM, PREALB, ASL, CRP, hsCRP, RF, A1MIC, MALB).

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

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 § 862.9.

Predicate Devices

• Dimension Vista™ Protein 1 Calibrator (k062055)
• Dimension Vista™ Protein 1 Control L, M, H (k062055)
• Dimension Vista™ Protein 2 Calibrator (k062035)
• Dimension Vista™ Protein 2 Control L, H (k062035)
• Dimension Vista™ Protein 3 Calibrator (k061990)
• Dimension Vista™ Protein 3 Control (k061990)

Submission Summary (Full Text)

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Dade Behring Inc. Dado Denning me:
Dimension Vista™ Protein 1 Calibrator and Control,
Dimension Vista™ Protein 2 Calibrator and Control, and Dimension Vista™ Protein 3 Calibrator and Control 510{k} Notification

## 510(k) Summary for Dimension Vista™ Protein 1 Calibrator and Control L, M and H, Dimension Vista™ Protein 2 Calibrator and Control L and H, Dimension Vista™ Protein 3 Calibrator and Control

- 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.
JAN 2 3 2007

ith the requirements of SMDA 1990 and 21 CFR Part 807.

The assigned 510(k) number is: K063508

- Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. 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: Helen Lee Tel: [phone] Fax: [phone]

Preparation date: November 17, 2006

- Dimension Vista™ Protein 1 Calibrator 2. Device Name: Dimension Vista™ Protein 1 Control L, M, H Dimension Vista™ Protein 2 Calibrator Dimension Vista™ Protein 2 Control L and H Dimension Vista™ Protein 3 Calibrator Dimension Vista™ Protein 3 Control
Classification: Class II; Class I Product Code: JIX; JJY Panel: Clinical Chemistry (75)

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

Dimension Vista ™ Protein 1 Calibrator - K062055 Dimension Vista™ Protein 1 Control L, M, H - K062055

Dimension Vista™ Protein 2 Calibrator - K062035 Dimension Vista™ Protein 2 Control L. H - K062035

Dimension Vista™ Protein 3 Calibrator - K061990 Dimension Vista™ Protein 3 Control - K061990

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Dade Behring Inc. Dimension Vista™ Protein 1 Calibrator and Control,
Dimension Vista™ Protein 2 Calibrator and Control, and Dimension Vista™ Protein 3 Calibrator and Control 510(k) Notification

#### 4. Device Descriptions:

### Dimension Vista™ Protein 1 Calibrator

Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing a1acid glycoprotein, C3 complement, C4 complement, haptoglobin, immunoglobulin A, immunoglobulin G, immunoglobulin M and prealbumin.

## 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 a1 - acid glycoprotein, C3 complement, C4 complement, haptoglobin, immunoglobulin A, immunoglobulin G, immunoglobulin M and prealbumin.

## Dimension Vista™ Protein 2 Calibrator

Protein 2 Calibrator is a multi-analyte, liquid human serum based product containing antistreptolysin O, C-reactive protein, CardioPhase® high sensitivity CRP and rheumatoid factors.

### Dimension Vista™ Protein 2 Control L and H

Protein 2 Control L and H are multi-analyte, liquid human serum based products containing antistreptolysin O, C-reactive protein, and rheumatoid factors.

### Dimension Vista™ Protein 3 Calibrator

Protein 3 Calibrator is a multi-analyte, lyophilized, polygeline based product, with human source urinary and serum proteins, containing a - microglobulin and microalbumin.

### Dimension Vista™ Protein 3Control

Protein 3 Control is a multi-analyte, lyophilized, polygeline, rabbit based albumin product, with human source urinary and serum proteins, containing a-microglobulin and microalbumin.

#### 5. Device Intended Uses:

#### Dimension Vista™ Protein 1 Calibrator

Protein Calibrator is an in vitro diagnostic product for the calibration of the a1- acid glycoprotein (A1AG), C3 complement (C3), C4 complement (C4), haptoglobin (HAPT), 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

Protein 1 Control L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of a1- acid glycoprotein (A1AG), C3 complement (C3), C4 complement (C4), haptoglobin (HAPT), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) on the Dimension Vista® System.

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Dade Behring Inc. Dimension Vista™ Protein 1 Calibrator and Control, Dimension Vista™ Protein 2 Calibrator and Control, and Dimension Vista™ Protein 3 Calibrator and Control 510(k) Notification

### Dimension Vista™ Protein 2 Calibrator

Protein 2 Calibrator is an in vitro diagnostic product for the calibration of the antistreptolysin O (ASL), C-reactive protein (CRP), CardioPhase® high sensitivity CRP (hsCRP) and rheumatoid factors (RF) methods on the Dimension Vista® System.

### Dimension Vista™ Protein 2 Control L and H

Protein 2 Control L and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of antistreptolysin O (ASL), C-reactive protein (CRP) and rheumatoid factors (RF) on the Dimension Vista® System.

## Dimension Vista™ Protein 3 Calibrator

Protein 3 Calibrator is an in vitro diagnostic product for the calibration of the amicroglobulin (A1MIC) and microalbumin (MALB) methods on the Dimension Vista® System.

## Dimension Vista™ Protein 3Control

Protein 3 Control is an assayed intralaboratory quality control for assessment of precision and analytical bias in determination of a1-microglobulin (A1MIC) and microalbumin (MALB) on the Dimension Vista® System.

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

The Dimension Vista™ Protein 1 Calibrator and Dimension Vista™ Protein 1 Control L, M and H (modified to include 1- acid glycoprotein and haptoglobin) are substantially equivalent in intended use to the Dimension Vista™ Protein 1 Calibrator and Dimension Vista™ Protein 1 Control L, M and H (K062055).

The Dimension Vista™ Protein 2 Calibrator and Dimension Vista™ Protein 2 Control L and H (modified to include antistreptolysin O) are substantially equivalent in intended use to the Dimension Vista™ Protein 2 Calibrator and Dimension Vista™ Protein 2 Control L and H (K062035).

The Dimension Vista™ Protein 3 Calibrator and Dimension Vista™ Protein 3 Control (modified to include a - microglobulin) are substantially equivalent in intended use to the Dimension Vista™ Protein 2 Calibrator and Dimension Vista™ Protein 2 Control L and H (K061990).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Helen M. Lee. Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, DE 19714

Re:

JAN 2 3 2007

k063508 Trade/Device Name: Dimension Vista™ Protein 1 Calibrator, Dimension Vista™ Protein 1 Control L, M, H, Dimension Vista™ Protein 2 Calibrator, Dimension Vista™ Protein 2 Control L and H, Dimension Vista™ 3 Calibrator, Dimension Vista™ Protein 3 Control Regulation Number: 21 CFR § 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX, JJY Dated: November 17, 2006 Received: November 20, 2006

Dear Ms. Lee:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Dade Behring Inc. Dimension Vista™ Protein 1 Calibrator and Control, Dimension Vista™ Protein 2 Calibrator and Control. and Dimension Vista ™ Protein 3 Calibrator and Control S10(k) Notification

K06 3508

# Indications Statement

Dimension Vista™ Protein 1 Calibrator Device Name: Dimension Vista™ Protein 1 Control L Dimension Vista™ Protein 1 Control M Dimension Vista™ Protein 1 Control H

Indications for Use:

## Dimension Vista™ Protein 1 Calibrator

Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the a1acid glycoprotein (A1AG), C3 complement (C3), C4 complement (C4), haptoglobin (HAPT), 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

Protein 1 Control L. M and H are for use as assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of a 1- acid glycoprotein (A1AG), C3 complement (C3), C4 complement (C4), haptoglobin (HAPT), 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)

DIVISION S

Office of In Vitro Diagnostic Device
Evaluation and Safety

5100(A) k063508

Page 1 of 3

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# Indications Statement

## Dimension Vista™ Protein 2 Calibrator Device Name: Dimension Vista™ Protein 2 Control L Dimension Vista™ Protein 2 Control H

## Indications for Use:

## Dimension Vista™ Protein 2 Calibrator

Protein 2 Calibrator is an in vitro diagnostic product for the calibration of the antistreptolysin O (ASL), C-reactive protein (CRP), CardioPhase® high sensitivity CRP (hsCRP), and rheumatoid factors (RF) methods on the Dimension Vista® System.

## Dimension Vista™ Protein 2 Control L and H

Protein 1 Control L and H are for use as assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of antistreptolysin O (ASL). C-reactive protein (CRP), and rheumatoid factors (RF) 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) Page 2 of 3

Office of In Vitro Dinquestic Device Fivaluation and Just

K063508

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Dade Behring Inc. Dimension Vista™ Protein 1 Calibrator and Control, Dimension Vista - Protein 1 Calibrator and Control, and Dimension Vista 16 Protein 3 Calibrator and Control 510(k) Notification

K063508

# Indications Statement

Device Name:

Dimension Vista™ Protein 3 Calibrator Dimension Vista™ Protein 3 Control

Indications for Use:

## Dimension Vista™ Protein 3 Calibrator

Protein 3 Calibrator is an in vitro diagnostic product for the calibration of the armicroglobulin (A1MIC) and microalbumin (MALB) methods on the Dimension Vista® System.

# Dimension Vista™ Protein 3 Control

Protein 3 Control is for use as assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of amicroglobulin (A1MIC) and microalbumin (MALB) on the Dimension Vista® System.

Prescription Use x (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) Page 3 of 3

Gf

Office of In Vitro Diagnostic Device

K06350Y