DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH

K062055 · Dade Behring, Inc. · JIX · Aug 7, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062055
• Device Name: DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH
• Applicant: Dade Behring, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Aug 7, 2006
• 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 Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Prealbumin/Transthyretin (PREALB) methods on the Dimension Vista™ System. The Dimension Vista™ Protein 1 Control L, M, and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Prealbumin/Transthyretin (PREALB) methods on the Dimension Vista™ System.

Device Story

Dimension Vista™ Protein 1 Calibrator and Controls are liquid, human serum-based products; used for calibration and quality control of IGA, IGG, and Prealbumin assays on the Dimension Vista™ Integrated System. Calibrators establish assay traceability to ERM®-DA470 (CRM470); controls assess precision and analytical bias. Human source materials are screened for HIV-1/2, HbsAg, and HCV. Used by laboratory professionals in clinical settings to ensure accurate diagnostic testing.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Liquid, human serum-based multi-analyte products. Contains Immunoglobulin A, Immunoglobulin G, and Prealbumin. Designed for use on the Dimension Vista™ System. No specific materials of construction, energy sources, or software algorithms are described for the calibrator/control materials themselves.

Indications for Use

Indicated for use as calibrators and quality control materials for the assessment of IGA, IGG, and Prealbumin/Transthyretin levels on the Dimension Vista™ System in a clinical laboratory setting.

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 (k061338)
• Dimension Vista™ Protein 1 Control L (k061338)
• Dimension Vista™ Protein 1 Control M (k061338)
• Dimension Vista™ Protein 1 Control H (k061338)

Submission Summary (Full Text)

{0}------------------------------------------------

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

AUG - 7 2006

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.

is: K062055

The assigned 510(k) number is:

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

| Manufacturer: | Dade Behring Marburg GmbH |
|---------------|---------------------------|
| | Emil-von-Behring Str. 76 |
| | D-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: July 18, 2006

- 2. 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

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

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

Dimension Vista™ Protein 1 Calibrator - K061338 Dimension Vista™ Protein 1 Control L- K061338 Dimension Vista™ Protein 1 Control M - K061338 Dimension Vista™ Protein 1 Control H - K061338

{1}------------------------------------------------

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

#### 4. Device Description:

### Dimension Vista™ Protein 1 Calibrator

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

#### 5. Device Intended Use:

### Dimension Vista™ Protein 1 Calibrator

Protein Calibrator is an in vitro diagnostic product for the calibration of the Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Prealbumin / Transthyretin (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 Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Prealbumin / Transthyretin (PREALB) on the Dimension Vista™ Šystem.

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

The Dimension Vista™ Protein 1 Calibrator and Dimension Vista™ Protein 1 Control L, M and H (modified to include prealbumin) are substantially equivalent in intended use to the Dimension Vista™ Protein 1 Calibrator and Dimension Vista™ Protein 1 Control L, M and H (K061338).

{2}------------------------------------------------

### 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. The logo features a stylized eagle with three legs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kathleen Dray-Lyons Manager, Regulatory Affairs and Compliance Dade Behring, Inc. Glasgow Site PO Box 6101, M/S 514 Newark, DE 19714-6101

AUG - 7 2006

k062055 Re:

Trade/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 Regulation Number: 21 CFR§862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX, JJY Dated: July 18, 2006

Received: July 20, 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 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).

{3}------------------------------------------------

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,

Alberto G

Alberto Guticarez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

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

# Indications Statement

K062055

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

Indications for Use:

## Dimension Vista™ Protein 1 Calibrator

Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Prealbumin / Transthyretin (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 Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Prealbumin / Transthyretin (PREALB) 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)

Page 1 of

CA.C.V.

Division Sign-Off Division Big
Office of in Vitmo Diagnostic Device Office tion and Safety

10(k) K 062055

Image /page/4/Picture/18 description: The image shows a sequence of numbers. The numbers are 000037. The numbers are in a bold, sans-serif font.