DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H

K072435 · Dade Behring, Inc. · JIX · Oct 17, 2007 · Clinical Chemistry

Device Facts

• Record ID: K072435
• Device Name: DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H
• Applicant: Dade Behring, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Oct 17, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

PROT3 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for the a1 -Microglobulin (A1MIC), Cystatin C(CYSC), Microalbumin (MALB) and specialty Albumin (sALB)* methods. * For serum, plasma and cerebrospinal fluid. PROT3 CON is an assayed intralaboratory quality control, for assessment of precision and analytical bias in the determination of a 1-Microglobulin (A IMIC), specialty Albumin (sAlb)** and Microalbumin (MALB) on the Dimension Vista System. ** For cerebrospinal fluid (CSF). PROT1 CON L is an assayed, low level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista System in the quantitative determination of: a1-Acid Glycoprotein (A1AG) a1-Antitrypsin (A1AT) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoglobulin E (IGE) Immunoglobulin G (IGG) Immunoglobulin M (IGM) Prealbumin (PREALB) soluble Transferrin Receptor (sTFR) specialty Albumin (sALB)*** Transferrin (TRF). PROT1 CON M and PROT1 CON H are assayed, mid-level and high level respectively, intralaboratory quality controls for assessment of precision and analytical bias on the Dimension Vista System in the quantitative determination of: a1-Acid Glycoprotein (A1AG) a1-Antitrypsin (A1AT) B2-Microglobulin (B2MIC) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoglobulin E (IGE) Immunoglobulin G (IGG) Immunoglobulin M (IGM) Prealbumin (PREALB) specialty Albumin (sALB)*** soluble Transferrin Receptor (sTFR) Transferrin (TRF). *** For serum and plasma.

Device Story

Dimension Vista® Protein Controls and Calibrator are human-derived, liquid or lyophilized products used to calibrate and monitor the performance of the Dimension Vista® System. Controls (L, M, H) assess precision and analytical bias; Calibrator (PROT3 CAL) establishes system calibration. Used in clinical laboratories by technicians; output is used by healthcare providers to verify assay accuracy and ensure reliable patient test results for protein analytes. Benefits include standardized diagnostic testing and improved clinical decision-making through validated system performance.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Multi-analyte, lyophilized or liquid formulations based on polygeline or human serum. Contains human-derived proteins. Designed for use on the Dimension Vista System. No specific materials standards or software algorithms described.

Indications for Use

Indicated for use as intralaboratory quality control and calibration material for the Dimension Vista® System to assess precision, analytical bias, and calibration for various serum, plasma, and cerebrospinal fluid protein analytes.

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 3 Calibrator (K063508)
• Dimension Vista® Protein 3 Control (K063508)
• Dimension Vista® Protein 1 Control L (K063663)
• Dimension Vista® Protein 1 Control M (K063663)
• Dimension Vista® Protein 1 Control H (K063663)

Submission Summary (Full Text)

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# Dade Behring

Every minute of every day™

0CT 1 7 2007

510(k) Summary for Dimension Vista® Protein 3 Calibrator
Dimension Vista® Protein 3 Control Dimension Vista® Protein 1 Control L Dimension Vista® Protein 1 Control M Dimension Vista® Protein 1 Control 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: KO72435

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

| | Manufacturer: | Dade Behring Inc. Marburg GmbH<br>Emil-von-Behring Str. 76<br>35041 Marburg, Germany |
|----|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Information: | Dade Behring Inc.<br>P.O. Box 6101<br>Newark, Delaware 19714-6101<br>Attn: A. Kathleen Ennis<br>Tel: [phone]<br>Fax: [phone] |
| | Preparation date: | August 27, 2007 |
| 2. | Device Name: | Dimension Vista® Protein 3 Calibrator<br>Dimension Vista® Protein 3 Control<br>Dimension Vista® Protein 1 Control L<br>Dimension Vista® Protein 1 Control M<br>Dimension Vista® Protein 1 Control H |
| | Classification:<br>Product Code:<br>Panel: | Class II; Class I<br>JIX; JJY<br>Clinical Chemistry (75) |

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

| Dimension Vista® Protein 3 Calibrator | K063508 |
|---------------------------------------|---------|
| Dimension Vista® Protein 3 Control | K063508 |
| Dimension Vista® Protein 1 Control L | K063663 |

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# DADE BEHRING

Every minute of every day"

Dimension Vista® Protein 1 Control M K063663 Dimension Vista® Protein 1 Control H K063663

## Device Descriptions:

4.

## Dimension Vista® Protein 3 Calibrator

PROT3 CAL is a multi-analyte, lyophilized, polygeline based product containing urinary a1-microglobulin, cystatin C and serum albumin of human origin.

## Dimension Vista® Protein 3 Control

PROT3 CON is a multi-analyte, low level lyophilized, polygeline and rabbit albumin based product containing urinary a1 -microglobulin and serum albumin of human origin.

## Dimension Vista® Protein 1 Control L

Protein 1 Control L is a multi-analyte, low level liquid human serum based product containing:

- α1-acid glycoprotein αι-antitrypsin C3 complement C4 complement ceruloplasmin haptoglobin homocysteine immunoglobulin A
immunoglobulin E immunoglobulin G immunoglobulin M prealbumin soluble transferrin receptor albumin transferrin

## Dimension Vista® Protein 1 Control M and Dimension Vista® Protein 1 Control H

Protein I Control M and H are multi-analyte, mid and high level respectively, liquid human serum based products containing:

| α₁-acid glycoprotein | immunoglobulin A |
|----------------------|------------------------------|
| α₁-antitrypsin | immunoglobulin E |
| ß₂-microglobulin | immunoglobulin G |
| C3 complement | immunoglobulin M |
| C4 complement | prealbumin |
| ceruloplasmin | soluble transferrin receptor |
| haptoglobin | albumin |
| homocysteine | transferrin |

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## 5. Device Intended Uses:

## Dimension Vista® Protein 3 Calibrator

PROT3 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for the a1 -Microglobulin (A1MIC), Cystatin C(CYSC), Microalbumin (MALB) and specialty Albumin (sALB)* methods.

* For serum, plasma and cerebrospinal fluid

## Dimension Vista® Protein 3 Control

PROT3 CON is an assayed intralaboratory quality control, for assessment of precision and analytical bias in the determination of a 1-Microglobulin (A IMIC), precision and thaty trear blas in the acted by on the Dimension (11777).
specialty Albumin (sAlb)** and Microalbumin (MALB) on the Dimension Vista " System.

** For cerebrospinal fluid (CSF)

## Dimension Vista® Protein 1 Control L

PROTI CON L is an assayed, low level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista 9 System in the quantitative determination of:

a1-Acid Glycoprotein (A1AG) a - Antitrypsin (A1AT) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Homocysteine (HCYS) Immunoglobulin A (IGA)

Immunoglobulin E (IGE) Immunoglobulin G (IGG) Immunoglobulin M (IGM) Prealbumin (PREALB) soluble Transferrin Receptor (sTFR) specialty Albumin (sALB)*** Transferrin (TRF)

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# Dade Behring

Every minute of every day"

## Dimension Vista® Protein 1 Control M and Dimension Vista® Protein 1 Control H

PROT1 CON M and PROT1 CON H are assayed, mid-level and high level respectively, intralaboratory quality controls for assessment of precision and analytical bias on the Dimension Vista System in the quantitative determination

| α₁-Acid Glycoprotein (A1AG) | Immunoglobulin A (IGA) |
|-----------------------------|-------------------------------------|
| α₁-Antitrypsin (A1AT) | Immunoglobulin E (IGE) |
| β₂-Microglobulin (B2MIC) | Immunoglobulin G (IGG) |
| C3 Complement (C3) | Immunoglobulin M (IGM) |
| C4 Complement (C4) | Prealbumin (PREALB) |
| Ceruloplasmin (CER) | specialty Albumin (sALB)*** |
| Haptoglobin (HAPT) | soluble Transferrin Receptor (STFR) |
| Homocysteine (HCYS) | Transferrin (TRF) |
| *** For serum and plasma | |

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

Dimension Vista® Protein 3 Calibrator and Dimension Vista® Protein 3 Control modified to include specialty Albumin (sALB), are substantially equivalent in intended use to the current Dimension Vista® Protein 3 Calibrator and Dimension Vista® Protein 3 Control (K063508). The modified Protein 3 Calibrator and Protein 3 Control, like the current products, are intended to be used for the calibration of human protein assays and for use as assayed intralaboratory quality controls respectively, on the Dimension® Vista System.

Dimension Vista® Protein 1 Control L, Dimension Vista® Protein 1 Control M and Dimension Vista® Protein 1 Control H modified to include specialty Albumin (sALB), are substantially equivalent in intended use to the current Dimension Vista® Protein 1 Control L, Dimension Vista® Protein 1 Control M and Dimension Vista® Protein 1 Control H (K063663). Modified Protein 1 Control L, M, and H, like the current products, are intended to be used as assaved intralaboratory quality controls on the Dimension® Vista System.

#### 7. Conclusion

The modified Dimension Vista® Protein 3 Calibrator, Dimension Vista® Protein 3 Control and Dimension Vista® Protein 1 Control L, Dimension Vista® Protein 1 Control M and Dimension Vista Protein 1 Control H, are substantially equivalent to the legally marketed devices based on the information described above.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dade Behring Inc. c\o Ms. A. Kathleen Ennis Sr. Regulatory Affairs & Compliance Spec. 500 GBC Drive, MS 514, P.O. Box 6101 Newark, DE 19714-6101

OCT 1 7 2007

k072435 Re:

> Trade Name: Dimension Vista® Protein 3 Calibrator, Dimension Vista® Protein 3 Control, Dimension Vista® Protein 3 Control L, Dimension Vista® Protein 3 Control M, Dimension Vista® Protein 3 Control H Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX, JJY Dated: August 28, 2007 Received: August 30, 2007

Dear Ms. Ennis:

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 logally 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 yours.

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

Sean 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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#### Indications Statement

### Device Name: Dimension Vista® Protein 3 Calibrator

#### Indications for Use:

### Dimension Vista® Protein 3 Calibrator

PROT3 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for the q-Microglobulin (A1MIC), Cystatin C (CYSC), Microalbumin (MALB) and specialty Albumin (sALB)* methods.

* For serum, plasma and cerebrospinal fluid

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)

Division Sign-Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

072

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#### Indications Statement

Device Name: Dimension Vista® Protein 3 Control

Indications for Use:

Dimension Vista® Protein 3 Control Intended Use

PROT3 CON is an assayed intralaboratory quality control, for assessment of precision and analytical bias in the determination of a-Microglobulin (A1MIC), specialty Albumin (SALB) and Microalbumin (MALB) on the Dimension Vista® System.

1 For cerebrospinal fluid (CSF)

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 275

Signature

**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k072435

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#### Indications Statement

### Device Name: Dimension Vista® Protein 1 Control L

#### Indications for Use:

### Dimension Vista® Protein 1 Control L

PROT1 CON L is an assayed, low level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of:

a1-Acid Glycoprotein (A1AG) a1-Antitrypsin (A1AT) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Homocysteine (HCYS) Immunoglobulin A (IGA)

Immunoglobulin E (IGE) Immunoglobulin G (IGG) Immunoglobulin M (IGM) Prealbumin (PREALB) specialty Albumin* (sALB) soluble Transferrin Receptor (STFR) Transferrin (TRF)

*For serum and plasma

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)

CLL

Page 3 of 5

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k072435

IVISION SIgn-O

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#### Indications Statement

Device Name: Dimension Vista® Protein 1 Control M

Indications for Use:

#### Dimension Vista® Protein 1 Control M

PROT1 CON M is an assayed, mid-level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista System in the quantitative determination of:

- a Acid Glycoprotein (A1AG) a 1-Antitrypsin (A1AT) B2- Microglobulin (B2MIC) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Homocysteine (HCYS)
Immunoglobulin A (IGA) Immunoglobulin E (IGE) Immunoglobulin G (IGG) Immunoglobulin M (IGM) Prealbumin (PREALB) specialty Albumin* (sALB) soluble Transferrin Receptor (STFR) Transferrin (TRF)

*For serum and plasma

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)

ivision Sign Off

Division Sign-Off

Page 4 of 5

Office of In Vitro Diagnostic Device Evaluation and Safety

5100(K) K072435

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#### Indications Statement

## Device Name: Dimension Vista® Protein 1 Control H

Indications for Use:

#### Dimension Vista® Protein 1 Control H

PROT1 CON H is an assayed, high level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista System in the quantitative determination of:

a1-Acid Glycoprotein (A1AG) a1-Antitrypsin (A1AT) B2- Microglobulin (B2MIC) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Homocysteine (HCYS)

Immunoglobulin A (IGA) Immunoglobulin E (IGE) Immunoglobulin G (IGG) Immunoglobulin M (IGM) Prealbumin (PREALB) specialty Albumin* (sALB) soluble Transferrin Receptor (STFR) Transferrin (TRF)

*For serum and plasma

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)

CfCL

Page 54/5

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Office of In Vitro Diagnostic Device Evaluation and Safety

FO(K) k072435