DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H

K071980 · Dade Behring, Inc. · JJY · Sep 11, 2007 · Clinical Chemistry

Device Facts

• Record ID: K071980
• Device Name: DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H
• Applicant: Dade Behring, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Sep 11, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

PROT1 Cal is an in vitro diagnostic product for the calibration of the Dimension Vista® System for: α₁-acid glycoprotein, α₁ antitrypsin, β₂-microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocysteine, IgA, IgE, IgG, IgG subclasses (IgG1, IgG2, IgG3, and IgG4), IgM, prealbumin, retinol binding protein, soluble transferrin receptor, and transferrin. PROT1 CON L is an assayed, low level, intra-laboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: α₁-acid glycoprotein, α₁ antitrypsin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocysteine, IgA, IgE, IgG, IgG subclasses (IgG1, IgG2, IgG3, and IgG4), IgM, prealbumin, retinol binding protein, soluble transferrin receptor, and transferrin. PROT1 CON M and H are assayed, mid- and high level, intra-laboratory quality controls for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: α₁-acid glycoprotein, α₁-antitrypsin, β₂-microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocysteine, IgA, IgE, IgG, IgG subclasses (IgG1, IgG2, IgG3, and IgG4), IgM, prealbumin, retinol binding protein, soluble transferrin receptor, and transferrin.

Device Story

Multi-analyte, liquid, human serum-based calibrator and quality control materials; used for calibration and assessment of precision/analytical bias on the Dimension Vista System; contains sodium azide preservative; provides reference values for specific proteins including hemopexin, IgG subclasses, and retinol binding protein; used by laboratory personnel in clinical settings to ensure accuracy of automated turbidimetric immunoassays.

Clinical Evidence

No clinical data. Bench testing only. Stability studies conducted over 24 months; value assignment validated against ERM-DA470 and highly purified protein preparations.

Technological Characteristics

Liquid, human serum-based multi-analyte products. Calibrator and controls are designed for use on the Dimension Vista System. No specific materials or software algorithms described for the calibrator/control products themselves.

Indications for Use

Indicated for use as calibrators and quality control materials for the quantitative determination of specific proteins on the Dade Behring Dimension Vista System. For prescription use only.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Dimension Vista® Protein 1 Calibrator and Protein 1 Control L, M, and H (k063663)

Submission Summary (Full Text)

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

SEP 1 1 2007

# 510(k) Summary for Dimension Vista® Protein 1 Calibrator and 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:

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

| Manufacturer: | Dade Behring 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: | June 8, 2007 |
| Device Name: | Dimension Vista® Protein 1 Calibrator<br>Dimension Vista® Protein 1 Control L<br>Dimension Vista® Protein 1 Control M<br>Dimension Vista® Protein 1 Control H |

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

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

2.

| Dimension Vista® Protein 1 Calibrator | K063663 |
|---------------------------------------|---------|
| Dimension Vista® Protein 1 Control L | K063663 |
| Dimension Vista® Protein 1 Control M | K063663 |
| Dimension Vista® Protein 1 Control H | K063663 |

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#### 4. Device Descriptions:

## Dimension Vista® Protein 1 Calibrator

Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing: a - acid glycoprotein immunoglobulin G a - antitrypsin immunogiobulin G Subclass 1 B »- microalobulin immunoglobulin G Subclass 2 C3 complement immunoglobulin G Subclass 3 C4 complement immunoglobulin G Subclass 4 ceruloplasmin immunoqlobulin M haptoglobin prealbumin hemopexin retinol binding protein homocysteine soluble transferrin receptor immunoglobulin A transferrin immunoglobulin E

## Dimension Vista® Protein 1 Control L

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

- a-acid glycoprotein a 1-antitrypsin C3 complement C4 complement ceruloplasmin haptoqlobin hemopexin homocysteine immunoglobulin A immunoglobulin E
immunoqlobulin G immunoglobulin G Subclass 1 immunoglobulin G Subclass 2 immunoqlobulin G Subclass 3 immunoglobulin G Subclass 4 immunoglobulin M prealbumin retinol binding protein soluble transferrin receptor transferrin

## Dimension Vista® Protein 1 Control M and H

Protein 1 Control M and H are multi-analyte, mid and high level respectively, liquid human serum based products containing :

- a1-acid glycoprotein a-antitrypsin B2-microglobulin C3 complement C4 complement ceruloplasmin haptoqlobin hemopexin homocysteine immunoglobulin A immunoglobulin E
immunoglobulin G immunoqlobulin G Subclass 1 immunoglobulin G Subclass 2 immunoglobulin G Subclass 3 immunoglobulin G Subclass 4 immunoglobulin M prealbumin retinol binding protein soluble transferrin receptor transferrin

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

#### 5. Device Intended Uses:

### Dimension Vista® Protein 1 Calibrator

PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista System for:

a - Acid Glycoprotein (A1AG) a - Antitrypsin (A1AT) B2-Microglobulin (B2MIC) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoglobulin E (IGE)

Immunoqlobulin G (IGG) Immunoglobulin G Subclass 1 (IGG1) Immunoglobulin G Subclass 2 (IGG2) Immunoqlobulin G Subclass 3 (IGG3) Immunoglobulin G Subclass 4 (IGG4) lmmunoglobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)

### 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:

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

Immunoglobulin G (IGG) Immunoqlobulin G Subclass 1 (IGG1) Immunoglobulin G Subclass 2 (IGG2) Immunoglobulin G Subclass 3 (IGG3) Immunoglobulin G Subclass 4 (IGG4) Immunoglobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)

## Dimension Vista® Protein 1 Control M and 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 of:

a1-Acid Glycoprotein (A1AG) a1-Antitrypsin (A1AT) B2-Microglobulin (B2MIC) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoglobulin E (IGE)

Immunoglobulin G (IGG) Immunoglobulin G Subclass 1 (IGG1) İmmunoglobulin G Subclass 2 (IGG2) Immunoglobulin G Subclass 3 (IGG3) Immunoglobulin G Subclass 4 (IGG4) Immunoqlobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)

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

#### 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 hemopexin (HPX), immunoglobulin G subclass 1 (IGG1), immunoglobulin G subclass 2 (IGG2), immunoqlobulin G subclass 3 (IGG3), immunoglobulin G subclass 4 (IGG4), and retinol binding protein (RBP) are substantially
equivalent in intended use to the current Dimension Vista Protein (RBP) are substantia Dimension Vista® Protein 1 Control L, M and H (K063663). The modified Dimension Vista® Protein 1 Calibrator and Protein 1 Control L, M, and H 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.

#### 7. Conclusion

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

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Image /page/4/Picture/13 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The caduceus is depicted with four curved lines that resemble wings or stylized snakes, and the text is in a sans-serif font.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dade Behring, Inc. c/o Ms AnnaMarie Kathleen Ennis Regulatory Affairs and Compliance Specialist Glasgow Site P.O. Box 6101 Newark, DE 19714-6101

SEP 1 1 2007

Re: k071980

Trade/Device Name: Dimension Vista® Protein 1 Calibrator Dimension Vista® Protein 1 Control H Dimension Vista® Protein 1 Control M Dimension Vista® Protein 1 Control L Regulation Number: 21 CFR 862.1150

Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX, JJY Dated: July 18, 2007 Received: July 18, 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 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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Page 2 -

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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours,

Robert L. Beckerf

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

Device Name: Dimension Vista Protein 1 Calibrator

Indications for Use: Ko 1990

# Dimension Vista® Protein 1 Calibrator

PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista" System for:

a1-Acid Glycoprotein (A1AG) a1-Antitrypsin (A1AT) Bo-Microglobulin (B2MIC) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoglobulin E (IGE)

Immunoglobulin G (IGG) Immunoglobulin G Subclass 1 (IGG1) Immunoglobulin G Subclass 2 (IGG2) Immunoglobulin G Subclass 3 (IGG3) Immunoglobulin G Subclass 4 (IGG4) Immunoglobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)

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)

Maria M Char

**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K07/1890

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Dade Behring Inc. Dimension Vista® Protein 1 Calibrator Dimension Vista® Protein 1 Control L, M, H 510(k) Notification

### Indications Statement

Device Name: Dimension Vista Protein 1 Control L

Indications for Use:

011980

### 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) Hemopexin (HPX) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoglobulin E (IGE)

Immunoglobulin G (IGG) Immunoglobulin G Subclass 1 (IGG1) Immunoglobulin G Subclass 2 (IGG2) Immunoglobulin G Subclass 3 (IGG3) Immunoglobulin G Subclass 4 (IGG4) Immunoglobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)

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)

Mana M Chan
Division Sign-Off

**Office of In Vitro Diagnostics**

**Device Evaluation and Safety**

51000 0 71980

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Dade Behring Inc. Dimension Vista® Protein 1 Calibrator Dimension Vista® Protein 1 Control L, M, H 510(k) Notification

### Indications Statement

Device Name: Dimension Vista® Protein 1 Control M

Indications for Use:

Image /page/8/Picture/4 description: The image contains a sequence of handwritten characters and numbers. The sequence starts with the letters 'K' and 'o', followed by the number '7'. After that, the numbers '1980' are written. The handwriting appears to be somewhat rough or stylized.

### 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:

a1-Acid Glycoprotein (A1AG) a3-Antitrypsin (A1AT) Bo-Microglobulin (B2MIC) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoglobulin E (IGE)

Immunoglobulin G (IGG) Immunoglobulin G Subclass 1 (IGG1) Immunoglobulin G Subclass 2 (IGG2) Immunoqlobulin G Subclass 3 (IGG3) Immunogiobulin G Subclass 4 (IGG4) lmmunoglobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)

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)

Maria In Chan

---

**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Ko7/980

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Dade Behring Inc. Dimension Vista® Protein 1 Calibrator Dimension Vista® Protein 1 Control L, M, H 510(k) Notification

### Indications Statement

Device Name: Dimension Vista® Protein 1 Control H

Indications for Use:

### Dimension Vista® Protein 1 Control H

PROT1 CON H is an assaved, 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) a - Antitrypsin (A1AT) B2-Microglobulin (B2MIC) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoqlobulin E (IGE)

Immunoglobulin G (IGG) Immunoglobulin G Subclass 1 (IGG1) Immunoglobulin G Subclass 2 (IGG2) Immunoglobulin G Subclass 3 (IGG3) Immunoglobulin G Subclass 4 (IGG4) Immunoglobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)

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)

Maria M Char

**Division Sign-Off**

In Vitro Dicto רות האחרא וונ

510(k) Ko71980