DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM

K081249 · Dade Behring, Inc. · DEB · Jul 21, 2008 · Immunology

Device Facts

• Record ID: K081249
• Device Name: DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM
• Applicant: Dade Behring, Inc.
• Product Code: DEB · Immunology
• Decision Date: Jul 21, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5620
• Device Class: Class 2

Intended Use

The A2MAC method is an in vitro diagnostic test for the quantitative measurement of a2-macroglobulin in human serum and plasma on the Dimension Vista® Systems. Measurements of a2-macroglobulin aid in the diagnosis of blood clotting or blood lysis disorders.

Device Story

The Dimension Vista® A2MAC Flex® reagent cartridge is an in vitro diagnostic test used on the Dimension Vista® System. It measures a2-macroglobulin concentration in human serum and plasma samples. The device operates via an immunochemical reaction where proteins in the sample form immune complexes with specific antibodies; these complexes scatter a beam of light. The intensity of the scattered light is proportional to the protein concentration, which is determined by comparison with a known standard. The system is intended for use by laboratory professionals in clinical settings. Results assist clinicians in diagnosing blood clotting or blood lysis disorders. The system also includes multi-analyte liquid human serum-based calibrators and controls (low, mid, and high levels) to ensure analytical precision and bias assessment.

Clinical Evidence

No clinical data. Bench testing only. Method comparison study (n=143) against predicate showed high correlation (r=0.993). Precision (within-lab CV 2.4-3.0%), linearity (27-640 mg/dL), and interference testing (recovery 97-110%) met acceptance criteria.

Technological Characteristics

Nephelometric assay; liquid ready-to-use reagent kit; Arsenazo-III dye; rabbit polyclonal antiserum; plastic cartridge with 12 segregated wells; buffers and polyethylene glycol; traceable to ERM-DA470 (CRM470).

Indications for Use

Indicated for quantitative measurement of alpha2-macroglobulin in human serum, heparinized plasma, and EDTA plasma to aid in diagnosis of blood clotting or blood lysis disorders.

Regulatory Classification

Identification

An alpha-2-macroglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-2-macroglobulin (a serum protein) in plasma. Measurement of alpha-2-macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.

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 § 866.9.

Predicate Devices

• N Antiserum to Human alpha 2 Macroglobulin (k053073)
• N Protein Standard SL (k860894)
• N/T Protein Controls SL L, M, and H (k012470, k012468)

Submission Summary (Full Text)

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K0812'19

JUL 2 1 2008

510(k) Summary for

Dimension Vista® A2MAC Flex® reagent cartridge

Dimension Vista® Protein 1 Calibrator

Dimension Vista® Protein 1 Control L,M,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: K081249

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: Siemens Healthcare Diagnostics. 500 GBC Drive, M/S 514 Newark, Delaware 19702 Attn: Anna Marie Kathleen Ennis Tel: [phone] Fax: [phone] Preparation date: April 28, 2008

#### 2. Device Name:

# Dimension Vista® A2MAC Flex® reagent cartridge

Dimension Vista® PROT 1 CAL

#### Dimension Vista® PROT 1 CON, L.M.H

Classification: Class II; Class II; Class I Product Code: DEB, JIX, JJY

Panel: Immunology (82) and Clinical Chemistry (75)

## 3. Identification of the Legally Marketed Devices:

Dade Behring N Antisera to Human a2- macroglobulin - K053073

N Protein Standard SL - K012470

N/T Protein Controls SL - K012468

#### 4. Device Descriptions:

#### Dimension Vista® A2MAC 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

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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; ar-acid glycoprotein, a1 -antitrypsin, a2 -macroglobulin, b2 -microglobulin, C3 complement, C4 complement,ceruloplasmin, haptoglobin, hemopexin, immunoglobulin A, immunoglobulin E,, immunoglobulin G, immunoglobulin G Subclass , immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin M, prealbumin, retinol binding protein, homocysteine, soluble transferrin receptor and transferrin.

## Dimension Vista® Protein 1 Control L

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

a1-acid glycoprotein, a1-antitrypsin, a2 -macroglobulin, C3 complement, C4 complement,ceruloplasmin, haptoglobin, hemopexin,immunoglobulin E, immunoglobulin A, immunoglobulin G, immunoglobulin G Subclass , immunoglobulin G subclass 2. immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin M, prealbumin, retinol binding protein,homocysteine, soluble transferrin receptor and 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 scrum based products containing: aj -acid glycoprotein, a1 -antitrypsin, a2 -macroglobulin, b2microglobulin, C3 complement, C4 complement,ceruloplasmin, haptoglobin, hemopexin, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G Subclass . immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin M, prealbumin, retinol binding protein, homocysteine, soluble transferrin receptor, and transferrin.

# 5. Device Intended Uses

## Dimension Vista® A2MAC Flex® reagent cartridge:

The A2MAC method is an in vitro diagnostic test for the quantitative measurement of amacroglobulin in human serum and plasma on the Dimension Vista® Systems. Measurements of a2 -macroglobulin aid in the diagnosis of blood clotting or blood lysis disorders.

## Dimension Vista® PROT 1 CAL:

PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® Systems for: a1-Acid Glycoprotein (A1AG), a-Antitrypsin (A1AT), a2-macroglobulin (A2MAC), 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, IGG-C*), 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)

*For cerebrospinal fluid

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### 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® Systems in the quantitative determination of:

a1-Acid Glycoprotein (A1AG), a1-Antitrypsin (A1AT), a2-macroglobulin (A2MAC), 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), specialty Albumin (sALB*), soluble Transferrin Receptor (STFR) and Transferrin (TRF).

*For serum and plasma

# Dimension Vista® Protein 1 Control M and H

PROTI CON M and PROT1 CON H are assayed, mid-level and high level, intralaboratory quality controls for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: a2-Acid Glycoprotein (A1AG), a1 -Antitrypsin (A1AT), a]-Macroglobulin (A2MAC), 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), 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), specialty Albumin (sALB) and Transferrin (TRF).

*For serum and plasma

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

The Dimension Vista® A2MAC Flex® reagent cartridge, Dimension Vista® PROT 1 CAL and Dimension Vista® PROT 1 CON L, M, H are substantially equivalent to the Dade Behring N Antisera to Human a2 –macroglobulin assay (K053073), N/T Protein Standard SL (K012470) and N Protein Controls SL (K012468). The Dimension Vista® A2MAC assay, like Dade Behring N Antisera to Human a2-macroglobulin assay is an in vitro diagnostic test for the quantitative measurement of a2 ~macroglobulin in human serum and plasma.

# 7. Device Performance Characteristics:

The Dimension Vista® A2MAC assay was compared to the Dade Behring N Antisera to Human a2-macroglobulin assay on the BN ProSpec® System by evaluating serum and plasma samples with concentrations ranging from 28 - 637 mg/dL. Regression analysis of these results vielded the following equation.

## Method Comparison Study

The Dimension Vista® A2MAC assay was compared to the N Antisera to Human anmacroglobulin on the BN ProSpec® System by evaluating serum and plasma samples with concentrations ranging from 28 - 637 mg/dL (0.28 - 6.37 g/L). Regression analysis of these results yielded the following equation:

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| Comparative Method | Slope | Intercept<br>mg/dL [g/L] | Correlation<br>Coefficient | n |
|-----------------------------------------------|-------|--------------------------|----------------------------|-----|
| α2-macroglobulin on the<br>BN ProSpec® System | 1.042 | +6.3 [+0.063] | 0.993 | 143 |

# 8. Conclusion:

These studies demonstrate correlation and equivalent performance between the Dade Behring N Antisera to Human a2-Macroglobulin assay and the Dimension Vista® A2MAC assay.

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Image /page/4/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 stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# JUL 2 1 2008

Siemens Healthcare Diagnostics c/o Ms. Anna Marie K. Ennis Sr. regulatory Affairs and Compliance Specialist 500 GBC Drive M/S 514 Newark, DE 19714-6101

Re: k081249

Trade/Device Name: Dimension Vista® A2MAC 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 866.5620 Regulation Name: Alpha-2-macroglobulin antigen, antiserum, control Regulatory Class: Class II

Product Code: DEB, JIX, JJY Dated: May 1, 2008

Received: May 2, 2008

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

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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 vour 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 advice for your device on our labeling regulation (21 CFR Part 801), 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 yours,

m chan

Maria M. Chan, Ph.D. Acting Division 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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510(k) Number (if known): Ko & / > 4 9

Dimension Vista® A2MAC Flex® reagent cartridge Device Name:

Indications For Use:

#### Dimension Vista® A2MAC Flex® reagent cartridge:

The A2MAC method is an in vitro diagnostic test for the quantitative measurement of a2-macroglobulin in human serum and plasma on the Dimension Vista® System. Measurements of α2-macroglobulin aid in the diagnosis of blood clotting or blood lysis disorders.

Prescription Use × (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter-Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

ve m chan
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation cu

510(k) K081249

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510(k) Number (if known): JaO8 /2 49

Dimension Vista® PROT 1 CAL Device Name:

Indications For Use:

### Dimension Vista® PROT 1 CAL:

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

a - Acid Glycoprotein (A 1AG) a1-Antitrypsin (A1AT) α2-Macroglobulin (Α2ΜΑC) B2-Microglobulin (B2MIC) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoqlobulin A (IGA) * For cerebrospinal fluid (CSF) Immunoglobulin E (IGE) Immunoglobulin G (IGG, IGG-C*) 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 X (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter-Use (21 CFR 801 Subpart C)

IPLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

Page 1 of

Marie M Chan

Office of In Vitro Diagnostic Device Evaluation and Safely

510(k) K0d1249

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510(k) Number (if known): Ko 8/2 49

Dimension Vista® PROT 1 CON L Device Name:

#### Indications For Use:

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

a1-Acid Glycoprotein (A1AG) a1-Antitrypsin (A1AT) a2-Macroglobulin (A2MAC) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoglobulin E (IGE) * For serum and plasma

× --Prescription Use (Per 21 CFR 801 Subpart D)

Retinol binding Protein (RBP) soluble Transferrin Receptor (STFR) specialty Albumin (sALB*) Transferrin (TRF)

Immunoglobulin G (IGG)

İmmunoglobulin M (IGM) Prealbumin (PREALB)

Immunoglobulin G Subclass 1 (IGG1) Immunoglobulin G Subclass 2 (IGG2)

Immunoglobulin G Subclass 3 (IGG3)

Immunoglobulin G Subclass 4 (IGG4)

AND/OR Over-The-Counter-Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

Page 1 of

mchan

**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K081249

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510(k) Number (if known):

#### Dimension Vista® PROT 1 CON M Device Name:

Indications For Use:

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

| α₁-Acid Glycoprotein (A1AG) | Immunoglobulin G (IGG) |
|-----------------------------|-------------------------------------|
| α₁-Antitrypsin (A1AT) | Immunoglobulin G Subclass 1 (IGG1) |
| α₂-Macroglobulin (A2MAC) | Immunoglobulin G Subclass 2 (IGG2) |
| β₂-Microglobulin (B2MIC) | Immunoglobulin G Subclass 3 (IGG3) |
| C3 Complement (C3) | Immunoglobulin G Subclass 4 (IGG4) |
| C4 Complement (C4) | Immunoglobulin M (IGM) |
| Ceruloplasmin (CER) | Prealbumin (PREALB) |
| Haptoglobin (HAPT) | Retinol binding Protein (RBP) |
| Hemopexin (HPX) | soluble Transferrin Receptor (STFR) |
| Homocysteine (HCYS) | specialty Albumin (sALB*) |
| Immunoglobulin A (IGA) | Transferrin (TRF) |
| Immunoglobulin E (IGE) | |

For serum and plasma

Prescription Use × (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter-Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

Page 1 of

Maria M Chan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Saft

510(k) K081249

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510(k) Number (if known):

#### Dimension Vista® PROT 1 CON H Device Name:

Indications For Use:

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

| a₁-Acid Glycoprotein (A1AG) | Immunoglobulin G (IGG) |
|-----------------------------|-------------------------------------|
| a₁-Antitrypsin (A1AT) | Immunoglobulin G Subclass 1 (IGG1) |
| a₂-Macroglobulin (A2MAC) | Immunoglobulin G Subclass 2 (IGG2) |
| B₂-Microglobulin (B2MIC) | Immunoglobulin G Subclass 3 (IGG3) |
| C3 Complement (C3) | Immunoglobulin G Subclass 4 (IGG4) |
| C4 Complement (C4) | Immunoglobulin M (IGM) |
| Ceruloplasmin (CER) | Prealbumin (PREALB) |
| Haptoglobin (HAPT) | Retinol binding Protein (RBP) |
| Hemopexin (HPX) | soluble Transferrin Receptor (STFR) |
| Homocysteine (HCYS) | specialty Albumin (sALB*) |
| Immunoglobulin A (IGA) | Transferrin (TRF) |
| Immunoglobulin E (IGE) | |

* For serum and plasma

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter-Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

Page 1 of

·

Maria McHan
Division Sign-Off

**Division Sign-Off**

Office of In Vitro Diagnostic
Device Evaluation and Safety

510(k) K081249