DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON

K072965 · Dade Behring, Inc. · DBA · Dec 21, 2007 · Immunology

Device Facts

• Record ID: K072965
• Device Name: DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON
• Applicant: Dade Behring, Inc.
• Product Code: DBA · Immunology
• Decision Date: Dec 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5250
• Device Class: Class 2

Intended Use

The C1IN method is an in vitro diagnostic test for the quantitative measurement of C1 inhibitor in human serum and plasma on the Dimension Vista Systems. Measurement of C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of angioedemia associated with lymphoma (lymph node cancer). The C1IN CAL is an in vitro diagnostic product for the calibration of the C1 inhibitor method on the Dimension Vista System. C1 inhibitor control is an assayed, mid level, intra-laboratory quality control for assessment of precision and analytical bias on the Dimension Vista System in the quantitative determination of C1 inhibitor (C1IN).

Device Story

Device is an in vitro diagnostic system for quantitative measurement of C1 inhibitor in human serum/plasma. Uses rabbit polyclonal antiserum in a reagent cartridge; operates on Dimension Vista System. Principle: immuno-nephelometry; C1 inhibitor binds with antiserum to form complexes; light scattering intensity is proportional to C1 inhibitor concentration. Instrument performs automated specimen handling, mixing, processing, and calibration. Output is a quantitative concentration value (mg/dL). Used in clinical laboratories; operated by trained laboratory personnel. Healthcare providers use results to aid diagnosis of hereditary angioneurotic edema and lymphoma-associated angioedema. Benefits include standardized, automated diagnostic testing for these conditions.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2 (CVs 2.2-5.2%). Accuracy assessed via recovery of purified C1 inhibitor (mean 98.8%). Linearity confirmed (slope 0.981, r=0.98). Interference testing per CLSI EP7-A2 showed <10% bias for tested substances. Method comparison with predicate (n=196 samples) showed strong correlation (r=0.993, slope 0.915). Matrix comparison (serum vs. heparin plasma) showed high agreement (r=0.998-1.0). No clinical sensitivity/specificity studies performed.

Technological Characteristics

Immunoturbidimetric assay; utilizes specific antibodies to form immune complexes in human serum/plasma; light scattering intensity measured to determine protein concentration. System-based diagnostic test; requires calibration and quality control materials. No specific material standards or software architecture details provided.

Indications for Use

Indicated for quantitative measurement of C1 inhibitor in human serum and plasma to aid in diagnosis of hereditary angioneurotic edema and angioedema associated with lymphoma.

Regulatory Classification

Identification

A complement C1 inhibitor (inactivator) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the complement C1 inhibitor (a plasma protein) in serum. Complement C1 inhibitor occurs normally in plasma and blocks the action of the C1 component of complement (a group of serum proteins which destroy infectious agents). Measurement of complement C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).

Predicate Devices

• N antisera to human C1 inhibitor (k960257)
• N Protein Standard PY (k960257)
• N/T Protein Control PY (k962407)

Submission Summary (Full Text)

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2.

# 510(k) Summary for Dimension Vista® C1IN Flex® reagent cartridge Dimension Vista® C1IN CAL Dimension Vista® C1IN CON

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: _______________________________________________________________________________________________________________________________________________

- 1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of 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: Kathleen Dray-Lyons<br>Tel: [phone]<br>Fax: [phone] |
| Preparation date: | October 19, 2007 |
| Device Name: | Dimension Vista ^® C1IN Flex ^® reagent cartridge<br>Dimension Vista ^® C1IN CAL<br>Dimension Vista ^® C1IN CON |

Classification: Class II; Class II; Class I Product Code: DBA; JIS; JJX Panel: Immunology (82) and Clinical Chemistry (75)

- 3. Identification of the Legally Marketed Devices:
Dade Behring N Antisera to Human C1 Inhibitor- K960257 Dade Behring N Protein Standard PY - K962410 Dade Behring N/T Protein Control PY - K962407

DEC 2 1 2007

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#### 4. Device Descriptions:

# Dimension Vista® C1IN 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 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® C1IN CAL

C1 Calibrator is a lyophilized, human plasma based product containing C1 Inhibitor (C1IN).

## Dimension Vista® C1IN CON

C1 Control is a lyophilized, mid-level, human plasma based products containing C1 Inhibitor (C1IN).

#### 5. Device Intended Uses:

# Dimension Vista® C1IN Flex® reagent cartridge:

The C1IN method is an in vitro diagnostic test for the quantitative measurement of C1 inhibitor in human serum and plasma on the Dimension Vista" System. Measurements of C1 Inhibitor aid in the diagnosis of hereditary agioneuroffic edema (increase blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).

### Dimension Vista® C1IN CAL:

The C1IN CAL is an in vitro diagnostic product for the calibration of the C1 Inhibitor (C1IN) method on the Dimension Vista® System.

### Dimension Vista® C1IN CON:

C1 Inhibitor Control 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 C1 Inhibitor (C1IN).

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

The Dimension Vista® C1N Flex® reagent cartridge, Dimension Vista® C1IN CAL and Dimension Vista® C1 CON are substantially equivalent to the Dade Behring N Antisera to Human C1 Inhibitor assay (K960257), N Protein Standard PY (K962410), and N/T Protein Control PY (K962407), respectively. The Dimension Vista® C1IN assay, like Dade Behring N Antisera to Human C1 Inhibitor is an in vitro diagnostic test for the quantitative measurement of C1 Inhibitor in human serum and plasma.

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#### Device Performance Characteristics: 7.

The Dimension Vista® C1IN assay was compared to the Dade Behring N Antisera to Human C1 Inhibitor assay on the BN ProSpec® System by evaluating serum and plasma
samples with concentrations ranging from 0.03 to 0.39 g/L. Regression analysis of these results yielded the following equation.

| Comparative Method | n | Slope | Intercept g/L | Correlation Coefficient |
|-----------------------------------------------------------|-----|-------|---------------|-------------------------|
| N Antisera to<br>C1Inhibitor on the BN<br>ProSpec® System | 196 | 0.915 | 0.006 | 0.993 |

### Method Comparison Study

#### 8. Conclusion:

These studies demonstrate correlation and equivalent performance between the Dade Behring N Antisera to Human C1 Inhibitor assay and the Dimension Vista® C1IN assay

# 000091

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure. The bird is composed of three curved lines that suggest wings and a head.

Public Health Service

DEC 2 1 2007

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k072965

Trade/Device Name: Dimension Vista C1IN Flex reagent cartridge Dimension Vista C1IN CAL Dimension Vista C1IN CON Regulation Number: 21 CFR 866.5250 Regulation Name: Complement C1 inhibitor (inactivator) immunological test system

Regulatory Class: Class II Product Code: DBA, JIT, JJX Dated: October 19, 2007 Received: October 29, 2007

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 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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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 yours,

Robert M. Becker, f

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 for Use

510(k) Number (if known): Ko 729 6J

### Device Name:

Dimension Vista® C1IN Flex® reagent cartridge Dimension Vista® C1IN CAL Dimension Vista® C1IN CON

Indications For Use:

# Dimension Vista® C1IN Flex® reagent cartridge:

The C1IN method is an in vitro diagnostic test for the quantitative measurement of C1 inhibitor in human serum and plasma on the Dimension Vista® System. Measurements of C1 Inhibitor aid in the diagnosis of hereditary angioneurotic edema (increase blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).

## Dimension Vista® C1IN CAL:

The C1IN CAL is an in vitro diagnostic product for the calibration of the C1 Inhibitor (C1IN) method on the Dimension Vista® System.

### Dimension Vista® C1IN CON:

C1 Inhibitor Control 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 C1 Inhibitor (C1IN).

AND/OR

Prescription Use × (Per 21 CFR 801 Subpart D) 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

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Maria M Chan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

5101k) Ko72965