VARELISA PR3 ANCA, MODEL NUMBER 17748/17796

K041043 · Pharmacia Deutschland GmbH · MOB · Jul 2, 2004 · Immunology

Device Facts

• Record ID: K041043
• Device Name: VARELISA PR3 ANCA, MODEL NUMBER 17748/17796
• Applicant: Pharmacia Deutschland GmbH
• Product Code: MOB · Immunology
• Decision Date: Jul 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The Varelisa PR3 ANCA EIA kit is designed for the semi-quantitative and qualitative determination of proteinase 3 anti-neutrophil cytoplasmic antibodies (PR3 ANCA) in human serum or plasma to aid in the diagnosis of Wegener's granulomatosis.

Device Story

Varelisa PR3 ANCA is an indirect noncompetitive enzyme immunoassay (EIA) for detecting PR3 ANCA in human serum or plasma. The device uses microplate strips coated with purified human PR3 antigen. Patient samples are added; PR3-specific antibodies bind to the antigen. An enzyme-labeled conjugate is added, binding to the antigen-antibody complex. A substrate is then added, which the enzyme converts into a colored solution. The rate of color formation is proportional to the concentration of PR3 antibodies in the sample. Results are classified as negative, equivocal, or positive using a set of six calibrators. The test is performed in a laboratory setting by trained personnel. Clinicians use the results as an aid in the diagnosis of Wegener's granulomatosis.

Clinical Evidence

Method comparison study performed on 270 clinically defined sera (including Wegener's granulomatosis, microscopic polyangitis, and other vasculitides). Results showed 85.1% positive agreement, 93.4% negative agreement, and 91.1% overall agreement compared to the predicate. Analytical performance included precision (within-run CV 4.8-5.9%, between-run CV 2.4-9.3%), linearity, recovery (±20%), and interference testing (no significant influence from bilirubin, hemoglobin, chyle, or RF). Cut-off established using 432 healthy donors.

Technological Characteristics

Indirect noncompetitive enzyme immunoassay (EIA). Components: microplate strips coated with human purified PR3 antigen, calibrators, positive/negative controls, enzyme-labeled conjugate, substrate, stop solution, sample diluent, wash buffer. Form factor: microplate-based. Connectivity: none (standalone).

Indications for Use

Indicated for the semi-quantitative and qualitative determination of proteinase 3 anti-neutrophil cytoplasmic antibodies (PR3 ANCA) in human serum or plasma to aid in the diagnosis of Wegener's granulomatosis. For prescription use only.

Regulatory Classification

Identification

A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

Predicate Devices

• INOVA Quanta Lite PR3 (k981328)

Submission Summary (Full Text)

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#### 510(K) SUMMARY OF SAFETY AND 9. EFFECTIVENESS

This summary of safety and effectiveness information is being submitted in accordance with the requirements of The Safety Medical Devices Act of 1990 (SMDA 1990) and 21 CFR Part 807.92.

| Assigned 510(k) Number: | K041043 |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary Preparation: | April 20, 2004 |
| Manufacturer: | Pharmacia Deutschland GmbH,<br>Diagnostics Division<br>Munzinger Strasse 7<br>D-79111 Freiburg, Germany |
| Company Contact Person: | Michael Linss<br>Manager, Compliance and Quality<br>Pharmacia Deutschland GmbH<br>Diagnostics Division<br>Munzinger Strasse 7<br>D-79111 Freiburg, Germany<br>[phone](Phone)<br>[phone] (Fax) |
| Device Name: | Varelisa PR3 ANCA |
| Common Name: | test system, antineutrophil cytoplasmic<br>antibodies (anca) |
| Classification | |

### Classification

| Product Name | Product Code | Class | CFR |
|-------------------|--------------|-------|----------|
| Varelisa PR3 ANCA | MOB | II | 866.5660 |

### Substantial Equivalence to

INOVA QUANTA Lite™ PR-3

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# Intended Use Statement

The Varelisa PR3 ANCA EIA kit is designed for the semi-quantitative and qualitative determination of proteinase 3 anti neutrophil cytoplasmic antibodies (PR3 ANCA) in human serum or plasma to aid in the diagnosis of Wegener's granulomatosis.

# General Description of the Device

Varelisa PR3 ANCA is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of PR3 ANCA in human serum or plasma.

The test kit contains microplate strips coated with human purified PR3 antigen, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, sample diluent and wash buffer.

# Varelisa® PR3 ANCA Test Principle

Varelisa PR3 ANCA is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of PR3 ANCA in human serum or plasma. The wells of a microplate are coated with human PR3 antigen, Antibodies specific for PR3 present in the patient sample bind to the antigen.

In a second step the enzyme labeled second antibody (conjugate) binds to the antigen-antibody complex which leads to the formation of an enzyme labeled conjugate-antibody-antigen complex. The enzyme labeled antigen-antibody complex converts the added substrate to form a colored solution.

The rate of color formation from the chromogen is a function of the amount of conjugate complexed with the bound antibody and thus is proportional to the initial concentration of the respective antibodies in the patient sample.

# Device Comparison

Both assays (the predicate and the new device) are indirect noncompetitive enzyme immunoassays for the semi-quantitative and qualitative determination of IgG autoantibodies to protease 3 (PR3) in human serum. Both assays recommend the same sample dilutions and use comparable enzyme-linked conjugates and antigens. Based on currently available data from the literature the measuring of the autoantibodies to PR3 provides aid in the diagnosis of Wegener's granulomatosis.

A difference between both assays is that the INOVA QUANTA Lite™ PR-3 is only recommended for use in serum specimen while the PHARMACIA Varelisa PR3 ANCA is intended for use with serum and plasma. The cut-off in the INOVA QUANTA Lite™ PR-3 is evaluated by using a low and a high positive Standard and a grading of the results in negative, weak, moderate and strong positive. The PHARMACIA Varelisa PR3 ANCA uses a set of six Calibrators and classifies the results as negative, equivocal and positive.

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# Laboratory equivalence

The comparability of QUANTA Lite™ PR-3 and Varelisa PR3 ANCA is supported by a data set including

- · results obtained within a comparison study analyzing positive, equivocal and negative sera.
- · results obtained for externally defined Calibrators and clinically defined sera.
- results obtained for samples from apparently healthy subjects (normal population).

The data show that the assay performs as expected from the medical literature.

In summary, all available data support that the new device, PHARMACIA Varelisa PR3 ANCA is substantially equivalent to the predicate device, INOVA QUANTA Lite™ PR-3, and that the new device performs according to state-ofthe-art expectations.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL - 2 2004

Mr. Michael Linss Manager, Compliance and Quality Pharmacia Deutschland GmgH Diagnostics Division Munzinger Strasse 7 D-79111 Freiburg, Germany

k041043 Re: Trade/Device Name: Varelisa® PR3 ANCA Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MOB Dated: April 20, 2004 Received: April 23, 2004

Dear Mr. Linss:

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). 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

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Page 2

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/dsma/dsmamain.html.

Sincerely yours,

Robert L. Becker, Jr.

Robert L. Becker, Jr., M.D., Ph. 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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Varelisa® PR3 ANCA - New Device 510(k) Submission Section 1. Indications for Use Statement

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

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Device Name: Varelisa® PR3 ANCA

### Intended Use Statement

The Varelisa PR3 ANCA EIA kit is designed for the semiquantitative and qualitative The Varensa FRS ANCA Elli neutrophil cytoplasmic antibodies (PR3 ANCA) in human serum or protemase -> and notal of Wegener's granulomatosis.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|-------------------------------------------------------------------|-------------------------------------------------------------------|
| Prescription Use | <span style="text-decoration: overline;">✓</span> |
| (Per 21 CFR 801.109) | |
| | OR |
| | Over-The-Counter Use |
| <span style="text-decoration: overline;"><i>Thane Chan</i></span> | |
| | <span style="text-decoration: overline;">Division Sign-Off</span> |
| Office of In Vitro Diagnostic Device | |

Evaluation and Safety

510(k)________________________________________________________________________________________________________________________________________________________________________

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