VARELISA MPO ANCA, MODEL 17648/17696

K041040 · Sweden Diagnostics (Germany) GmbH · MOB · Jun 16, 2004 · Immunology

Device Facts

• Record ID: K041040
• Device Name: VARELISA MPO ANCA, MODEL 17648/17696
• Applicant: Sweden Diagnostics (Germany) GmbH
• Product Code: MOB · Immunology
• Decision Date: Jun 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The Varelisa MPO ANCA EIA kit is designed for the semi-quantitative and qualitative determination of myeloperoxidase anti-neutrophil cytoplasmic antibodies (MPO ANCA) in human serum or plasma to aid in the diagnosis of certain autoimmune vasculitides such as microscopic polyangiitis, and crescentic glomerulonephritis.

Device Story

Varelisa MPO ANCA is an indirect noncompetitive enzyme immunoassay (EIA) for detecting MPO ANCA antibodies in human serum or plasma. The device uses microplate strips coated with human purified MPO antigen. Patient samples are added; MPO-specific antibodies bind to the antigen. An enzyme-labeled conjugate is added, binding to the antigen-antibody complex. A substrate is introduced, which the enzyme converts into a colored solution. The rate of color formation is proportional to the concentration of MPO ANCA in the sample. The assay is performed in a laboratory setting by trained personnel. Results are interpreted by healthcare providers to aid in the diagnosis of autoimmune vasculitides. The device provides a semi-quantitative and qualitative assessment, helping clinicians identify patients with specific autoimmune conditions.

Clinical Evidence

Clinical comparability supported by a data set including a comparison study of positive, equivocal, and negative sera, analysis of externally defined calibrators, clinically defined sera, and samples from healthy subjects. Data indicate the assay performs according to state-of-the-art expectations and medical literature.

Technological Characteristics

Indirect noncompetitive enzyme immunoassay (EIA). Components: microplate strips coated with human purified MPO antigen, calibrators, positive/negative controls, enzyme-labeled conjugate, substrate, stop solution, sample diluent, wash buffer. Analyte: MPO ANCA. Sample types: human serum or plasma.

Indications for Use

Indicated for use as an aid in the diagnosis of autoimmune vasculitides, specifically microscopic polyangiitis and crescentic glomerulonephritis, in patients suspected of these conditions.

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 MPO (k955022)

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 This Summary of Safety and of The Safety Medical Devices Act of 1990 (SMDA 1990) and 21 CFR Part 807.92.

| Assigned 510(k) Number: | K041040 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 & 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® MPO ANCA |
| Common Name: | myeloperoxidase anti neutrophil cytoplas-<br>matic antibodies immunological test system |

# Classification

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

## Substantial Equivalence to

INOVA QUANTA Lite™ MPO

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#### Intended Use Statement

The Varelisa MPO ANCA EIA kit is designed for the semi-quantitative and The varensa mro of myeloperoxidase anti neutrophil cytoplasmatic antibodies (MPO ANCA) in human serum or plasma to aid in the diagnosis of antiooules (11) O Free vasculitides such as microscopic polyangiitis, and crescentic glomerulonephritis.

# General Description of the New Device

Varelisa MPO ANCA is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of MPO ANCA in human serum or plasma. Antibodies specific for MPO present in the patient sample bind to the antigen.

The test kit contains microplate strips coated with human purified MPO ANCA antigen, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, Sample Diluent and wash buffer.

# Test Principle of the New Device

Varelisa MPO ANCA is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of MPO ANCA in human serum or plasma. The wells of a microplate are coated with human purified MPO antigen. Antibodies specific for MPO 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 determination of IgG autoantibodies to myeloperoxidase (MPO) 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 MPO provides aid in the diagnosis of certain autoimmune vasculitides.

A difference between both assays is that the INOVA QUANTA Lite™ MPO is only recommended for use in serum specimen while the PHARMACIA Varelisa MPO ANCA is intended for use with serum and plasma. The cut-off in the INOVA QUANTA Lite™ MPO 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 MPO 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 INOVA QUANTA Lite™ MPO and Pharmacia Varelisa MPO 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 MPO ANCA Assay is substantially equivalent to the predicate device, INOVA QUANTA Lite™ MPO Assay, and that the new device performs according to state-of-the-art expectations.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or waves, stacked on top of each other.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Michael Linss, Ph.D. Manager, Compliance & Quality Sweden Diagnostics (Germany) GmbH Munzinger Strasse 7 D-79111 Freiburg

JUN 1 6 2004

k041040 Trade/Device Name: Varelisa® MPO ANCA Regulation Number: 21 CFR § 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: II Product Code: MOB Dated: April 20, 2004 Received: April 23, 2004

Dear Dr. Linss:

Re:

We have reviewed your Section 510(k) premarket notification of intent to market the device w & Howean John 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 for associoior 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 or any I vith 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 OFF Part 820), 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.

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Page 2

If you desire specific information about the application of labeling requirements to your device, If you desire specific information as advertising of your device, please contact the Office of In of questions on the promotion and Safety at [phone]. Also, please note the V III Diagnostic Dorio Branding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may outlif other general messages 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,

Joseph L. Arlott

Joseph L. Hackett, Ph.D. Acting 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

5 l 0(k) Number: _____________________________________________________________________________________________________________________________________________________________

Device Name: Varelisa® MPO ANCA

#### Indications For Use:

The Varelisa MPO ANCA EIA kit is designed for the semi-quantitative and The Valensa NY O TIYOF Enternations anti neutrophil cytoplasmatic antibodies (MPO ANCA) in human serum or plasma to aid in the diagnosis of certain (MI O ANCA) in haman berain as microscopic polyangiitis, and crescentic glomerulonephritis.

Marie M Chan
Division Sign-Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k041640

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

(21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)