EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM

K051489 · Euroimmun Us, LLC · MOB · Feb 16, 2006 · Immunology

Device Facts

• Record ID: K051489
• Device Name: EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM
• Applicant: Euroimmun Us, LLC
• Product Code: MOB · Immunology
• Decision Date: Feb 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

This test kit is designed for qualitatively or semi-quantitatively determination of anti-Neutrophil cytoplasmic antibodies (ANCA) in serum. These antibodies are associated with Wegener's granulomatosis, microscopic arteriitis, Churg-Strauss syndrome and classic polyarteriitis nodosa. For in vitro diagnostics use.

Device Story

The EUROIMMUN ANCA IFA Granulocyte BIOCHIP MOSAIC™ Test System is an in vitro diagnostic device used to detect anti-Neutrophil cytoplasmic antibodies (ANCA) in human serum. The system utilizes indirect immunofluorescence (IFA) on BIOCHIP substrates containing granulocytes. The device is intended for use by laboratory professionals in a clinical setting. The test process involves incubating patient serum with the BIOCHIP, followed by the addition of a fluorescently labeled secondary antibody. The resulting fluorescence pattern is observed by a clinician using a fluorescence microscope. The presence and pattern of fluorescence provide qualitative or semi-quantitative information regarding the presence of ANCA, which assists clinicians in the diagnosis of systemic vasculitis conditions such as Wegener's granulomatosis, microscopic arteriitis, Churg-Strauss syndrome, and classic polyarteriitis nodosa. The output supports clinical decision-making by identifying specific autoantibody profiles associated with these autoimmune diseases.

Clinical Evidence

Clinical performance evaluated on 342 samples (153 clinically diagnosed ANCA-related disease, 189 normal donors). Clinical sensitivity 98.0%, clinical specificity 98.4%, overall agreement 98.2%. Method comparison against predicate on 270 samples showed 99.6% overall agreement. Analytical performance included precision/reproducibility studies (intra-assay, inter-assay, inter-lot) and cross-reactivity testing against CDC ANA panel and other autoimmune conditions (SLE, UC, Crohn's, PBC) with no interference or false positives noted.

Technological Characteristics

The device is an indirect immunofluorescence (IFA) assay utilizing BIOCHIP technology. It consists of substrates containing granulocytes for the detection of autoantibodies. It is an in vitro diagnostic test system classified under 21 CFR 866.5660.

Indications for Use

Indicated for the qualitative or semi-quantitative detection of anti-Neutrophil cytoplasmic antibodies (ANCA) in human serum to aid in the diagnosis of Wegener's granulomatosis, microscopic arteriitis, Churg-Strauss syndrome, and classic polyarteriitis nodosa.

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).

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the words "HEALTH & HUMAN SERVICES USA" written around the perimeter.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 6 2006

EUROIMMUN US, LLC c/o Ms Kathryn Kohl Managing Director Operations, Scientific & Regulatory Tek Campus of Morris County 429 Rockaway Valley Rd. Boonton TWP, NJ 07005

Re: k051489

Ros I 107
Trade/Device Name: EUROIMMUN ANCA IFA Granulocyte BIOCHIP MOSAIC™ Test System Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies, immunological test system Regulatory Class: Class II Product Code: MOB Dated: May 31, 2005 Received: June 14, 2005

Dear Ms. Kohl:

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 nrior 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 Eederal 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 forth in the quality

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systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation systems (QB) 105 (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This icher with anow you to ogen mailing of substantial equivalence of your device to a legally premits to notification: "The PDF maille sification 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 rryou desire specific at [phone]. Also, please note the regulation entitled, connact the Office of Connect notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general information on your 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

Robert L. Becker, Jr., M.D., Ph.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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## Indication of Use Statement

510(k) Number (if known):

## EUROIMMUN ANCAIFA Granulocyte BIOCHIP Mosaic™ Device Name:

Indications for Use:

## Intended use:

This test kit is designed for qualitatively or semi-quantitatively determination of anti-Neutrophil cytoplasmic antibodies (ANCA) in serum. These antibodies are associated with Wegener's granulomatosis, microscopic arteriitis, Churg-Strauss syndrome and classic polyarteriitis nodosa. For in vitro diagnostics use.

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

Over-the-Counter Use (21 CFR § 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mona Chan
Sign-Off

Tice of In Vitro Diagnostic Device T cluation and Safety

K051489