EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.

K060700 · Euroimmun Us, LLC · MOB · Sep 8, 2006 · Immunology

Device Facts

• Record ID: K060700
• Device Name: EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.
• Applicant: Euroimmun Us, LLC
• Product Code: MOB · Immunology
• Decision Date: Sep 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

This test kit is designed for the determination of anti-proteinase 3 antibodies (PR3) in human serum and plasma. This test is used as an aid in the differential diagnosis of Wegener's granulomatosis and other autoimmune vasculitides, in conjunction with other laboratory and clinical findings. This test kit is designed for the determination of anti-myeloperoxidase antibodies (MPO) in human serum and plasma. This test is used as an aid in the differential diagnosis of microscopic polyangitis, Churg-Strauss syndrome and other autoimmune vasculitides, in conjunction with other laboratory and clinical findings.

Device Story

The EUROIMMUN Anti-PR3 and Anti-MPO ELISA IgG kits are in vitro diagnostic assays for detecting autoantibodies in human serum or plasma. The device utilizes microwell strips coated with purified PR3 or MPO antigen. Patient samples are diluted and added to the wells; if specific autoantibodies are present, they bind to the immobilized antigen. After washing, a rabbit anti-human IgG horseradish peroxidase (HRP) conjugate is added, followed by a TMB/H2O2 substrate. The HRP enzyme catalyzes a colorimetric reaction proportional to the amount of bound antibody. A stop solution terminates the reaction, and optical density is measured via spectrophotometry at 450 nm. The device is intended for use in clinical laboratories by trained personnel. Results are interpreted as negative or positive based on a 20 RU/mL cut-off, aiding clinicians in the differential diagnosis of autoimmune vasculitides. The semi-quantitative output supports clinical decision-making by confirming the presence of specific ANCA-associated antibodies.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

ELISA-based immunological test system. Analyte: IgG antibodies against Proteinase 3 (PR3) or Myeloperoxidase (MPO). Sample type: human serum and plasma. Regulatory class II, product code MOB.

Indications for Use

Indicated for the detection of anti-PR3 or anti-MPO IgG antibodies in human serum and plasma as an aid in the differential diagnosis of autoimmune vasculitides, including Wegener's granulomatosis, microscopic polyangiitis, and Churg-Strauss syndrome, in conjunction with other clinical and laboratory findings. 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).

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 and Human Services. The logo consists of a stylized eagle or bird symbol on the right side. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# SEP - 8 2006

EUROIMMUN US, LLC c/o Ms. Kathryn Kohl Managing Director Tek Campus of Morris County 429 Rockaway Valley Rd. U1200 Boonton TWP. NJ 07005

Re: k060700

Trade/Device Name: EUROIMMUN anti-Proteinase 3 (PR3) ELISA IgG and EUROIMMUN anti-Myeloperoxidase (MPO) ELISA IgG Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: Class II Product Code: MOB Dated: March 10, 2006 Received: March 15, 2006

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 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance 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/industry/support/index.html.

Sincerely yours,

ie Chan for
Sr. Robert Becker

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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## ATTACHMENT 1

PR3:

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): k060700

Device Name:

Anti-Proteinase 3 (PR3) ELISA IgG

Indications For Use:

This test kit is designed for the determination of anti-proteinase 3 antibodies (PR3) in human serum and plasma. This test is used as an aid in the differential diagnosis of Wegener's granulomatosis and other autoimmune vasculitides, in conjunction with other laboratory and clinical findings.

Prescription Use × (Part 21 CFR 801 Subpart D) ANDYOR

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 (OIVD)

Mana-Chen

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

51000 Koko 700

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MPO:

#### INDICATIONS FOR USE STATEMENT

510(k) Number (if known): k060700

Device Name: Anti-Myeloperoxidase (MPO) ELISA IgG

Indications For Use:

This test kit is designed for the determination of anti-myeloperoxidase antibodies (MPO) in human serum and plasma. This test is used as an aid in the differential diagnosis of microscopic polyangitis, Churg-Strauss syndrome and other autoimmune vasculitides, in conjunction with other laboratory and clinical findings.

Prescription Use (Part 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 (OIVD)

Mana Chan

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**Division Sign Off**

**Division Sign**

Office of In Vitro Diagnostic
Device Evaluation and Safety

51009 K.06700