EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT

K061408 · Euroimmun Us, LLC · MVM · Oct 5, 2006 · Immunology

Device Facts

• Record ID: K061408
• Device Name: EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT
• Applicant: Euroimmun Us, LLC
• Product Code: MVM · Immunology
• Decision Date: Oct 5, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The EUROIMMUN Endomysium IFA kit is designed for the semi-quantitative and qualitative determination of antibodies against Endomysium (EMA) in human serum. This test is used as an aid in the diagnosis of gluten-sensitive enteropathies associated with celiac disease in conjunction with other laboratory and clinical findings.

Device Story

In vitro diagnostic test kit; utilizes monkey esophagus tissue substrate for indirect immunofluorescence (IFA) assay. Patient serum samples applied to substrate; if anti-endomysium antibodies present, they bind to tissue. Fluorescently labeled anti-human globulin conjugate added; binds to patient antibodies. Visualized via fluorescence microscopy. Used in clinical laboratories by trained personnel. Results interpreted by clinicians alongside clinical findings to support celiac disease diagnosis.

Clinical Evidence

No clinical data provided in the summary document; device relies on established immunological principles for the detection of autoantibodies.

Technological Characteristics

Substrate: frozen primate (monkey) esophagus sections on BIOCHIPs. Detection: FITC-labeled goat anti-human IgA. Energy source: fluorescent microscope (100W mercury vapor or LED, 488nm excitation). Format: TITERPLANE reagent tray system. Qualitative/semi-quantitative IFA.

Indications for Use

Indicated for semi-quantitative and qualitative detection of anti-endomysium (EMA) antibodies in human serum to aid in the diagnosis of gluten-sensitive enteropathies associated with celiac disease.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

007 - 5 2006

Re: k061408

Trade/Device Name: EUROIMMUN Endomysium IFA: Esophagus (Monkey) Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: Class II Product Code: MVM Dated: May 19, 2006 Received: May 22, 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,

Robert L. Besten/

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 STATEMENT

510(k) Number (if known): k061408

Device Name: Endomysium IFA: Esophagus (Monkey)

Indications For Use:

The EUROIMMUN Endomysium IFA kit is designed for the semi-quantitative and qualitative determination of antibodies against Endomysium (EMA) in human serum. It is used as an aid in the diagnosis of gluten-sensitive enteropathies associated with celiac disease in conjunction with other laboratory and clinical findings.

Prescription Use X Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter

(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)

Maria Chan

Division Sign-Off

Office of In Vitro Dlagnostic Device Evaluation and Safety

510(k) K061404