(136 days)
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.
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I am sorry, but the provided text does not contain the information requested in your prompt. The document is an FDA clearance letter for a medical device (EUROIMMUN Endomysium IFA kit) and primarily discusses its regulatory classification and substantial equivalence to a predicate device. It does not include details about acceptance criteria, study designs, sample sizes, ground truth establishment, or expert qualifications for performance evaluation.
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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 (240) 276-0484. 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 (800) 638-2041 or (240) 276-3150 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
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
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).(b)
Classification. Class II (performance standards).