(53 days)
Eu-tTG®IgA assay is a qualitative ELISA test for the in vitro diagnostic detection of IgA antibody against the enzyme tissue Transglutaminase in human serum. This test is designed for use as an aid in the diagnosis of Celiac Disease.
Enzyme Immunoassay Kit
The provided text is a 510(k) clearance letter from the FDA for a device called "Eu-tTG® IgA Assay." This document is a regulatory communication, not a study report or clinical trial summary.
Therefore, it does not contain the information requested regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about training sets and ground truth establishment.
The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is "substantially equivalent" to legally marketed predicate devices for the indicated use as "an aid in the diagnosis of Celiac Disease."
To obtain the requested information, one would need to consult the actual 510(k) submission document (K994379) itself, which would include the study data and performance claims.
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FEB 1 8 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Eurospital S.p.A. c/o Gary Lehnus, Ph.D. Scimedx Corporation 400 Ford Road Denville, New Jersey 07834
Re: K994379 Trade Name: Eu-tTG® IgA Assay Regulatory Class: II Product Code: MVM Dated: December 22, 1999 Received: December 27, 1999
Dear Dr. Lehnus:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page _ I_of_l_
510(k) Number (if known):
Device Name: Eu-tTG®IgA Assay_
Enzyme Immunoassay Kit
Indications For Use:
Eu-tTG®IgA assay is a qualitative ELISA test for the in vitro diagnostic detection of IgA antibody against the enzyme tissue Transglutaminase in human serum. This test is designed for use as an aid in the diagnosis of Celiac Disease.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Malin
(Division Sign-Off)
Division of Clinical Laboratory Devices K994379
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
§ 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).