IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA

{0}------------------------------------------------ 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wavy lines extending from its body. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 MAR - 5 2004 Mr. Kevin J. Lawson Dircctor of Regulatory Affairs IMMCO Diagnostics, Inc. 60 Pineview Drive Buffalo, NY 14228 k040095 Re: Trade/Device Name: ImmuLisa Anti-human tissue Transglutaminase (human tTG) IgG ELISA Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MVM Dated: February 20, 2004 Received: February 24, 2004 Dear Mr. Lawson: 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practicc requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {1}------------------------------------------------ ## Page 2 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 premaince modicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific information about the application of labeling requirements to your device, 11 Juestions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. 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 I va inay of Small Manufacturers, International and Consumer 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, Joseph L. Hackett Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## INDICATIONS FOR USE STATEMENT 510(k) Number (if known): K_ 0400 96 K. 640096 Device Name: ImmuLisa Anti-human tissue Transglutaminase (human tTG) IgG ELISA An enzyme linked immunoassay (ELISA) for the detection and semi-Indications For Use: quantitation of anti-human Tissue Transglutaminase IgG antibodies in human serum to aid in the diagnosis of celiac disease (CD) in patients with IgA deficiency. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) ﮯ Over-The-Counter Use _ OR (Optional Format 1-2-96) Maria Chan Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K040091 {3}------------------------------------------------ ## INDICATIONS FOR USE STATEMENT 510(k) Number (if known): K.DY0095____________________________________________________________________________________________________________________________________________ ImmuLisa Anti-human tissue Transglutaminase (hu tTG) Total Device Name: IgA/IgG Antibody ELISA Indications For Use: An enzyme linked immunoassay (ELISA) for the detection and An chilymo intitled of IgA and IgG antibodies to human tissue semi-quantitation of ig/Pana is ci citia in diagnosis of Celiac Disease (CD). (Please DO NOT WRITE BE'LOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ## Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) . OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96) Maria Chan Division Sign-Off .Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K040095