(325 days)
Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of IgA and IgG antibodies to synthetic human tissue transglutaminase (1TG) and deamidated gliadin peptide (DGP) in human serum to aid in the diagnosis of celiae disease (CD) in conjunction with other laboratory tests and clinical findings.
Enzyme linked immunoassay (ELISA)
The provided text details the FDA's clearance of the ImmuLisa Enhanced Celiac Fusion (tTG/DGP) IgA/IgG Antibody ELISA for aiding in the diagnosis of celiac disease. However, the document does not contain specific acceptance criteria or a study summary that details the device's performance against such criteria. The document is primarily an FDA clearance letter and an "Indications for Use" statement.
Therefore, I cannot provide the requested information from the given text.
To address the prompt fully, I would need a study report or a different document detailing the performance evaluation of the ImmuLisa Enhanced Celiac Fusion ELISA.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 25, 2013
IMMCO DIAGNOSTICS, INC. KEVIN LA WSON CHIEF REGULATORY OFFICER 60 PINEVIEW DR. BUFFALO NY 14228-2120
Re: K123713
Trade/Device Name: ImmuLisa Enhanced Celiac Fusion (tTG/DGP) IgA/IgG Antibody ELISA Regulation Number: 21 CFR 866.5750 Regulation Name: Radioallergosorbent (RAST) immunological test system Regulatory Class: II Product Code: MVM, MST Dated: July 26, 2013 Received: September 23, 2013
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. Iisting of devices, good manufacturing practice. labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to 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 Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809). please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.bym.
Sincerely vours.
Reena Philip -S
for
Maria M. Chan, Ph.D. Director
Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K123713
Device Name
ImmuLisa Enhanced™ Celiac Fusion (tTG/DGP) IgA/IgG Antibody ELISA
Indications for Use (Describe)
Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of IgA and IgG antibodies to synthetic human tissue transglutaminase (1TG) and deamidated gliadin peptide (DGP) in human serum to aid in the diagnosis of celiae disease (CD) in conjunction with other laboratory tests and clinical findings.
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Reena Pa
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
§ 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).