(138 days)
The TheraTest EL-tTG™ IgA/IgG and TheraTest EL-GLIATM IgA/IgG Kits are enzyme-linked immunosorbent assay (ELISA) test systems for the semi-quantitative measurement of IgA and IgG anti-tissue transglutaminase (tTG) and anti-gliadin antibodies in human serum. Detection and semi-quantitation of these antibodies is intended to aid the diagnosis of patients with gluten sensitive enteropathies: celiac disease and dermatitis herpetiformis, in conjunction with other clinical findings and laboratory tests.
enzyme-linked immunosorbent assay (ELISA) test systems for the semi-quantitative measurement of IgA and IgG anti-tissue transglutaminase (tTG) and anti-gliadin antibodies in human serum.
The provided text is a 510(k) premarket notification letter from the FDA regarding two ELISA test systems (TheraTest EL-tTG™ IgA/IgG and TheraTest EL-Glia™ IgA/IgG) for aiding in the diagnosis of celiac disease and dermatitis herpetiformis.
However, the provided document does not contain any information about acceptance criteria, device performance studies, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance.
The letter is a notification of substantial equivalence to predicate devices, allowing the manufacturer to market the device, subject to general controls. It does not include specific study results or performance data that would detail acceptance criteria and a study proving the device meets them.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study that proves the device meets them based on the provided text. This information would typically be found in the 510(k) submission itself, or in accompanying performance data summaries, which are not part of this letter.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV - 5 2007
TheraTest Laboratories, Inc. c/o Marius Teodorescu, MD, PhD President and CEO 1111 North Main Street Lombard, IL 60148
Re: K071692
Trade/Device Name: EL-tTGTM IgA/IgG and EL-Glia™ IgA/IgG Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MVM, MST Dated: October 01, 2007 Received: October 02, 2007
Dear Dr. Teodorescu:
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 (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The
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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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 Becker
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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Attachment 2
Indications for Use Statement
TheraTest EL-tTGTM IgA/IgG and TheraTest EL-Glia™ IgA/IgG
510(k)Number 071692
TheraTest EL-tTGTM IgA/IgG Device Name:
TheraTest EL-Glia™ IgA/IgG
Indications for Use. The TheraTest EL-tTG™ IgA/IgG and TheraTest EL-GLIATM IgA/IgG Kits are enzyme-linked immunosorbent assay (ELISA) test systems for the semi-quantitative measurement of IgA and IgG anti-tissue transglutaminase (tTG) and anti-gliadin antibodies in human serum. Detection and semi-quantitation of these antibodies is intended to aid the diagnosis of patients with gluten sensitive enteropathies: celiac disease and dermatitis herpetiformis, in conjunction with other clinical findings and laboratory tests.
m Chan
Division Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Safety
071692 510(k) --
Prescription use X = = =
AND/OR
Over-the-counter use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of in vitro Diagnostic devices (OIVD)
§ 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).