(180 days)
The QUANTA Plex™ Celiac IgA Profile is a fluorescent immunoassay for the semi-quantitative detection of IgA anti-human tissue transglutaminase (htTG) and antideamidated gliadin peptide (DGP) antibodies, and the detection of an insufficient amount of IgA, in human serum. The presence of these antibodies in conjunction with other laboratory and clinical findings is an aid in the diagnosis of the gluten sensitive enteropathy celiac disease. Insufficient IgA indicates that there is not enough IgA to allow detection of IgA anti-htTG or anti-DGP.
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I am sorry, but the provided text is an FDA 510(k) clearance letter and does not contain the specific information requested regarding the acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device. The document primarily focuses on the regulatory clearance of the QUANTA Plex™ Celiac IgA Profile and its indications for use, stating that it has been deemed "substantially equivalent" to legally marketed predicate devices.
Therefore, I cannot extract the requested information from this document.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
INOVA Diagnostics, Inc. c/o Mr. Brys Myers Vice President 9900 Old Grove Road San Diego, CA 92131-1234
JUN 2 0 2007
Re: K063818
Trade/Device Name: QUANTA Plex™ Celiac IgA Profile Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MVM. MST Dated: June 13, 2007 Received: June 13, 2007
Dear Mr. Myers:
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.org set forth in the quality systems (QS) 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). 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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510(k) Number (if known):_长0638/8
Device Name: QUANTA Plex™ Celiac IgA Profile
Indications For Use:
The QUANTA Plex™ Celiac IgA Profile is a fluorescent immunoassay for the semi-quantitative detection of IgA anti-human tissue transglutaminase (htTG) and antideamidated gliadin peptide (DGP) antibodies, and the detection of an insufficient amount of IgA, in human serum. The presence of these antibodies in conjunction with other laboratory and clinical findings is an aid in the diagnosis of the gluten sensitive enteropathy celiac disease. Insufficient IgA indicates that there is not enough IgA to allow detection of IgA anti-htTG or anti-DGP.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use X Use (Per 21 CFR 801.109) 2-96
Over-The Counter
(Optional Format 1-
Maria McLen
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safe:
510(k) 063818
§ 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).