(49 days)
for the semi-quantitative detection of IgG antibodies to tissue transglutaminase (endomysium) in human serum. Detection of these antibodies, in conjunction with IgA antibodies, is an aid in diagnosis of certain gluten sensitive enteropathies such as celiac disease and dermatitis herpetiformis. This test is intended for providing added sensitivity when testing IgA deficient patients.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding the "INOVA QUANTA Lite h-tTG (Human Tissue Transglutaminase) IgG ELISA" device. This document is a regulatory approval letter and does not contain the detailed study information required to answer the questions comprehensively. It confirms the device's substantial equivalence to a predicate device and its intended use, but it does not describe the specific performance studies, acceptance criteria, or ground truth establishment in the level of detail requested.
Therefore, I cannot provide all the requested information from the given text. However, I can extract the following:
Device Name: INOVA QUANTA Lite h-tTG (Human Tissue Transglutaminase) IgG ELISA
Indications For Use: For the semi-quantitative detection of IgG antibodies to tissue transglutaminase (endomysium) in human serum. Detection of these antibodies, in conjunction with IgA antibodies, is an aid in diagnosis of certain gluten sensitive enteropathies such as celiac disease and dermatitis herpetiformis. This test is intended for providing added sensitivity when testing IgA deficient patients.
To answer your questions, the relevant information would typically be found in the 510(k) submission summary or the study reports themselves, which are not included in this document.
Based on the provided text, I cannot answer the following questions:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a traditional symbol of medicine. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Brys C. Myers Manager, Regulatory Affairs INOVA Diagnostics, Inc. 10180 Scripps Ranch Boulevard San Diego, California 92131-1234
JUL - 9 2001
K011570 Re:
Trade Name: INOVA QUANTA Lite h-tTG (Human Tissue Transglutaminase) IgG ELISA Regulation Number: 21 CFR § 866.5660 Regulatory Class: II Product Code: MVM Dated: June 20, 2001 Received: June 25, 2001
Dear Mr. Myers:
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 notification. The I D7X maning of vaculantar vqur device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for mirro diagnestions on the promotion and advertising of your device, (301) 594-4500. Truditionally, 10. quee at (301) 594-4639. Also, please note the regulation prease contact the Office or Germarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small milliation on your responsionials and the enember (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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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510(k) Number (if known):
Device Name: h-tTG (human tissue transglutaminase) IgG ELISA
Indications For Use:
for the semi-Immunosorbant Assay (ELISA) Linked Enzyme An quantitative detection of IgG antibodies to tissue transglutaminase (endomysium) in human serum. Detection of these antibodies, in conjunction with IgA antibodies, is an aid in diagnosis of certain gluten sensitive enteropathies such as celiac disease and dermatitis herpetiformis. This test is intended for providing added sensitivity when testing IgA deficient patients.
J. Hackett
510(k) Numbe
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
For Prescription Use only
(Per 21 CFR801.109) - ✓
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).