(49 days)
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No
The summary describes a standard ELISA assay, which is a biochemical test and does not involve AI or ML. There are no mentions of AI, ML, image processing, or any other indicators of AI/ML technology.
No
The device is described as an ELISA for the detection of antibodies to aid in diagnosis, not for treating a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the detection of antibodies by this device is "an aid in diagnosis of certain gluten sensitive enteropathies." This indicates its role in the diagnostic process.
No
The device is an Enzyme Linked Immunosorbant Assay (ELISA), which is a laboratory test involving physical reagents and procedures, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "Enzyme Linked Immunosorbant Assay (ELISA) for the semiquantitative detection of IgA antibodies to human tissue transglutaminase (endomysium) in human serum." This involves testing a sample taken from the human body (serum) in vitro (outside the body).
- Purpose: The purpose is to "aid in diagnosis of certain gluten sensitive enteropathies such as celiac disease and dermatitis herpetiformis." This diagnostic purpose is a key characteristic of IVDs.
The definition of an IVD generally involves devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device fits that description perfectly.
N/A
Intended Use / Indications for Use
for the Assay An Enzyme Linked Immunosorbant IgA ELISA for the semi-quantitative Detection of human tissue transglutaminase (endomysium) in human serum. Detection of these antibodies is an aid in diagnosis of certain gluten sensitive enteropathies such as celiac disease and dermatitis herpetiformis.
Product codes
MVM
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of an eagle.
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
K011566 Re:
Trade Name: INOVA QUANTA Lite h-tTG (Human Tissue Transglutaminase) IgA ELISA Regulation Number: 21 CFR § 866.5660 Regulatory Class: II Product Code: MVM Dated: June 13, 2001 Received: June 15, 2001
JUL = 9 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 Cosmetic Provisions of the Act. The general controls provisions of the Act include requirements for annual provisions of the Pres. "Preces, 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 This letter will allow you to begin makeung your dovice of your device to a legally marketed
notification. The FDA finding of substantial equipe and wine segmine your device notification. The FDA Inding of Substantal equivaliates of your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice for your devices), please contact the Office of Compliance at
additionally 809.10 for in vitro diagnostic devices), please contact the Office of additionally 809.10 for in villo diagnostic use nows, promotion and advertising of your device,
(301) 594-4588. Additionally, for questions on the promotion and advertising (301) 594-4588. Additionally, for questions on the pressed and please note the regulation please contact the Office of Comphanee at (301) - 1 Total of (21CFR 807.97). Other general
entitled, "Misbranding by reference to premarket notification the Division of Smal entitled, "Misbranding by releite to premance the Act may be obtained from the Division of Small
information on your responsibilities under the 1000 (2001) 143-6597 or at its information on your responsibilities and its toll-free number (800) 638-2041 or (301) 443-6597 or at its Mianufacturers 7135f3fdf100 av ttb 100 v/cdrh/dsma/dsmamain.html".
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
2
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
IgA ELISA Device Name: h-tTG (human tissue transglutaminase)
Indications For Use:
semifor the Assay Immunosorbant An Enzyme Linked Immunosorbant Research (endomysium) in human serum. Detection of these antibodies is an
(endomysium) in human serum. Aluten sensitive enteropathies such as (endomysium) in human serum. Defection of chebe and as a
s (endomysium) in humating berotiformis. aid in diagnosis of certain graces.
celiac disease and dermatitis herpetiformis.
J. Hackett
(Division Sian-Division of Clinical Laboratory Devices
510(k) Number
(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)
00
Over-the-counter Use
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