(51 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, or related concepts.
No
This device is an in vitro diagnostic assay used for detection, which aids in diagnosis. It does not provide therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" states that the detection of antibodies by this device is "an aid in diagnosis of certain gluten sensitive enteropathies such as celiac disease and dermatitis herpetiformis," which clearly indicates a diagnostic purpose.
No
The device description clearly states it is an Enzyme Linked Immunosorbant Assay (ELISA), which is a laboratory test involving physical reagents and equipment, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "semi-quantitative detection of IgA antibodies to tissue transglutaminase (endomysium) in human serum." This involves testing a sample taken from the human body (serum) in vitro (outside the body).
- Aid in Diagnosis: The intended use also states that the detection of these antibodies is an "aid in diagnosis of certain gluten sensitive enteropathies." This clearly indicates a diagnostic purpose.
- Device Description: The device is described as an "Enzyme Linked Immunosorbant Assay (ELISA)," which is a common type of laboratory test performed in vitro.
These points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnostic, monitoring, or screening purposes.
N/A
Intended Use / Indications for Use
An Enzyme Linked Immunosorbant Assay (ELISA) for the semi-IqA antibodies tissue quantitative detection of of to transqlutaminase (endomysium) in human serum. Detection of these antibodies is an aid in diagnosis of certain gluten sensitive 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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).
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right and appears to be in flight.
AUG 27 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Brys C. Myers Requlatory Affairs Officer INOVA Diagnostics, Inc. 10180 Scripps Ranch Boulevard San Diego, California 92131-1234
Re : K982366 QUANTA Lite™ Tissue Transglutaminase ELISA Trade Name: Requlatory Class: II Product Code: MVM Dated: July 6, 1998 Received: July 7, 1998
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 qeneral controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbrandinq 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 Requlations, 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 leqally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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): 长982344
Device Name: tTG (tissue transglutaminase) ELISA
Indications For Use:
An Enzyme Linked Immunosorbant Assay (ELISA) for the semi-IqA antibodies tissue quantitative detection of of to transqlutaminase (endomysium) in human serum. Detection of these antibodies is an aid in diaqnosis of certain gluten sensitive such as celiac disease and dermatitis enteropathies herpetiformis.
Peter E. Makin
(Division Sign-Off Division of Clinical Laboratory Devi 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)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)