(50 days)
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No
The summary describes a standard ELISA assay for detecting antibodies and mentions an automated instrument for processing, but there is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.
No.
This device is an in vitro diagnostic assay used to aid in the diagnosis of certain auto-immune diseases by detecting autoantibodies; it does not directly treat or alleviate a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the results "can be used as an aid in the diagnosis of auto-immune diseases."
No
The device description clearly states it is an "Enzyme linked immunosorbent assay method," which is a laboratory test involving physical reagents and equipment, not solely software. It also mentions use with an "automated EIA instrument," further indicating hardware involvement.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it's an "Enzyme linked immunosorbent assay method for the semi-quantitative determination specific IgA autoantibodies to tissue transglutaminase (tTg) in human serum." It also states the results "can be used as an aid in the diagnosis of auto-immune diseases associated with elevated levels of anti-tTg antibodies including Coeliac Disease." This clearly indicates the device is intended to be used in vitro (outside the body) to examine a human specimen (serum) for diagnostic purposes.
- "For in vitro diagnostic use only." This statement is a direct declaration that the device is intended for IVD use.
- Prescription Use (Per 21 CFR 801.109): While not a definitive marker of IVD status on its own, the requirement for prescription use often aligns with devices used in a clinical laboratory setting for diagnostic purposes.
The combination of these factors strongly confirms that this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Enzyme linked immunosorbent assay method for the scmi-quantitative determination specific IgA autoantibodies to tissue transglutaminase (tTg) in human securi.
Uses:
The results of the anti-tTg assay can be used as an aid in the diagnosis of auto-immun diseases associated with elevated levels of anti-tTg antibodies including Coeliac Discuss a Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regine.
This device can be used with the HYCOR HY.TEC automated EIA instrument.
For in vitro diagnostic use only.
Prescription Use (Per 21 CFR 801.109)
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 shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract design of an eagle with three heads, symbolizing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Danielle M. Knight Quality Manager Hycor Biomedical Limited Pentlands Science Park Bush Loan Penicuik EH26 OPL United Kingdom
K033744 Trade/Device Name: Autostat II Anti-tTg IgA ELISA Regulation Number: 21 CFR § 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: II Product Code: MVM Dated: January 6, 2004
Dear Mr. Knight:
Received: January 8, 2004
Re:
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.
JAN 2 0 2004
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 docs 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); labcling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your devicc as described in your Section 510(k) premarket notification. The 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.
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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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
itwen Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use.
Enzyme linked immunosorbent assay method for the scmi-quantitative determination specific IgA autoantibodies to tissue transglutaminase (tTg) in human securi.
Uses:
The results of the anti-tTg assay can be used as an aid in the diagnosis of auto-immun diseases associated with elevated levels of anti-tTg antibodies including Coeliac Discuss a Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regine.
This device can be used with the HYCOR HY.TEC automated EIA instrument.
For in vitro diagnostic use only.
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
H. Reeves for T. J. O'Leary
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K033744