(203 days)
Not Found
Not Found
No
The summary does not mention AI, ML, image processing, or any other indicators of AI/ML technology.
No
The device is described as a "kit" for "screening of antibodies" as an "aid in the diagnosis" of certain diseases. This indicates a diagnostic purpose, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" states that the kit is "as an aid in the diagnosis of pemphigus and bullous pemphigoid respectively" and "as an aid in the diagnosis of celiac disease," which directly indicates its purpose in the diagnostic process.
No
The provided 510(k) summary describes a "kit" intended for screening antibodies in human serum. This strongly suggests a laboratory-based diagnostic test involving reagents and potentially hardware for analysis, not a software-only device. The lack of information about software, image processing, or AI further supports this conclusion.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use clearly states that the kit is used for screening antibodies in human serum to aid in the diagnosis of specific diseases (pemphigus, bullous pemphigoid, and celiac disease). This involves testing a sample taken from the human body (serum) outside of the body (in vitro) to provide information for diagnostic purposes. This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This kit is intended for screening of antibodies to intra-epidermal antigens or basement membrane zones in human serum as an aid in the diagnosis of pemphigus and bullous pemphigoid respectively. It can also be used for screening of endomysial antibodies as an aid in the diagnosis of celiac disease.
Product codes
MVM
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling an abstract representation of people.
OCT 2 2 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
The Binding Site, Limited C/O Mr. Jay H. Geller East Tower, Suite 600 2425 West Olympic Boulevard Santa Monica, California 90404
K981209/S1 Re : Monkey Oesophagus IFA Kit Trade Name: Regulatory Class: II Product Code: MVM Dated: August 4, 1998 Received: August 11, 1998
Dear Mr. Geller:
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 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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Page 2
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 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 regulation (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 Butman
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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Page_of_______________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): K981209 Oesophagus IFA Kit Device Name:
INDICATIONS FOR USE STATEMENT
Monkey Oesophagus IFA Kit Device Name:
This kit is intended for screening of Indications for Use: antibodies to intra-epidermal antigens or basement membrane zones in human serum as an aid in the diagnosis of pemphigus and bullous pemphigoid respectively. It can also be used for screening of endomysial antibodies as an aid in the diagnosis of celiac disease.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter G. Maurer
Laboratory Devices
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)