(57 days)
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No
The summary describes an EIA kit for measuring autoantibodies, which is a standard laboratory assay and does not mention any AI/ML components or image processing.
No
The device is an in-vitro diagnostic (IVD) test kit used to aid in the diagnosis of Coeliac disease by measuring autoantibodies. It does not provide treatment or therapy.
Yes
The device is described as an "aid in the diagnosis of Coeliac disease," indicating its purpose is to assist in identifying a medical condition.
No
The device description clearly states it is an "EIA Kit," which is a laboratory assay kit containing reagents and physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "in-vitro measurement of specific autoantibodies against tissue transglutaminase (tTG) present in serum as an aid in the diagnosis of Coeliac disease." This clearly indicates the device is used to test samples taken from the human body (serum) outside of the body (in-vitro) for diagnostic purposes.
- Device Description: The device is described as an "EIA Kit," which is a common format for in-vitro diagnostic tests.
The definition of an IVD is a medical device that is used to examine specimens derived from the human body in vitro to provide information for diagnostic, monitoring, or compatibility purposes. This device fits that definition perfectly.
N/A
Intended Use / Indications for Use
The in-vitro measurement of specific for Use: Indications autoantibodies against tissue transglutaminase (tTG) present in aucoantibodies againbo extremismosis of Coeliac disease.
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 circular seal for the Department of Health & Human Services USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is an abstract symbol that resembles three stylized human profiles facing to the right, with flowing lines suggesting movement or connection.
DEC 2 1 1999
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
Re: K993612
Trade Name: BINDAZYME Anti-Tissue Transglutaminase IgA EIA Regulatory Class: II Product Code: MVM Dated: October 21, 1999 Received: October 25, 1999
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 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 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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INDICATIONS FOR USE STATEMENT
BINDAZYME
Onti-Tissue Transglutaminase IgA Enzyme Immunoassay Device Name: Kit
The in-vitro measurement of specific for Use: Indications autoantibodies against tissue transglutaminase (tTG) present in aucoantibodies againbo extremismosis of Coeliac disease.
Prescription use $\checkmark$
Tau E. Makeri