(144 days)
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No
The provided text describes an in-vitro diagnostic assay for measuring autoantibodies and contains no mention of AI, ML, or related concepts.
No
Explanation: The device is an in-vitro diagnostic assay used to measure autoantibodies for the diagnosis of Coeliac disease, not to treat it.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the assay is "as an aid in the diagnosis of Coeliac disease," which directly indicates its diagnostic purpose.
No
The intended use describes an "in-vitro measurement" using an "assay" on "human serum," which strongly suggests a laboratory-based test involving physical reagents and equipment, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "This assay is designed for the in-vitro measurement..."
- "...present in human serum..."
- "...as an aid in the diagnosis of Coeliac disease."
These phrases are key indicators of an in vitro diagnostic device, which is used to examine specimens from the human body outside of the body to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
Bindazyme® Human IgG Anti-Tissue Transglutaminase Enzyme Immunoassay Kit: This assay is designed for the in-vitro measurement of specific IgG autoantibodies against tissue transglutaminase (tTG) present in human serum, as an aid in the diagnosis of Coeliac disease.
Bindazyme® Human IgA Anti-Tissue Transglutaminase Enzyme Immunoassay Kit: This assay is designed for the in-vitro measurement of specific IgA autoantibodies against tissue transglutaminase (tTG) present in human serum, as an aid in the diagnosis 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 (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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 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 an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that overlap each other.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
The Binding Site c/o Mr. Jay H. Geller West Tower, Suite 4000 2425 West Olympic Blvd Santa Monica, CA 90404
JUL 16 2004
Re: K040466
Trade/Device Name: Bindazyme® Human IgG Anti-Tissue Transglutaminase Enzyme Immunoassay Kit Bindazyme® Human IgA Anti-Tissue Transglutaminase Enzyme Immunoassay Kit Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MVM Dated: June 15, 2004 Received: June 17, 2004
Dear Mr. Geller:
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.
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 does 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); labeling (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 device 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,
Robert L. Becker Jr.
Robert L. Becker, Jr., M.D., Ph. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Bindazyme® Human IgG Anti-Tissue Transglutaminase Device Name: Enzyme Immunoassay Kit
This assay is designed for the in-vitro Indications for Use: of specific IgG autoantibodies aqainst tissue measurement transglutaminase (tTG) present in human serum, as an aid in the diagnosis of Coeliac disease.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mana Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040466
Prescription Use_ / (Per 21 CFR 801.109) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
3
Bindazyme® Human IgA Anti-Tissue Transglutaminase Device Name: Enzyme Immunoassay Kit
This assay is designed for the in-vitro Indications for Use: measurement of specific IqA autoantibodies against tissue transglutaminase (tTG) present in human serum, as an aid in the diagnosis of Coeliac disease.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mara Chan
Division Sign-Off
Office of In Vitro Dlagnostic Device Evaluation and Safety
510(K) KO40466
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Prescription Use / (Per 21 CFR 801-109) OR
(Optional Format 1-2-96)