(292 days)
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No
The summary describes an ELISA assay, which is a laboratory test based on biochemical reactions, not AI/ML. There are no mentions of AI, ML, image processing, or data analysis methods typically associated with AI/ML.
No
The device is described as an immunoassay for diagnostic purposes (detecting antibodies to aid in the diagnosis of celiac disease), not for treating or preventing a disease.
Yes
The stated "Intended Use / Indications for Use" directly references aiding "in the diagnosis of gluten sensitive enteropathy / celiac disease (CD)".
No
The 510(k) summary describes an Enzyme-Linked Immunosorbent 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 that the device is an "Enzyme linked immunoassay (ELISA) for the qualitative and semiquantitative detection of anti-human Tissue Transglutaminase IgA or IgG antibodies in human serum". This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide information about a person's health status (diagnosis of celiac disease).
- Sample Type: The device uses "human serum," which is a biological sample taken from a patient.
- Purpose: The purpose is to "aid in the diagnosis of gluten sensitive enteropathy / celiac disease (CD) in conjunction with other laboratory and clinical findings." This is a diagnostic purpose, which is a key characteristic of IVDs.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly fits that description.
N/A
Intended Use / Indications for Use
Enzyme linked immunoassays (ELISA) for the qualitative and semiquantitative detection of anti-human Tissue Transglutaminase IgA or IgG antibodies in human serum to aid in the diagnosis of gluten sensitive enteropathy / celiac disease (CD) in conjunction with other laboratory and clinical findinas.
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
Prescription Use
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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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains 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 suggest the wings and body of the bird.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
IMMCO Diagnostics, Inc. c/o Mr. Kevin J. Lawson VP. Regulatory Affairs 60 Pineview Drive Buffalo, NY 14228
MAR 1 0 2010
Re: K091520
Trade/Device Name: ImmuLisa™ Celiac tTG rHuman Tissue Transglutaminase IgA
Antibody ELISA
ImmuLisaTM Celica tTG rHuman Tissue Transglutaminase IgG Antibody ELISA
Regulation Number: 21 CFR § 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MVM Dated: February 15, 2010 Received: February 16, 2010
Dear Mr. Lawson:
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 class II (Special Controls), 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
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Page 2 – Mr. Kevin J. Lawson
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRI-l's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
ia m chan
Maria M. Chan, Ph.D. 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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Indications for Use
510(k) Number (if known): K091520
Device Name: ImmuLisa™ Celiac tTG rHuman Tissue Transglutaminase Antibody ELISAs
Indications For Use: Enzyme linked immunoassays (ELISA) for the qualitative and semiquantitative detection of anti-human Tissue Transglutaminase IgA or IgG antibodies in human serum to aid in the diagnosis of gluten sensitive enteropathy / celiac disease (CD) in conjunction with other laboratory and clinical findinas.
Prescription Use __ V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Reena Philip
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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510K K091520