(188 days)
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No
The summary describes a standard ELISA assay, which is a laboratory technique for detecting and quantifying substances. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
The device is an in vitro diagnostic (IVD) test used to detect antibodies for diagnostic aid, not for treating a condition.
Yes
The device is described as "an aid in the diagnosis of Crohn's disease (CD)".
No
The device description clearly states it is an "enzyme linked immunosorbent assay (ELISA)", which is a laboratory test involving physical reagents and equipment, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's an "enzyme linked immunosorbent assay (ELISA) for the detection and semiquantitation of anti-Saccharomyces cerevisiae IgA antibodies in human serum". This involves testing a sample taken from the human body (serum) in vitro (outside the body).
- Purpose: The purpose is "as an aid in the diagnosis of Crohn's disease (CD)". This is a diagnostic purpose, which is a key characteristic of IVDs.
- Device Description: The device description confirms it's an "enzyme linked immunosorbent assay (ELISA) for the detection and semiquantitation of anti-Saccharomyces cerevisiae IgA antibodies in human serum". This further reinforces the in vitro nature of the test.
The definition of an IVD generally involves devices 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
An enzyme linked immunosorbent assay (ELISA) for the detection and semiquantitation of anti-Saccharomyces cerevisiae IgA antibodies in human serum of patients with inflammatory bowel disorder (IBD) as an aid in the diagnosis of Crohn's disease (CD).
Product codes
NBT
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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§ 866.5785 Anti-
Saccharomyces cerevisiae (S. cerevisiae ) antibody (ASCA) test systems.(a)
Identification. The Anti-Saccharomyces cerevisiae (S. cerevisiae ) antibody (ASCA) test system is an in vitro diagnostic device that consists of the reagents used to measure, by immunochemical techniques, antibodies toS. cerevisiae (baker's or brewer's yeast) in human serum or plasma. Detection ofS. cerevisiae antibodies may aid in the diagnosis of Crohn's disease.(b)
Classification. Class II (special controls). The special control is FDA's “Guidance for Industry and FDA Reviewers: Class II Special Control Guidance Document for Anti-Saccharomyces cerevisiae (S. cerevisiae ) Antibody (ASCA) Premarket Notifications.”
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest wings and a head.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 8 2004
Mr. Kevin J. Lawson Director of Regulatory Affairs IMMCO Diagnostics, Inc. 60 Pineview Dr. Buffalo, NY 14228
Re: K032860
Trade/Device Name: ImmuLisa Anti-Saccharomyces cerevisiae Antibody (ASCA) IgA ELISA Regulation Number: 21 CFR 866.5785 Regulation Name: Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test systems Regulatory Class: Class II Product Code: NBT Dated: December 23,2003 Received: February 10, 2004
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 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).
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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 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,
Jean M. Cooper, MS, DVM.
Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): KO32860
Device Name: ImmuLisa Anti-Saccharomyces cerevisiae Antibody (ASCA) IgA ELISA
Indications For Use:
An enzyme linked immunosorbent assay (ELISA) for the detection and semiquantitation of anti-Saccharomyces cerevisiae IgA antibodies in human serum of patients with inflammatory bowel disorder (IBD) as an aid in the diagnosis of Crohn's disease (CD).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Af Rivers for M. Chan
(Division of "On")
Division of Clinical Laboratory Devices
510(k) Number `KU31860
OR
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use (Optional Format 1-2-96)