An enzyme linked immunosorbent assay (ELISA) for the detection and semiquantitation of anti-Saccharomyces cerevisiae IgG antibodies in human serum of patients with inflammatory bowel disorder (IBD) as an aid in the diagnosis of Crohn's disease (CD).

Device Description

AI/ML Overview

This is a fantastic request that requires careful reading and understanding of the provided text. Unfortunately, the provided document is a 510(k) clearance letter from the FDA, and does not contain the detailed study information you are asking for.

The letter explicitly states: "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..."

This means the Immulisa Anti-Saccharomyces cerevisiae Antibody (ASCA) IgG ELISA device received clearance based on its substantial equivalence to a previously approved device, not necessarily on a de novo study reporting detailed acceptance criteria and performance against those criteria as you've requested for an AI/device study.

For a 510(k) clearance based on substantial equivalence, the manufacturer typically provides analytical and often some clinical performance data to demonstrate that their new device performs as well as the predicate device. However, the specific format and level of detail about acceptance criteria, sample sizes, expert adjudication, etc., as you've outlined, are usually found in comprehensive study reports or regulatory submissions, which are not part of this public 510(k) clearance letter.

Therefore, I cannot extract the information you've requested from the provided text.

To answer your prompt with the requested details, you would typically need access to the full 510(k) submission document (which is usually proprietary unless specifically released or referenced in public databases) or published studies by the manufacturer.

Summary of why the information cannot be provided from the given text:

Type of Document: This is an FDA 510(k) clearance letter, confirming "substantial equivalence," not a detailed study report.
Basis for Clearance: Substantial equivalence relies on comparison to a predicate device, not necessarily a new, standalone clinical trial defining and hitting novel acceptance criteria in the way you've described.
Missing Details: The letter does not contain:
- Specific acceptance criteria values.
- Reported device performance metrics against those criteria.
- Sample sizes for test sets or training sets.
- Data provenance.
- Number or qualifications of experts.
- Adjudication methods.
- Information on MRMC comparative effectiveness studies.
- Details on standalone performance.
- How ground truth was established for training or test sets.

I apologize that I cannot fulfill your request with the provided material, as the necessary information is simply not present in this type of regulatory correspondence.

Summary

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three parallel lines above them.

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

K032850 Re:

Trade/Device Name: ImmuLisa Anti-Saccharomyces cerevisiae Antibody (ASCA) IgG ELISA Regulation Number: 21 CFR 866.5785 Regulation Name: Anti-Saccharomyces cerevisiae (S. cercvisiae) 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 Fedcral 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 FI>A 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, US, 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): K.O32850

Device Name: ImmuLisa Anti-Saccharomyces cerevisiae Antibody (ASCA) IgG ELISA

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

J. Reeves for M. Chen

linical Laboratory Devices

510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use OR (Optional Format 1-2-96)

Regulation Number and Section

§ 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.”