(188 days)
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).
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).
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.
§ 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.”