IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)

• K Number: K032860
• Device Name: IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)
• Manufacturer: IMMCO DIAGNOSTICS, INC.
• Date Cleared: 2004-03-18 ( 188 days)
• Product Code: NBT
• Regulation Number: 866.5785
• Type: Traditional
• Panel: IM
• Reference & Predicate Devices: N/A

Intended 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).

Device Description

An enzyme linked immunosorbent assay (ELISA) for the detection and semiquantitation of anti-Saccharomyces cerevisiae IgA antibodies in human serum.

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for the ImmuLisa Anti-Saccharomyces cerevisiae Antibody (ASCA) IgA ELISA.

This type of document primarily confirms that the device is substantially equivalent to a legally marketed predicate device and grants permission to market it. It does not contain the detailed study information, acceptance criteria, or performance data that you are requesting.

Therefore, I cannot extract the following information from the given text:

1. A table of acceptance criteria and the reported device performance: This information is typically found in the technical documentation submitted with the 510(k) application, not in the clearance letter itself.
2. Sample size used for the test set and the data provenance: Not available in this document.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not available.
4. Adjudication method for the test set: Not available.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable to an ELISA diagnostic kit in this context, but also not available.
6. If a standalone performance (algorithm only) was done: Not applicable to an ELISA kit, but also not available.
7. The type of ground truth used: Not explicitly stated for the studies.
8. The sample size for the training set: Not available.
9. How the ground truth for the training set was established: Not available.

The document states the "Indications For Use" which is: "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)." This is the purpose of the device, but not its performance metrics or study details.

To get the information you are seeking, you would need to refer to the actual 510(k) submission documentation or scientific publications related to the ImmuLisa ASCA IgA ELISA, which are not provided here.

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.”