LogoFDA 510(k) Search
K Number
K051492
Device Name
AESKULISA ASCA A
Manufacturer
AESKU.INC
Date Cleared
2005-11-14

(161 days)

Product Code
NBT
Regulation Number
866.5785
Type
Traditional
Panel
IM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

AESKULISA ASCA-A is a solid phase enzyme immunoassay (ELISA) employing purified mannan for the semi-quantitative and qualitative detection of IgA anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum. ASCA recognize specifically mannan, a component of the outer cell wall of yeast. The AESKULISA ASCA A kit should not be used as a screening test for ASCA, since some Crohn's disease patients do not have ASCA IgA antibodies. The AESKULISA ASCA A kit should be used to compliment, but not to replace or to substitute for ASCA IgG antibody testing. The assay is an aid in the diagnosis of Crohn's disease and should be used in conjunction with other serological tests and clinical findings.

AESKULISA ASCA-G is a solid phase enzyme immunoassay (ELISA) employing purified mannan for the semi-quantitative and qualitative detection of IgG anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum. ASCA recognize specific mannan, a component of the outer cell wall of yeast. The assay is an aid in the diagnosis of Crohn`s disease and should be used in conjunction with other serological tests and clinical findings.

Device Description

solid phase enzyme immunoassay (ELISA) employing purified mannan

AI/ML Overview

The provided text does not contain detailed information about acceptance criteria for device performance or the specifics of a study conducted to prove the device meets such criteria. The document is an FDA 510(k) clearance letter for the AESKULISA ASCA-A and AESKULISA ASCA-G devices, indicating that they were found substantially equivalent to predicate devices. It focuses on regulatory aspects rather than detailed performance study results.

Therefore, I cannot provide the requested information in the structured format because the content is not present in the given document.

Missing Information:

  1. A table of acceptance criteria and the reported device performance.
  2. Sample size used for the test set and the data provenance.
  3. Number of experts used to establish the ground truth for the test set and their qualifications.
  4. Adjudication method for the test set.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
  6. If standalone (algorithm only) performance was done.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
  8. The sample size for the training set.
  9. How the ground truth for the training set was established.

§ 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.”