# K042579: Bindazyme Human Asca Igg and Iga Eia Diagnostic Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site
- Decided: Jul 28, 2005 after 309 days
- Product code: NBT (Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae))
- Device class: 2
- Regulation: 21 CFR 866.5785
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
This assay is intended for the in vitro semi-quantitative measurement of ASCA IgA anti-Saccharomyces cerevisiae antibody in human serum. The presence of ASCA may aid in the diagnosis of patients with Crohn's disease. The test results should be used in conjunction with clinical findings and other laboratory tests. The ASCA IgA should not be used alone as a screening test for ASCA. ASCA IgA test should be used to complement, but not to replace or to substitute the ASCA IgG antibody test since some Crohn's disease subgroup patients may not have IgA antibodies.

Source page: https://510kreport.com/device/K042579
Methodology: https://510kreport.com/methodology