# K032860: Immulisa Anti-Saccharomyces Cerevisiae Antibody (Asca) (Iga)

- Pathway: 510(k) (Traditional)
- Applicant: Immco Diagnostics, Inc.
- Decided: Mar 18, 2004 after 188 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K051927: Techlab Asca-Chek (2006), 0 descendants of its own

## Indications for use
An emnyme linked immunosorbent assay (ELISA) for the detection and semi-quantilation of anti-Saccharomycescerevisiae IgA antibodies in human serum of patients with inflammatory bowel disorder (IBD) as an aid in the diagnosis of Cro6rn's disease (CD).

Source page: https://510kreport.com/device/K032860
Methodology: https://510kreport.com/methodology