# K071711: Asca-Chek

- Pathway: 510(k) (Traditional)
- Applicant: Techlab Inc., Corporate Research Center
- Decided: Nov 7, 2007 after 138 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
Longest line of descent: 1 generation back to DEN000007 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN000007: Quanta Lite Asca (S. Cerevisiae) Igg Elisa, Inova Diagnostics, Inc. (2000). Our reading of the summary gave K000732, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN000007, Quanta Lite Asca (S. Cerevisiae) Igg Elisa (Inova Diagnostics, Inc.), granted Aug 16, 2000; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
- K000733: Quanta Lite Asca (S. Cerevisiae) Iga Elisa, Inova Diagnostics, Inc. (2001) Summary page 1.

## Indications for use
The ASCA-CHEK test is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of human anti-S. cerevisiae antibodies (ASCA) in feces and serum. The test result is used as an aid in the diagnosis of Crohn's disease in combination with clinical and other laboratory findings. FOR IN VITRO DIAGNOSTIC USE.

Source page: https://510kreport.com/device/K071711
Methodology: https://510kreport.com/methodology