# K000733: Quanta Lite Asca (S. Cerevisiae) Iga Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: May 21, 2001 after 441 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K071711: Asca-Chek (2007), 0 descendants of its own
- K051927: Techlab Asca-Chek (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K000733
Methodology: https://510kreport.com/methodology