# DEN000007: Quanta Lite Asca (S. Cerevisiae) Igg Elisa

- Pathway: De Novo (Post-NSE)
- Applicant: Inova Diagnostics, Inc.
- Decided: Aug 16, 2000 after 29 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. De Novo decisions do not claim a predicate device.

## 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/DEN000007
Methodology: https://510kreport.com/methodology