# K961913: Quanta Lite Ena 6 Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Jul 10, 1996 after 54 days
- Product code: LLL (Extractable Antinuclear Antibody, Antigen And Control)
- Device class: 2
- Regulation: 21 CFR 866.5100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K072149: Elia Symphony Immunoassay, Ana Control, Model 14-55508-01,83-1004-01 (2008), 2 descendants of its own
- K190710: EliA SymphonyS Immunoassay (2019), 1 descendant of its own
- K253367: EliA CTD 13 Screen (2026), 0 descendants of its own

Source page: https://510kreport.com/device/K961913
Methodology: https://510kreport.com/methodology