# K021482: Quanta Lite Sla (Soluble Liver Antigen) Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Jul 30, 2002 after 83 days
- Product code: NIY (Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis)
- Device class: 2
- Regulation: 21 CFR 866.5660
- 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’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K113439: Euroimmun Euroline Profile Autoimmune Liver Disease 8AG (Igg) (2013), 0 descendants of its own
- K112221: Euroimmun Anti-Sla/LP Elisa (LGG) (2012), 0 descendants of its own

## Indications for use
The QUANTA LiteTMSLA (soluble liver antigen) kit is an enzyme-linked irnrnunosorbent assay (ELISA) for the semi-quantitative detection of anti-SLA (soluble liver antigen) antibody of the IgG class in human serum. This test is intended to aid in the diagnosis of conditions with elevated levels of anti-SLA antibody including autoimmune hepatitis (AI H).

Source page: https://510kreport.com/device/K021482
Methodology: https://510kreport.com/methodology