# K050662: Quanta Lite SP100 Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Jun 13, 2005 after 90 days
- Product code: NUM (Autoantibodies, Nuclear Body Protein, Sp100)
- Device class: 2
- Regulation: 21 CFR 866.5090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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

## Indications for use
The QUANTA LiteTM sp1iO kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of anti-sp100 antibody of the IgG class in human serum. This test is intended to aid in the diagnosis of primary biliary cirrhosis (PBC).

Source page: https://510kreport.com/device/K050662
Methodology: https://510kreport.com/methodology