# K061842: Quanta Lite PBC Screen Igg/Iga Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Oct 18, 2006 after 111 days
- Product code: NRI (Autoantibodies, Nuclear Pore Glycoprotein Gp210)
- 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The QUANTA Lite PBC Screen IgG/IgA ELISA is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of mitochondrial antibodies, gp210 antibodies, and sp100 antibodies of the IgG and/or IgA class in human serum. The presence of mitochondrial, gp210, and sp100 antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of primary biliary cirrhosis.

Source page: https://510kreport.com/device/K061842
Methodology: https://510kreport.com/methodology