# K021648: Quanta Lite Actin (Anti-Smooth Muscle) Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Sep 20, 2002 after 123 days
- Product code: NJF (Antibodies, Anti-Actin, Anti-Smooth Muscle)
- Device class: 2
- Regulation: 21 CFR 866.5120
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The QUANTA Lite™ Actin ELISA kit is an enzyme-linked immunosorbent assay (ELISA) for the semiquantitative detection of IgG antibodies to the actin component of smooth muscle in human serum. Detection of these antibodies is an aid in diagnosis of certain autoimmune liver diseases such as autoimmune hepatitis (AIH) and primary biliary cirrhosis (PBC).

Source page: https://510kreport.com/device/K021648
Methodology: https://510kreport.com/methodology