# K980312: Nova Lite Endomysial

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Apr 2, 1998 after 65 days
- Product code: DBL (Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control)
- 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.
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
An indirect immunofluorescent antibody test for the qualitative and semi-quantitative detection of IgA class endomysial autoantibodies (EMA) in human serum as an aid in the diagnosis of celiac disease and dermatitis herpetiformis.

Source page: https://510kreport.com/device/K980312
Methodology: https://510kreport.com/methodology