# K983921: Autostat II Ena Screen Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Cogent Diagnotics, Ltd.
- Decided: Dec 28, 1998 after 54 days
- Product code: LLL (Extractable Antinuclear Antibody, Antigen And Control)
- Device class: 2
- Regulation: 21 CFR 866.5100
- 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 results of the ENA screen assay can be used as an aid in the diagnosis of auto-immune diseases including Systemic Lupus Erythematosus (SLE), Sjogren’s Syndrome (SS), Mixed Connective Tissue Disease (MCTD), Poly/Dermato Myositis (PM/DM), Scleroderma and CREST. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K983921
Methodology: https://510kreport.com/methodology