# K982150: EL-Ana Profiles: EL-Ena/4

- Pathway: 510(k) (Traditional)
- Applicant: Theratest Laboratories, Inc.
- Decided: Aug 13, 1998 after 56 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 TheraTest EL-ANA Profiles: EL-ENA/4 is an in vitro diagnostic test for the screening of autoantibodies in human serum directed against the following extractable nuclear antigens: Sm, nRNP, SSA and SSB. This screening aids in the diagnosis of systemic lupus erythematosus and related autoimmune disorders.

Source page: https://510kreport.com/device/K982150
Methodology: https://510kreport.com/methodology