# K983376: The Aptus (Automated) Applicaton of the Ena Screen Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for S

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Nov 18, 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 presence of autoantibodies to a number of nuclear constituents has proven to be useful in the diagnosis of various connective tissue diseases. Although the exact etiology of autoimmune diseases is unknown, and the specific role played by autoantibodies in the onset of various autoimmune connective tissue diseases is obscure, the association and frequency of detection of these antibodies may play a key role in the diagnostic work-up of patients with suspected connective tissue diseases. The ENA Screen ELISA test system is intended for the manual or automated analysis of human serum for the presence or absence of IgG antibodies to all six common extractable nuclear antigens (SSA, SSB, Sm, Sm/RNP, Jo-1 and Scl-

Source page: https://510kreport.com/device/K983376
Methodology: https://510kreport.com/methodology