# K983378: The Aptus (Automated) Application of the Ana Screen Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for.

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Nov 18, 1998 after 54 days
- Product code: LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls)
- 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 ANA Screen ELISA test system is intended for the manual or automated analysis of human serum for the presence or absence of IgG antibodies to a variety of nuclear antigens such as those directed against double stranded DNA, Jo-1, Sm, Sm/RNP, SSA, SSB, and Scl-70. The test system is also capable of detecting ANA demonstrating the centromere, nucleolar, peripheral and spindie IFA patterns.

Source page: https://510kreport.com/device/K983378
Methodology: https://510kreport.com/methodology