# K980337: Diamedix Immunosimplicity Ana (IS-Ana) Screen Test System

- Pathway: 510(k) (Traditional)
- Applicant: Helix Diagnostics, Inc.
- Decided: May 12, 1998 after 104 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 Diamedix Immunosimplicity ANA (Is-ANA) Screen is a qualitative enzyme immunoassay (EIA) intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain systemic rheumatic diseases. This assay collectively detects in one well, total ANAs against double stranded DNA (dsDNA, nDNA), Histones, SSA/Ro, SSB/La, Sm, Sm/RNP, Scl-70, Jo-1 and centromeric antigens along with sera positive for Immunofluorescent (IFA) HEp-2 ANAs. These reagents can be used either manually or in conjunction with the MAGO™ Automated EIA Processor [510(k) number K973177]. For In Vitro Diagnostic Use.

Source page: https://510kreport.com/device/K980337
Methodology: https://510kreport.com/methodology